Careers

Join Our Team.

There has never been a more exciting time at Rani Therapeutics. We have successfully tested the RaniPill in humans, and we are working towards the ultimate goal of making the oral delivery of biologics a reality for millions of patients. We are growing rapidly and we are actively hiring.

Current Openings.

We are actively hiring and building our team. Check out some of our current open positions. If you think you have the right experience, and would like to be part of a dynamic team, we want to hear from you.

SENIOR MANUFACTURING PROCESS ENGINEER

San Jose, California, United States - Full-time
Description

This role supports the manufacturing of Rani Capsules. Works with engineering and clinical to ensure device specifications conform to device requirements. Responsible for establishing baseline by evaluating the current manufacturing processes and making improvements to increase productivity, quality /reliability, and reduce cost and scrap.

Requirements
  • Evaluate the current manufacturing processes /workflows to identify opportunities for improving productivity and quality while reducing cost /labor
  • Perform process capability studies via DOE’s. Utilize statistical data analysis to arrive at sound conclusions and follow up with action plan for process improvements
  • Develop standards and monitoring techniques to reduce variability in manufacturing that may include operator, material, equipment and processes
  • Actively participate in discussions with appropriate functions and contribute to new initiatives that may include design, manufacturing, process /quality improvement as well as cost reduction
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
  • Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
  • Works with Development Engineers to effectively transfer new products to Manufacturing
  • Complete design and development projects by training and guiding technicians and assemblers
  • Create verification /validation protocols (IQ,OQ,PQ), lead the execution activities, generate relevant data and provide corresponding documentation and reports
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
  • 7+ years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
  • Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines  /processes
  • Knowledge of material science and polymer chemistry
  • Diverse background in process characterization and optimization in a manufacturing environment.
  • Hands-on proactive approach to problem solving
  • Requires interaction and collaboration with a cross-functional team
  • Experience with Statistical Software tools such as Minitab or JMP
  • Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
  • Familiarity with cleaning and sterilization processes
  • Working knowledge of SolidWorks
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

PROCESS ENGINEERING MANAGER

San Jose, California, United States - Full-time
Description
The Manager of Process Engineering is responsible for providing technical leadership and direction to a team of talented engineers. The successful candidate will have extensive experience in the areas of process development/optimization, continuous improvement, and cost reduction as well as verification & validation activities in a fast-paced environment.
This is a hands-on position that requires interaction and collaboration with cross-functional teams including R&D Engineering, Automation Engineering, Manufacturing, Material, Quality, and safety.
Requirements
  • Develop standards and key performance metrics to reduce variability as well as improving quality, throughput, and efficiency
  • Actively participate in early design concept reviews with R&D and Automation Engineering and provide objective feedback to ensure manufacturing robustness
  • Perform equipment characterization and define process windows by creating appropriate DOE’s and utilizing statistical data analysis
  • Own the verification/validation activities including generation of IQ/OQ/PQ protocols, execution and final reports as well as creating SOP’s, MPI’s LHR’s and providing appropriate training
  • Recommend production layouts for automation equipment and material flow for maximum efficiency
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
  • Provide support for existing equipment and ensure proper documentation and training
  • Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques
  • Champion and foster a mindset of quality and continuous improvement
  • Adhere to project timelines, identify risks/issues, and recommend mitigations
  • Attract/hire top talent and ensure retention by providing coaching/mentoring and encouraging career growth
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Bachelor’s Degree in Chemical, Mechanical, Manufacturing, or related engineering fields
  • 5-7 years hands-on experience in the medical device field with proven track record of process development/optimization and validation
  • Minimum 3 years of proven leadership and people management
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards
  • Strong analytical and problem-solving skills including but not limited to DOE and statistical data analysis
  • Extensive experience with process capability studies, FMEA, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes
  • Knowledge of material science and polymer chemistry
  • Experience with Statistical Software tools such as Minitab or JMP
  • Experience with Lean manufacturing

Preferred Qualifications

  • Advanced engineering degree
  • Familiarity with aseptic manufacturing
  • Project management experience
  • Knowledge and experience in plastics assembly techniques
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

 

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MANAGER/SR. MANAGER CMC ANALYTICAL DEVELOPMENT

San Jose, California, United States - Full-time
Description

Rani Therapeutics has developed a disruptive technology, RaniPillTM capsule that facilitates the oral delivery of biologics. Working at Rani Therapeutics involves taking a multi-disciplinary approach based on traditional device technologies such as mechanical engineering and material science in combination with pharma-centric disciplines such as physiology, pharmacology, chemistry and protein therapeutics. This unique environment allows Rani Therapeutics to address the most complex, unsolved problem of oral biologics delivery. The candidate in this position will play a pivotal role in our R&D Department working on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes.

Requirements
  • Comprehensive knowledge of state-of-the-art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc., for product characterization, comparability testing and PK/PD analyses.
  • Hands on experience in stage appropriate method validation and specification setting.
  • Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes.
  • Proven expertise in establishing and managing reference standard and stability programs.
  • Experience in protein purification and biologic formulation is a plus.
  • Participate in method and tech transfer from R&D to Manufacturing as appropriate.
  • Experience in writing, reviewing and approving CMC sections of regulatory filings.
  • Good working knowledge of GMP requirements, including ICH, FDA, and EMA guidelines, for development and manufacturing of drug products and/or drug-device combination products (a plus).
  • Assessing utilization of resources and identifying when, and where additional resources may be needed.
  • Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
  • A track record in collaboration with cross functions, including (but not limited to) Process/Engineering Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs, is required.
  • To communicate effectively to the project team and present data at team meetings.
  • To maintain high quality documentation of all activities in notebooks, reports as required.
  • Keep up to date with relevant scientific and technical developments.

Education and/or Job Experience

  • B.S./M.S. or advanced degree (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related fields.
  • Must have 5+ years of relevant pharmaceutical or biotechnology development experience.
  • Position and compensation will be commensurate with experience.

Qualification

  • A track record in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must.
  • Working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities.
  • Experience of working in GLP/GMP regulated environment.
  • Experience in working with drug-device combination products is a plus.
  • Excellent oral and written communication skills.
  • The ability to work as a member of a multidisciplinary team.
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR AUTOMATION ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking an exceptional Senior Automation Engineer to design, develop and validate controller system hardware and software for semi or fully automated equipment that are used for the scale-up of high volume, disposable devices. You will be analyzing system requirements, creating electrical and pneumatic schematics as well as panel layouts, implementing custom programmable logic code, testing system functionality and efficiency, proving system safety, and providing operational support.

Requirements
  • Working closely with R&D, Manufacturing, and Process Engineering groups to develop concepts and ideas for automation where applicable
  • Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch and documentation
  • Develop engineering designs, including electrical schematics, panel layouts, and bill of materials for equipment. Knowledge of SolidWorks Electrical is a plus
  • Hands on PLC Controls system design, development, programming, and validation
  • HMI/GUI design and implementation. Apply human factors and usability engineering in the development and modification of software interfaces
  • Enable remote management of PLCs, controllers, and HMIs, as well as data logging
  • Work with sustaining and maintenance to understand the root cause of control-related failures.
  • Provide engineering support, technical guidance, and training to operators
  • Able to work on multiple projects simultaneously in a fast-paced, energetic environment and manage competing priorities. Strong planning and organizational skills
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Bachelor’s degree in software engineering, mechanical engineering, electrical engineering, or a related field
  • 5-7 years of hands-on, relevant experience

Qualifications

  • Proficiency expected in one of the following: Allen-Bradley (RSLogix 5000), Siemens, Omron, and or other industry standard PLC platforms
  • Working knowledge of Relay Ladder Logic (RLL). Understanding of Structured Text (ST), Functional Block Diagram (FBD), and Sequential Function Charts (SFC)
  • Experience in writing HMI user interface using FactoryTalk View and other industry standard Graphic User Interfaces
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Ability to troubleshoot equipment problems and perform complex system tests
  • Ability to work with minimal supervision

Preferred Qualifications

  • Advanced engineering degree
  • VFD programming and motor control. Working knowledge with SMC motor driver preferred
  • Experience with robotics (Epson, Denso, Omron), and machine vision
  • PLC technical certification
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR MECHANICAL DESIGN ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking a Senior Mechanical Design Engineer to support a wide variety of engineering activities in a fast-paced environment.  This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Process and Quality.

Requirements
  • Create 3D models and detail drawings by reverse engineering existing tooling and fixtures
  • Work closely with the Engineering and Manufacturing teams to understand design intent and incorporate Geometric Dimensioning and Tolerancing (GD&T)
  • Design new jigs and fixtures for Manufacturing
  • Perform tests and experiments when necessary to collect functional data as it relates to the current tools design
  • Create complete documentation package including Drawings, BOM’s, work instructions, MPI’s, etc. and release on ECO
  • Provide design and documentation support to R&D and Manufacturing Engineering teams
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Minimum 3 years of hands-on experience in a manufacturing environment
  • Good understanding of mechanical/electromechanical design
  • Experience with mechanisms, pneumatics, fixtures/tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings and BOM’s
  • Excellent verbal, written, presentation and interpersonal skills
  • Good understanding of GD&T as well as proficiency with SolidWorks
  • Familiarity with metrology tools
  • Associate degree in a technical field

Preferred Qualifications

  • Knowledge and/or hands-on experience with machine shop tools
  • Knowledge/experience with electrical /electronics
  • Knowledge/experience with plastic injection molding
  • Experience with Micro-Vu
  • Prior experience with FDA regulations, ISO, cGMP and QMS standards
  • Understanding of DFM and lean manufacturing
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR ELECTRICAL ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking an exceptional, highly motivated, and hands-on Senior Electrical Engineer to design, develop and validate novel circuits for medical devices and other non-conventional application circuits. Your role is to find creative and sound engineering solutions to challenging problems with strong focus on quality, reliability, and execution. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, and Biology.

Requirements
  • Collaborate with cross-functional teams to shape future technology integration into our products and define electrical specifications and requirements.
  • Hardware engineering duties include component analysis, circuit design, schematic capture, component placement, PCB routing, prototype bring-up and general debugging.
  • Analog and mixed-signal design and simulation (discrete transistors, op-amps, filters, advanced sensors integration)
  • Digital design (microcontroller, memory, digital interfaces such as I2C/SPI, UART, USB)
  • Wireless protocol integration (Bluetooth and Wi-Fi)
  • Electrical functional verification and signal characterization of all designs.
  • Develop test plans and systems to test designs in lab and manufacturing environments.
  • Model, analysis, and documentation of risks and mitigation strategies, optimizations for efficiency, manufacturability, testability, and overall user experience.
  • Firmware engineering duties may include overall architecture, power management optimization, code implementation, testing and maintenance.

Education and/or Job Experience

  • Bachelor’s degree in electrical engineering or a related field
  • 5-7 years of hands-on, relevant experience

Qualifications

  • Must demonstrate strong EE and firmware fundamentals.
  • Must have hands-on experience in prototype bring-up and debugging, functional verification, and manufacturing support. Ability to solder and rework is a plus.
  • Broad experience in low power embedded system design, including architecture development, component selection, schematic capture, PCB layout, and prototype development. Working experience with Altium Designer is a plus.
  • Deep understanding of wireless communication software and firmware architectures. Experience with Bluetooth LE is preferred.
  • Must demonstrate strong verbal and written communication skills.
  • Strong analytical and problem-solving skills.
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.

Preferred Qualifications

  • Master’s degree in Electrical Engineering or equivalent
  • Knowledge/experience with ultralow power design
  • Knowledge/experience with RTOS with BLE stack
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

ASSOCIATE DIRECTOR/DIRECTOR - VALIDATION

San Jose, California, United States - Full-time
Description
This position is a hands-on role and directs the validation organization responsible for the execution of validation activities. The ideal candidate will develop and implement harmonized validation processes and practices across the company. Develop team of Validation SMEs capable of supporting validation initiatives for clinical and commercial programs, in compliance with the company and regulatory requirements. This role covers validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment. This individual interfaces with Process Engineering, Quality, Facilities, Automation Engineers, Project Managers, and other groups.
Requirements
  • Ensure the development and implementation of validation strategies to ensure compliance with applicable regulatory requirements
  • Develop and enhance validation programs and internal SOPs to reflect regulatory requirements and industry best practices
  • Write and review qualification and validation documents (Validation Master Plan, SOPs, URS, IQ, OQ, PQ, validation summary reports, etc.) in compliance with Rani procedures, good scientific and statistical concepts, and regulatory requirements
  • Lead and support qualification and validation of cGMP equipment, facilities, utility systems, cleaning and manufacturing processes, etc.
  • Develop and maintain risk based, quality driven procedures and practices with respect to qualification/validation testing strategies and requirements. Lead risk assessment activities
  • Identify, hire and develop the company’s validation expertise in all aspects of validation (equipment, cleaning, computer system validation, etc.)
  • Lead validation team including consultants and contractors if applicable, and supervise executions
  • Train and guide applicable personnel on industry validation practices, relevant standards and internal procedures
  • Support the change control program with respect to facility, utilities, equipment, cleaning and computerized systems validation changes. Evaluate validation impact of manufacturing process changes and equipment upgrades
  • Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.
  • Ensure Quality meets or improves on budget, cost and efficiency targets (KPI’s) in line with business objectives
  • Support Quality Assurance activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs
  • Other duties/activities may be necessary to support departmental or company goals
Education and/or Job Experience
  • Bachelor’s degree in life science or Engineering
  • A minimum of 10 years of validation experience within the pharmaceutical or biotechnology industry
  • At least 5 years of direct supervisory-level or managerial-level experience is required
  • Must understand, follow and comply with regulatory requirements as applicable to various processes
  • Knowledge of industry standards and best practices for Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) and validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500
  • Knowledge of international and domestic cGMP regulations for pharmaceutical manufacturing operations, metrology requirements
  • Strong technical writing skills and ability to create technical protocols and reports, as well as standard operating procedures
  • Demonstrated creativity, effectiveness, energy in addressing major strategic challenges
  • Proven track record of establishing clear expectations, setting objectives and delivering results within deadlines
  • Strong problem-solving and analytical skills with strong technical and/or engineering knowledge, and a bias toward action and results
  • Experience in project management
Qualification
  • Excellent communication skills both oral and written
  • Proven ability to lead and motivate people
  • Able to achieve organizational focus on key priorities, operate effectively in a dynamic, fast-paced environment
  • High level of integrity and desire to follow regulations and standards
  • Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions
  • Good statistical and numerical ability
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

CORPORATE COUNSEL

San Jose, California, United States - Full-time

Description

To provide counsel on and support regarding corporate, governance and securities matters.

Requirements

  • Assist in the preparation, review and filing of SEC filings and related documents, including current and periodic reports (e.g., 10-Ks, 10-Qs, 8-Ks), proxy statements, registration statements and other securities law filings.
  • Provide legal advice and support on corporate governance matters, corporate law, transactions and day-to-day operations of the company, including drafting and negotiating contracts.
  • Assist with Board meetings, including preparation and review of board materials and drafting of minutes.
  • Monitor, maintain and implement various corporate governance practices and policies.
  • Assist in drafting and reviewing corporate disclosures and corporate communications, including press releases, earnings releases, and social media posts.
  • Help to develop, implement and improve processes and procedures to enable the law department and company to operate more efficiently and effectively.
  • Provide guidance on corporate law, Sarbanes-Oxley and Nasdaq requirements, as well company trading policy, shareholder matters and stock administration.

Education and/or Job Experience

  • J.D. from accredited law school, member of state bar, undergraduate degree from accredited university or college

Skills and Specifications

  • 4+ years of experience in securities and corporate governance; strong familiarity with securities and corporate laws, including Delaware and California, NASDAQ requirements, and good corporate governance practices.
  • Excellent interpersonal, oral and written communication, and presentation skills.
  • Team player with the ability to work well with internal colleagues, management and board members, external advisors and business clients.
  • Humble, hard-working, high integrity, pragmatic, good judgment, well-organized and able to manage numerous project simultaneously under deadline pressure, and willing to work extended hours when needed.
  • Demonstrated ability to solve problems, adapt quickly, work independently, prioritize workflow, meet demanding deadlines, and manage projects well.
  • Proven track record of taking initiative, being resourceful and taking on additional responsibilities.
  • Familiarity with biotech industry and business preferred.
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR MECHANICAL ENGINEER - R&D

San Jose, California, United States - Full-time

Description

The Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system while maintaining high quality and reliability standards.  This will be achieved by testing the system and optimizing components or subassemblies as needed.   In addition, he/she will be required to work with quality and regulatory to develop complete documentation for the device.  The successful candidate will work independently and use sound judgment to deliver optimal solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Requirement

  • Evaluate the current design and identify opportunities to realize improvement in product consistency and increased throughput in a manufacturing environment
  • Show proof of concept through prototyping and supporting test data, and coordinate implementation with appropriate stakeholders
  • Take full ownership of documentation by following internal design control SOPs, leading verification/validation activities, and participating in phase reviews
  • Create 3D models, engineering drawings and bill of materials
  • Create comprehensive work instructions and manufacturing SOP’s
  • Work with quality to resolve any issues with components or processes
  • Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
  • Comply with company’s policies and guidelines regarding quality and regulatory

Education and/or Job Experience

  • Bachelor’s Degree in Mechanical Engineering
  • 5 plus years hands-on experience in a design environment
  • Experience with creating engineering drawings, BOMs, and product specifications
  • In-depth experience with complex mechanical   systems that interact with biology
  • Prior experience in a medical device company
  • Experience with design control process for medical devices and implementation of product in to manufacturing
  • Working knowledge of FDA regulations and ISO, cGMP, QMS standards
  • Good understanding of DFM and lean manufacturing
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills
  • Knowledge and/or hands-on experience with machine shop tools
  • Proficiency with SolidWorks required
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Qualification

  • Knowledge /experience with plastic injection molding
  • Masters’ degree or higher in Mechanical Engineering or Biomedical Engineering
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

STAFF MECHANICAL ENGINEER - R&D

San Antonio, Texas, United States - Full-Time

Description

Responsible for providing technical leadership in the areas of design for manufacturability and process development/ optimization. This is a hands-on position that requires interaction and collaboration with cross-functional teams including R&D Engineering, Automation Engineering, Manufacturing, Material, Quality, and Safety.

Requirements

  • Actively participate in early design concept review with R&D to provide objective feedback to ensure manufacturing robustness.
  • Work closely with Engineering and Manufacturing to understand design intent and incorporate
  • Geometric Dimensioning and Tolerancing (GD& T).
  • Design new jigs and fixtures for manufacturing.
  • Develop standards and key performance metrics to reduce variability as well as improve quality, throughput, and efficiency.
  • Perform tests and experiments when necessary to collect functional data as it relates to the current tool design.
  • Perform equipment characterization and define process windows by creating appropriate DOEs and utilizing statistical data analysis.
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution.
  • Provide support to existing equipment and ensure proper documentation and training.
  • Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques.
  • Adhere to project timelines, identify risks/issues, and recommend mitigations.
  • Collaborates with coworkers across the organization to document and design how systems work and interact.
  • Clearly communicates technical issues, and ties work clearly to company objectives.
  • Proactively offer regular, constructive feedback to others.
  • Participate in recruiting strong engineers.
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation.

Education and/or Job Experience

  • Bachelor’s Degree in Mechanical, Chemical, Manufacturing, or related engineering fields.
  • 10-12 years hands-on experience in a manufacturing environment with a proven record of process development, optimization, and validation.

Skills and Specifications

  • Proficiency with SolidWorks required.
  • Prior experience in a medical device company.
  • Experience with design control process for medical devices and implementation of product into manufacturing.
  • Good understanding of DFM and lean manufacturing.
  • Knowledge and experience with plastic injection molding.
  • Knowledge and hands-on experience with machine shop tools .
  • Excellent verbal, written, and presentation and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks.
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

VALIDATION ENGINEER

San Jose, California, United States - Full-time
Description
The Validation Engineer position is responsible for defining validation strategy, coordinating and executing validation activities required to complete assigned validation projects.   An ideal candidate would have previous experience with the performance of such validation activities that include process equipment/utility/facility qualification, cleaning validation, and automation system qualification across the entire validation lifecycle from plan to retire.  The Validation Engineer will be responsible for a variety of validation engineering related activities and for resolving challenging issues following cGMP regulations and Rani standards. This position requires a problem-solving mindset with strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation and other groups.

Requirements

  • Serve as the Validation Engineering representative and on cross-functional and multi-site teams related to equipment including equipment, utilities, facility, etc.
  • Generate, support, and/or execute qualification/validation deliverables, such as, but not limited to: validation plans, user’s requirements, functional specifications, requirements traceability matrices, protocols (FAT, SAT, IQ, OQ, PQ) and qualification summary reports, including data analysis and deviations across a wide variety of equipment, utilities and lab instrumentation systems
  • Prepare/Update Validation Master Plans, Project Plans and Master Reports
  • Ensure qualifications are conducted in accordance with the Validation Master Plan
  • Support Factory Acceptance Test (FAT) and Site Acceptance Testing (SAT) for new equipment
  • Assist in writing and revising other documentation including: Standard Operating Procedures, User Requirements Specifications (URS)
  • Lead and participate in risk assessments of new and existing equipment and facilities
  • Tracks and communicates project status, as well as project risks and recommendations to stakeholders
  • Ensuring proper execution and documentation according to cGMP and cGDP
  • Review validation documents executed by CMO’s (Protocols, executed documents, and Reports)
  • Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

  • Bachelor’s degree in Engineering, Life Sciences, or related discipline
  • A minimum of 3 years of validation experience within the pharmaceutical or medical device industry
  • Any additional certifications are a plus (e.g., ASQ-CQA, CQE, CSQE, among others)
  • Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971)
  • Basic understanding and working experience in the development of GMP documentation to support the qualification and validation of GMP equipment and systems
  • Knowledge and experience on statistical analysis of validation test results
  • Experience in technical writing: (e.g. protocol generation and report authoring)
  • Excellent communication skills both oral and written

Qualification

    • Organizing, planning, and problem-solving skills
    • Must possess the ability to handle multiple tasks with high attention to detail
    • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
    • Ability to identify and remediate issues found during testing
    • Good statistical and numerical ability
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

PRODUCTION SUPERVISOR - ASSEMBLY MANUFACTURING

San Jose, California, United States - Full-time
Description
We are seeking a supervisor to lead a team that is responsible for the Capsule Assembly Manufacturing of the RaniPill®.  This is a hands-on position in a fast-paced, regulated environment.  The position is responsible for all aspects of assembly manufacturing including scheduling, resource planning, daily management as well as equipment maintenance and upkeep.

Requirements

  • Manage a team of operators, assemblers, and equipment technicians to lead the daily operations of aseptic manufacturing
  • Execute to the production schedules and resource planning. Manage employee vacations, sick time and other interruptions that might impact the schedule
  • Manage employee attendance and performance through clear communication of goals and expectation.
  • Monitor equipment performance, make recommendations to increase yield, throughput, and quality
  • Review/provide recommendations for Standard Operating Procedures (SOP’s), Manufacturing Process Instructions (MPIs), and other Change controlled processes
  • Ensure accurate documentation of all activities performed according to established SOPs
  • Maintain compliance with applicable regulatory (cGMP), Good Documentation Practices and safety requirements for medical device assembly and drug manufacturing
  • Maintain min/max levels for material/components inside cleanroom
  • Identify areas of improvement, make appropriate recommendations, and facilitate implementation
  • Ensure all SOPs are current, and facilitate training on SOPs, MPIs and other QMS documents
  • Maintain a positive attitude and encourage a supportive team culture using our guiding principles and core values
  • Other duties as assigned

Education and/or Job Experience

  • 5+ years of manufacturing experience in Medical Device or related industry
  • 3+ years of supervisory or lead experience
  • Education: Minimum a two-year college certificate
  • Experience with cleanroom operation/practices and production scheduling
  • Effective verbal and written communication
  • Must be hands-on and willing to step in to run the machines as needed
  • Ability to work on flexible schedule
  • Familiarity with assembling small parts under microscope
  • Proficiency with Microsoft office

Preferred Qualifications

  • Familiarity with sterilization process and cleanroom manufacturing
  • Knowledge and experience with Lean Manufacturing
  • Familiarity with cGMP and FDA regulations

Travel

  • Up to 10%
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR MANUFACTURING ENGINEER

San Jose, California, United States - Full-time

Description

Supports the manufacturing of Rani Capsules. Provides technical assistance in installation, preventative maintenance, and calibration of equipment. Works with R&D engineering and quality to ensure device specifications conform to device requirements. Responsible for supporting the production lines with daily activities, process improvements, cost savings projects, supplier engineering support, and consistency of assembly processes.

Requirements

  • Lead continuous improvement programs to improve, manufacturing processes, equipment performance and reliability. Maximize Mean Time Between Failure (MTBF), Operational Uptime and minimize Mean Time To Repair (MTTR)
  • Support Subject Matter Experts (SMEs) during the design and development of new equipment.  analyze equipment malfunctions and failures and accordingly develop corrective actions
  • Develop improvements to enhance equipment reliability and scalability
  • Develop preventive maintenance procedures to reduce equipment and tooling failures
  • Maintain documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
  • Responsible for manufacturing methods and their transfer into production
  • Follow SOP on re-validation of existing equipment, tooling and processes
  • Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery of goals
  • Work with Quality Control team to generate, update and implement all manufacturing engineering related requests, vendor contact and auditing specification
  • Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
  • Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
  • Complete projects, report status, and document lessons learned in an efficient manner

Education and/or Job Experience

  • BS in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or similar related field
  • 5+ years of engineering experience in manufacturing, design, and assembly
  • 2+ years of experience in Design for Excellence (DFX), Electromechanical equipment, Electrothermal equipment, and various testing equipment
  • SolidWorks or CAD modeling software
  • Experience in new product development, introduction processes and procurement protocols
  • Must be detail oriented, focused and able to produce accurate and professional documents
  • Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.

Preferred Qualifications

  • Master’s degree in engineering
  • Knowledge/experience with plastic injection molding
  • Knowledge/experience with DOE, SPC, JMP /Minitab
  • Experience with metal stamping, laser cutting and chemical etching
  • Familiarity with and sterilization process and aseptic environment
  • PLC programming
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR EQUIPMENT ENGINEER

San Jose, California, United States - Full-time
Description
Supports the manufacturing of Rani Capsules through design, assembly and integration of new equipment. Works closely with Process Engineering, Manufacturing, Vendors and other teams to define, improve and monitor equipment reliability, throughput and process capability.  Defines, deploys, monitors, and improves the Preventive Maintenance specifications, SPC on key parameters, bill of material and spare parts requirement. Reviews, analyzes, and investigates equipment related scraps and provides root cause analysis and effective corrective actions. Provides technical assistance in installation, preventative maintenance, and calibration of equipment.

Requirements

  • Design and implement equipment upgrade to improve reliability and increase production output.
  • Lead or be an active team member to drive continuous improvement programs to improve equipment performance and reliability, maximize Mean Productive Time Between Failure (MTBF), and Operational Uptime (AOU), and minimize Mean Time To Repair (MTTR).
  • Take ownership of the new equipment specification, technical negotiation with vendors, design and documentation review, installation, and qualification testing and documentation.
  • Ensure project is on schedule, and at the same time deliver with the highest quality by proactively identifying and correcting capability, reliability, and Maintenance issues early on.  Document lessons learned in an efficient manner.
  • Develop preventive maintenance procedures to reduce equipment and tooling failures
  • Generate and maintain accurate and detailed documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
  • Follow SOP on re-validation of existing equipment, tooling and processes
  • Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
  • Support equipment related projects which includes but not limited to:
  • Purchasing of new or used equipment, set-up, qualification, and release in production.
  • Manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing, and set up of new equipment.
  • Integration of different equipment aspects (software and hardware).

Education and Job Experience

  • BS, or MS degree in mechanical engineering, electrical engineering, computer engineering or equivalent
  • 7+ years of experience in Equipment Engineering supporting high volume manufacturing.
  • Good hands-on systems integration experience, troubleshooting, and start-up and commissioning of equipment into production environment.
  • Proficient in Solidworks, Autocad, and GD&T.
  • Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus.
  • Working knowledge of lean manufacturing.
  • Superior communication skills, (written, verbal and active listening.)
  • Highly motivated self-starter, capable of self-management with little to no oversight
  • Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. is a plus.
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

ASSEMBLER

San Jose, California, United States - Full-time
Description
Primary job function is to assemble parts and components used in the manufacture of medical devices.

Requirements

  • Perform assembly operations requiring fine hand dexterity.
  • Understand and comply with Good Manufacturing Practices and Good Documentation Practices.
  • Comply with work schedules and properly report hours worked.
  • Have the ability to initial and date and write notes and other entries legibly.
  • Comply with all written procedures and safety practices.
  • Read and understand procedures written in English.
  • Assist in writing and updating assembly procedures, protocols and checklists.
  • Evaluate problems and make initial recommendations for possible corrective actions for issues encountered on the line.
  • Work with production management and Quality Assurance to provide feedback regarding assembly procedures.
  • Assure product and process quality by following Quality System procedures.
  • Maintain product and company reputation by complying with government regulations.

Education and/or Job Experience

  • High School Diploma or equivalent
  • 2+ years of experience in Medical Device or Pharmaceutical company
  • Must have good English written and verbal communication skills
  • Good arithmetic skills are required
  • Mechanical aptitude desired
  • Medical device experience is preferred
  • General proficiency of Microsoft Excel and Microsoft Word
  • Contributes to team effort by accomplishing related results as needed.
  • Flexible demeanor and comfortable dealing with uncertainties

Physical Demands

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time.
  • Physical on site presence is required
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SR. MANAGER, QUALITY SYSTEMS & COMPLIANCE

San Jose, California, United States - Full-time
Description
This position is responsible for maintaining and improve compliance to applicable regulatory requirements by maintaining an effective quality management system. The ideal candidate will be primarily responsible for the continuous improvement of Rani quality systems for record management, change control, training, auditing, supplier management, inspection readiness, quality metrics tracking and reporting. This individual works closely with all different functions/departments at Rani to ensure adherence to Rani policies as well as to applicable regulatory requirements.

Requirements

  • Maintain and improve the quality system and provide compliance oversight per FDA 21 CFR part 820, 210, 211, 4 and ISO 13485 requirement
  • Oversee and maintain the deviation, CAPA, change control, training, product complain, investigation and non-conformance programs to ensure compliance with internal SOP and regulatory authority requirements
  • Create and establish the annual internal audit program
  • Trend and report quality metrics for Management Reviews. Implement appropriate enhancements
  • Ensures that performance and quality of products conform to established standards and regulatory agency requirements
  • Review regulatory requirements documents and provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance
  • Implement quality system changes to support evolving regulations and international standards
  • Participate in regulatory authority inspections
  • Lead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA)
  • Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis
  • Manage and trend product complaints
  • Manage supplier qualification program and establish supplier qualification processes, audit plans, quality agreements, quality performance metrics and perform GMP audits to suppliers and service providers
  • Support the organization in maintaining a work environment focused on quality that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Ensure an understanding of the external regulatory requirements, in order to adapt product quality strategy accordingly

Qualifications

  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
  • Flexible and adaptable to changing environment and priorities

Education and/or Job Experience

  • 10+ years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor’s degree in science or related fields
  • Strong knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO)
  • Experience with Quality System Regulation 21 CFR 820 and ISO 13485:2016 Quality Management System
  • Previous experience with combination products is required
  • Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLP
  • Strong knowledge of medical devices, combination products and general pharmaceutical manufacturing
  • Strong project management and process improvement skills
  • Demonstrate keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
  • Experience with Risk Management principles according to ISO 14971
  • Prior people management experience
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization
  • Must demonstrate ability to work independently, make effective decisions
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now

SENIOR EQUIPMENT ENGINEER

San Jose, California, United States - Full-time

Description

Supports the manufacturing of Rani Capsules through design, assembly and integration of new equipment. Works closely with Process Engineering, Manufacturing, Vendors and other teams to define, improve and monitor equipment reliability, throughput and process capability.  Defines, deploys, monitors, and improves the Preventive Maintenance specifications, SPC on key parameters, bill of material and spare parts requirement. Reviews, analyzes, and investigates equipment related scraps and provides root cause analysis and effective corrective actions. Provides technical assistance in installation, preventative maintenance, and calibration of equipment.

Requirements

  • Design and implement equipment upgrade to improve reliability and increase production output.
  • Lead or be an active team member to drive continuous improvement programs to improve equipment performance and reliability, maximize Mean Productive Time Between Failure (MTBF), and Operational Uptime (AOU), and minimize Mean Time To Repair (MTTR).
  • Take ownership of the new equipment specification, technical negotiation with vendors, design and documentation review, installation, and qualification testing and documentation.
  • Ensure project is on schedule, and at the same time deliver with the highest quality by proactively identifying and correcting capability, reliability, and Maintenance issues early on.  Document lessons learned in an efficient manner.
  • Develop preventive maintenance procedures to reduce equipment and tooling failures
  • Generate and maintain accurate and detailed documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
  • Follow SOP on re-validation of existing equipment, tooling and processes
  • Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
  • Support equipment related projects which includes but not limited to:
  • Purchasing of new or used equipment, set-up, qualification, and release in production.
  • Manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing, and set up of new equipment.
  • Integration of different equipment aspects (software and hardware).

Education and Job Experience

  • BS, or MS degree in mechanical engineering, electrical engineering, computer engineering or equivalent
  • 7+ years of experience in Equipment Engineering supporting high volume manufacturing.
  • Good hands-on systems integration experience, troubleshooting, and start-up and commissioning of equipment into production environment.
  • Proficient in Solidworks, Autocad, and GD&T.
  • Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus.
  • Working knowledge of lean manufacturing.
  • Superior communication skills, (written, verbal and active listening.)
  • Highly motivated self-starter, capable of self-management with little to no oversight
  • Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. is a plus.
Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.
Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.
Apply Now
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Benefits

This link leads to the machine readable files that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers. The machine-readable files are formatted to allow researchers, regulators, and application developers to more easily access and analyze data.