Careers

We are seeking an exceptional Senior Mechanical Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, disposable devices.  Your role is to find creative and sound engineering solutions to challenging problems with a 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, Biology, Quality, Facilities, and Sustaining.

Requirements

• Develop concepts and ideas for improving existing tooling as well as creating new tooling including semi-automation where applicable
• Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators
• 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
• Create 3D models, engineering drawings and bills of materials
• Create comprehensive work instructions and manufacturing SOP’s
• Create verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reports
• Participate in design FMEA and plan steps for mitigating risks
• Establish a working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
• Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

• Bachelor’s Degree in Mechanical Engineering
• 5-7 years hands-on, relevant experience
• In-depth experience with complex mechanical/electromechanical design
• Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
• Experience with creating engineering drawings, BOMs and product specifications
• Deep knowledge of material properties, heat treatment, and surface finish
• Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and 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
• Deep knowledge of GD&T as well as proficiency with SolidWorks
• 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 Mechanical Engineering or equivalent
• 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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

The Sr. Quality Assurance Engineer supports the Design and Development group to ensure devices, components, and materials in development comply with Rani SOP’s and applicable regulatory requirements. The ideal candidate will have working knowledge in the design control requirements for medical device and hands-on experience in product life cycle, from feasibility prototype through product commercialization. The Sr. QE will provide quality and compliance input to the project team for project decisions and deliverables (e.g., Product Specifications, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.

Requirements

• This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
• Provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles
• Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations
• Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.)
• Lead test method validation activities and Gage R&R studies for Combination Product
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification
• Identify quality characteristics and validation criteria for components, subassemblies, and finished product
• Work with R&D in the creation of requirements for new products and engineering specifications
• Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
• Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of Design Controls
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports
• Support quality assurance activities, including, but not limited to: internal and external audits, NCMRs and CAPAs,
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

• A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required
• BS degree in Mechanical Engineering or related field is required
• Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485
• Experience with Risk Management process (Risk Management Plan/Report, FMEA’s) and associated standards (ISO 14971:2019)
• Understanding of multiple technology areas (software, mechanical, electrical, biomedical, test automation, etc.)
• Must be a self-starter and capable of working independently and within a team.
• Experience performing statistical analysis (Six Sigma preferred)
• CQE, CQA preferred

Skills and Specifications

• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail 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; write reports
• Ability to create and provide training
• Good statistical and numerical ability
• Exceptional problem-solving skills
• Understands and can subsequently explain complex quality details to non-experts

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

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, design, install, commission, start-up as well as maintain and improve the liquid, powder, and aseptic process and equipment.
• Responsible for the process improvements in the areas of material handling, ingredients preparation, liquid & powder process and aseptic process.
• Ensures compliance of process parameters and operational conditions with cGMP and other FDA regulations.
• As subject matter expert, provide technical leadership in the areas of liquid & powder process, and aseptic operations.
• Authors and reviews documents including Preventive Maintenance plans, Standard Operating Procedures, Batch Records, Material specifications, and other forms.
• Author and review validation and change control documents such as master plans, validation protocols, summary reports and change requests
• Develop project justification and engineering proposals for capital equipment purchasing and upgrades.
• Proficient on problem solving methodologies (DMAIC, 8D, etc.)
• Proficient skills in troubleshooting mechanical, process, and automation related issues.
• Utilizes the process to analyze available data, plan, design, and implement the best value options that result in low cost/high efficiency and renovation/innovation improvements (including the development and organization of necessary systems).
• Coordinates with the Business Unit, Engineering, Maintenance, and others as necessary to provide information regarding necessary improvements to equipment / processes in order to reach targets.
• Participates in budget preparation and capital expenditure recommendations.
• Acts as Subject Matter Expert to provide assistance as necessary to the Supervisors and Training Coordinators in order for the coordinators to provide appropriate training to employees entering the department or as needed for process changes.
• 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)
• Develop improvements to enhance equipment reliability and scalability
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• 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
• Complete projects, report status, and document lessons learned in an efficient manner

Education and/or Job Experience

• • BS in Chemical Engineering, Industrial/Manufacturing Engineering, or similar related field
  • 5+ years of engineering experience in Aseptic Processing, Medical Device 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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

(9:30AM – 6:00PM mid-shift/ Monday thru Friday)

The Quality Inspector is responsible for supporting all receiving inspection activities, including all aspects of inspection (receiving, first article inspection and in-process). Perform visual and dimensional inspections as defined by our Standard Operating Procedures and Engineering Drawings. This position will be required to determine accept / reject disposition based on inspection results. As the Quality Inspector, you will support the Development and Production/Manufacturing departments with inspections of materials/parts/products, while maintaining compliance with Quality Management System (QMS) procedures.

Requirements

• Perform inspection of parts/materials received, in-process, and finished products for conformance to specifications and in accordance to QMS procedures
• Perform inspection using a variety of standard metrology equipment, including: Micro-Vu, height gauge, pin gauges, calipers, micrometers, surface table, gauge blocks, dial indicators, durometer, etc.
• Read engineering drawings and interpret geometric dimensioning and tolerance, be able to perform inspection with minimal supervision
• Determine inspection sample size based on procedures, specifications, and standards.
• Perform analysis per the established procedures/specifications to make pass/fail decisions
• Document inspection activities in accordance to quality procedures and Good Documentation Practices
• Maintain accurate records as per Document Control procedures
• Report discrepancies and issues to QA Lead and affected function(s)
• Initiate NCMRs when failed results are obtained or discrepancies are observed during the inspection process
• Assign and apply expiration dating labels to materials/parts, as per the specifications/quality procedures
• Interact closely with different functions of the organization
• Assist in the development of inspection methods to support products under development
• Performs other duties as needed to support the Quality Assurance Department and the company

Education and/or Job Experience

• Minimum of 3 years of experience performing inspections
• Micro Vu or similar CMM experience is required
• Experience with AQL Sampling using C=0 Sampling PlanKnowledge and use of precision testing equipment and tools
• Government Regulated Environment experience such as FDA and ISO
• Must have adequate computer experience (knowledge of Microsoft Word, Excel)Experience working in a cGMP environment

Skills and Specifications

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Micro vu, Microvu, Micro-vu experience. And did we mention that a great candidate would have Micro vu experience?

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

The Validation Engineer II will work with the Quality, Engineering and Manufacturing teams in supporting our validations efforts in the introduction of a new combination product. The ideal candidate will have working knowledge in the System Life Cycle and hands-on experience in all type of validation deliverables (VP, SIA, RS, DS, CS, Periodic Review), and validation executions. The Validation Engineer II will provide quality and compliance input to the project team for validation project decisions The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.

Major Duties and Responsibilities

•  Create, review, and execute qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances/deviations.
• Develop validation documents with functional teams, ensuring the documentation meets regulatory requirements and quality standards.
• Collaborate with project stakeholders, engineers, SMEs, information systems teams, and others to develop requirements (RS, DS, CS), related technical specifications, and other associated documentation.
• Initiate, process, and manage change control requests.
• Translate system requirement specifications into executable validation protocols.
• Provide equipment, system, software, and Laboratory equipment qualification guidance and strategy during project planning and development phases.
• Manage contractors performing equipment and system qualifications, when required.
• Report status and progress of qualification activities or projects to the Leadership team.
• Support the execution of engineering projects.
• Initiate/update GxP and Risk Assessments on system.
• Author, Review and or approve scheduled periodic reviews.
• Author, Initiate, and/or review and approve SOPs related to validation & compliance.
• Other duties as assigned.

Education and/or Job Experience

• BS degree in Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biotechnology or Life Sciences, Computer Science, IT or any other variety of engineering/technology education with 6 years of experience in computer system Compliance and/or Validation. MA/MS degree can be substituted with 3 years of experience.
• 6+ years’ experience in FDA regulated environment with strong understanding of cGxP standards and Risk based validation.
• Knowledge of FDA guidance’s and industry standards (i.e., Quality Systems, GAMP, 21 CFR Part 11). 2 of 2
• Experience in developing or reviewing Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices, and Validation Summary Reports.
• Read and interpret drawings such as PFDs, P&IDs and electrical schematics is preferred.
• Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; utility and facility validation experience is preferred; process validation experience is a plus.
• Previous experience with Analytical and Manufacturing systems as a Business Analyst is a plus.
• Knowledge of pharmaceutical manufacturing of products, aseptic processing, and process development is a plus.
• Working knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals, and medical devices.
• Understanding of multiple technology areas (software, mechanical, electrical, biomedical, test automation, etc.)

Skills and Specification

•  Must be a self-starter and capable of working independently and within a team.
• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail organizing, planning, and problem solving skills
• Good interpersonal and communication skills
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Exceptional problem-solving skills
• Understands and can subsequently explain complex quality details to non-experts
• Ability to function efficiently and independently in a fast paced, changing environment.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills and fluent with Microsoft office applications.
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

This position is responsible for support and administration of Quality Systems and Compliance tasks in support of Good Manufacturing Practices (GMP) programs. The ideal candidate’s primary responsibility will be the administration of Rani quality systems for 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.

Major Duties and Responsibilities

• Support Rani’s change control management system
• Support the sites ISO 13485 certification program
• Write, revise QA Policies, Standard Operating Procedures, WIs, as applicable
• Contribute and prepare training and education programs for various aspects of the quality system
• Administer the training Program in compliance with cGMP for drugs and combination product
• Maintain and support the deviation, CAPA, change control, training, product complain, investigation and non-conformance and risk management programs to ensure compliance with internal SOP and industry requirements
• Support and track the annual internal audit program
• Trend and report quality metrics for Management Reviews
• Maintain Quality Dashboard
• Review regulatory requirements, documents and provide guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance
• Participate in regulatory authority inspections
• Perform internal quality audits
• Support/coordinate investigations, development and implementation of corrective and preventative action (CAPA)
• Lead CAPA Review Board
• Work extensively with Operation entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis
• Support the investigation, analysis and trend of product complaints
• Support external regulatory agency audits/inspections
• Support supplier qualification program and 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
• Other duties as assigned

Education and/or Job Experience

• 5+ 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 part 4, 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO)
• Minimum 3 years’ experience required with Quality System Regulation 21 CFR 820 and ISO 13485:2016 Quality Management System
• Previous experience with combination products is desired
• Must be familiar with: FDA pharma cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLP
• Knowledge of medical device, combination products and pharmaceutical manufacturing
• 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 and ICH Q9 desired
• 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

Skills and Specifications

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

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

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 primary responsibility 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.

Major Duties and Responsibilities

• Maintain and improve the quality system and provide compliance oversight per FDA 21 CFR part 4, 820, 210, 211, and ISO 13485 requirements
• Lead and manage the sites ISO 13485 certification program
• Write, revise QA Policies, Standard Operating Procedures, as applicable
• Management of Training Program in compliance with cGMP for drugs and combination product standards
• Oversee and maintain the deviation, CAPA, change control, training, product complain, investigation and non-conformance and risk management 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.
• 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

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 and ICH Q9
• 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

Skills and Specifications

• 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

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

The Quality Control (QC) Technician will be responsible for contamination control and product testing activities in adherence to FDA, EMEA regulations. This role will be integral to Rani’s product release performing key functions on environmental monitoring, investigation, excursion report, writing and interacting with Contract Testing Laboratories. The QC technician will use the Corrective and Preventive Actions (CAPAs) system to identify and investigate issues that may arise during the manufacturing process.

This position is responsible for maintaining accurate and up-to-date records of all quality control testing related activities. Documentation plays a crucial role in ensuring that products meet regulatory and quality standards, and quality technicians must ensure that all documentation is complete, accurate, and accessible.

Major Duties and Responsibilities

• Perform environmental monitoring of clean room(s), isolator(s) and ISO 5 equipment
• Sample management of environmental samples, product release testing and stability testing
• Implement QC testing methods for environmental monitoring, medium growth promotion, sterility testing, endotoxin testing, TOC etc.
• Responsible for Environmental monitoring equipment maintenance and oversight
• Perform visual inspection testing of product intermediates and final product per USP<1>
• Execute cleaning validation studies, for example swab recovery studies
• Execute equipment, process or method validation protocols
• Purchasing of lab equipment, consumables
• Writing URS for equipment
• Shipping of samples to external testing laboratories
• Capable of performing reviews/approvals of Quality records
• Capable of releasing materials/product to inventory
• Inventory management of microbiological media and consumables
• Coordination and performance of microbial isolation and identification
• Able to write and revise SOP’s
• Submit change orders and represent QA in meetings for related projects
• Assist on NCMRs, deviations, and CAPA investigations
• Assist on quality audits
• Able to assist in validations
• Assist in implementing and trending of qualify metrics
• Work with Engineering/Quality Engineering on the development of inspection methods/programs
• Supports quality assurance engineering with technical support in issues affecting manufacturing or QMS
• Communicate effectively and thoroughly to management and peers

Education and/or Job Experience

• 5+ years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor’s degree in science or related fields
• Minimum 2 years of cleanroom environmental monitoring sampling and testing program experience
• Minimum 2 years of Quality Control testing in a regulated manufacturing environment
• Minimum 3 years of cGMP experience in a testing lab in compliance with 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
• Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLP
• Excellent verbal, written, interpersonal, organizational, and communication skills are necessary

Skills and Specifications

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Capable of training others
• 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

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.

Our organization’s commitment to Diversity, Equity, and Inclusion is key to making us a better team – one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we’re committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.