Process Validation Specialist

1 week ago


Princeton New Jersey, United States Dr Reddy's Laboratories Limited Full time
Job Overview

We are seeking a Process Validation Specialist to support New Product Launch initiatives. The successful candidate will report to the Head of Technical Services and will operate under a hybrid work model.

Key Responsibilities


1. Manage process validation activities (PPQ) and deliver life cycle management assistance for a variety of products and technologies across both internal and external manufacturing networks.


2. Design, plan, and implement process development and optimization studies, as well as technology transfers for new business ventures within the North American manufacturing landscape.


3. Provide expert guidance in troubleshooting product and process technical challenges, including conducting manufacturing investigations and addressing CAPAs.


4. Author, review, and execute cGMP documentation, which encompasses validation protocols and reports, SOPs, batch records, and change controls, among other critical documents.


5. Conduct statistical evaluations for process validation and control.


Training and Development


6. Train staff and develop procedures for new equipment and processes.


7. Identify and explore opportunities for process enhancements.


Technical Expertise


8. Act as the technical authority for various processes and equipment.


9. Conduct technical due diligence of manufacturing facilities to support product outsourcing and the selection of Contract Manufacturing Organizations (CMOs) for new product development and manufacturing.



  • Princeton, New Jersey, United States Dr Reddy's Laboratories Limited Full time

    Job OverviewCompany OverviewAt Dr. Reddy's, we are committed to transforming healthcare by providing innovative solutions that improve the quality of life for patients. Our mission is to ensure that good health is accessible to all, and we are dedicated to fostering a diverse and inclusive workplace where every employee can thrive.Position SummaryWe are in...


  • Princeton, New Jersey, United States Dr Reddy's Laboratories Limited Full time

    Job OverviewCompany OverviewAt Dr. Reddy's, we are dedicated to transforming healthcare by making innovative medicines accessible to all. Our mission is to enhance the quality of life for patients around the globe through groundbreaking research and development.Commitment to DiversityWe value diversity, equity, and inclusion, striving to create a workplace...


  • Princeton, New Jersey, United States Dr Reddy's Laboratories Limited Full time

    Job OverviewCompany OverviewAt Dr. Reddy's, we are committed to transforming healthcare by making essential medicines accessible and innovating treatment solutions to meet unmet medical needs. Our mission is to empower individuals to lead healthier lives, and we are looking for passionate and motivated professionals to help us achieve this goal.Commitment to...


  • New York, New York, United States Medix™ Full time

    Cleaning Validation EngineerLocation: Rensselaer, NYShift: Saturday-Wednesday OR Sunday-Wednesday, 10AM-8PMPay: $55-85/HR, based on experienceDuration: 3-5 Year CONTRACT with benefitsMedix™ is seeking skilled Cleaning Validation Engineers to enhance our operations at the Rensselaer facility. This position is crucial for executing cleaning validation tasks...


  • New York, New York, United States EPM Scientific Full time

    We are seeking a highly skilled Computer System Validation (CSV) Specialist to support our pharmaceutical client with an uplift in work. This is a contract role that offers an opportunity to contribute to critical CSV activities within a regulated, GxP-compliant environment.**Key Responsibilities:**Lead and execute Computer System Validation (CSV)...


  • New York, New York, United States Katalyst Healthcares and Life Sciences Full time

    Job SummaryKatalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the accuracy and reliability of our equipment and processes.Key ResponsibilitiesQualification and Validation: Collaborate with cross-functional teams to...


  • New Brunswick, New Jersey, United States Sun Pharmaceutical Industries Full time

    Job SummaryThe Validation Specialist is responsible for ensuring the quality and compliance of equipment and processes in a pharmaceutical manufacturing environment. This role requires a strong understanding of cGMP regulations and the ability to develop and implement validation plans.Key ResponsibilitiesDevelop and execute URS, IQ/OQ/PQ protocols and write...


  • New York, New York, United States Medix™ Full time

    Cleaning Validation EngineerLocation: Rensselaer, NYShift: Saturday-Wednesday OR Sunday-Wednesday, 10AM-8PMPay: $55-85/HR, based on experienceDuration: 3-5 Year CONTRACT with benefitsMedix™ is seeking experienced Cleaning Validation Engineers to enhance our operations. This position involves the practical execution of cleaning validation tasks within a...


  • New Brunswick, New Jersey, United States Sun Pharmaceutical Industries Full time

    Job Title: Validation SpecialistJob Summary:The Validation Specialist is responsible for ensuring the quality and compliance of equipment, packaging, and utilities in a pharmaceutical manufacturing environment. This role requires a strong understanding of regulatory requirements and the ability to develop and execute validation protocols.Key...


  • Hightstown, New Jersey, United States Empower Pharmacy Full time

    Position Overview:The Process Automation Specialist plays a crucial role in enhancing the efficiency, reliability, and innovation of Empower Pharmacy's manufacturing processes. This position is vital for the upkeep and troubleshooting of sophisticated automation control systems, which are essential for our commitment to delivering high-quality pharmaceutical...

  • Validation Engineer

    3 months ago


    New Jersey, United States LS Solutions Inc. Full time

    Key Responsibilities Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry. Required Bachelor's degree in pharmaceutical Science OR related field of study. Schedule and plan equipment and process qualification workload to meet approved schedules. Handle multiple projects and be able to work independently as required....


  • Princeton, New Jersey, United States Lumicity Full time

    Senior Process Engineering Specialist - Material Innovation - AI IntegrationWe are seeking a Senior Process Engineering Specialist to take charge of the innovative design and modeling of advanced chemical processes.This role is pivotal in driving innovation in the development, synthesis, and commercialization of cutting-edge materials and chemical processes...


  • Somerset, New Jersey, United States IPS-Integrated Project Services Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Validation Consultant to join our team at IPS-Integrated Project Services. As a Senior Validation Consultant, you will play a critical role in ensuring the delivery of high-quality validation services to our clients in the biotechnology and pharmaceutical industries.Key...


  • Princeton, United States Catapult Full time

    Job DescriptionJob DescriptionThe Senior Validation Manager is leading the site validation program and all qualification and validation activities at the Erytech, Princeton site, NJ. Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic...


  • Atlantic City, New Jersey, United States Ocean Casino Resort Full time

    About the PositionThe Cash Processing Specialist is tasked with the precise handling and counting of cash, chips, and tickets from all gaming tables and slot machines.Key Responsibilities- Remove bill validator drop boxes from slot machines and replace them with empty boxes.- Load the collected bill validator boxes onto a cart and transport them to the...


  • New York, New York, United States GEA Process Engineering Full time

    Job DescriptionAs a Warehouse Process Analyst at GEA Process Engineering, you will play a crucial role in optimizing our warehouse operations to increase efficiency, reduce costs, and enhance overall operational performance.Key Responsibilities:Analyze and Improve Warehouse Processes: Identify inefficiencies, bottlenecks, or areas for improvement in...


  • Princeton Junction, United States International Process Plants Full time

    Position Overview:We are seeking a technically curious, hands-on Asset Management Specialist. The candidate will conduct equipment and plant inspections, manage equipment documentation, and support sales teams with technical knowledge. This role is ideal for a former Plant Maintenance or Operations Manager who understands process equipment, flow diagrams,...


  • Princeton, New Jersey, United States TMS LLC Full time

    Position: Configuration Management SpecialistLocation: RemoteContract Duration: 3-6 MonthsExperience Required: 7-8 YearsImportant Note: Candidates should possess experience in environments related to Production Support, particularly with ETL Suites and Control Monitoring.Job Overview:We are seeking a Configuration Management Specialist to develop and execute...


  • Paterson, New Jersey, United States St. Joseph?s Health Full time

    Position Summary:St. Joseph's Health is esteemed for the proficiency and empathy of its dedicated and skilled personnel. The collaborative efforts of our exceptional physicians, outstanding nursing staff, and committed clinical and administrative teams have established us as one of the most reputable healthcare institutions in the region, recognized as a...


  • Albany, New York, United States Zifo Full time

    About the RoleZifo is seeking a skilled Validation Analyst to join our team in Albany, NY. As a key member of our laboratory IT team, you will be responsible for supporting the lifecycle of documents and execution, authoring validation lifecycle documents, and executing approved protocols.ResponsibilitiesSupport the development and execution of laboratory IT...