Join to apply for the Sr Process Validation Engineer role at Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the Sr Process Validation Engineer role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in accordance with ISO 14971 and relevant quality standards. Analyse and interpret process data to ensure processes are capable, controlled, and repeatable. Ensure traceability, documentation, and regulatory compliance throughout validation life cycle. Collaborate with R&D and Manufacturing teams to develop and optimize manufacturing processes for scale-up from laboratory to production scale. Design and conduct feasibility studies, process capability studies, and pilot runs. Support selection, specification, and commissioning of new equipment for laboratory and manufacturing environments. Provide technical input on design for manufacturability and process improvements.

Responsibilities

Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in accordance with ISO 14971 and relevant quality standards. Analyse and interpret process data to ensure processes are capable, controlled, and repeatable. Ensure traceability, documentation, and regulatory compliance throughout validation life cycle. Collaborate with R&D and Manufacturing teams to develop and optimize manufacturing processes for scale-up from laboratory to production scale. Design and conduct feasibility studies, process capability studies, and pilot runs. Support selection, specification, and commissioning of new equipment for laboratory and manufacturing environments. Provide technical input on design for manufacturability and process improvements.

Requirements:

Bachelors in chemical engineering. 5+ years of experience in process validation and development within the medical device, biotech, or other relevant regulated industry. Experience with lyophilization, liquid mixing, and bioabsorbable material handling. Proficiency with pFMEA and process risk management tools. Excellent technical writing, documentation, and communication skills. Experience with synthetic biomaterials or orthopaedics products. Familiarity with scale-up of lab-based processes to manufacturing environments. Lean Six Sigma or validation certification (e.g., ASQ, PDA). Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Senior Validation Engineer jobs in Franklin Lakes, NJ . New York, NY $145,000.00-$165,000.00 1 week ago Senior Quality Engineer (Wayne, NJ) Defined Term Wayne, NJ $100,000.00-$115,000.00 2 weeks ago New York, NY $140,000.00-$170,000.00 5 days ago New York City Metropolitan Area 2 days ago Staff Quality Data Engineer - Diagnostics and Telemetry Secaucus, NJ $87,520.00-$131,280.00 2 days ago Third Party Risk Management Validation Manager Jersey City, NJ $81,000.00-$250,000.00 1 week ago Audit Manager II - Financial Crimes- Regulatory Validation Sr. Mechanical Engineer (Must Have Test Method Development, Verification, Medical Device) Sr Audit Manager Financial Crimes - Issue Validation New York City Metropolitan Area $90.00-$100.00 1 week ago Senior Robotics Software Engineer (ROS2 / PLC / CV) New York City Metropolitan Area 2 weeks ago Whippany, NJ $209,639.00-$225,161.00 2 weeks ago Whippany, NJ $209,639.00-$225,161.00 2 weeks ago Senior Engineer Identity & Access Management Parsippany, NJ $115,000.00-$155,000.00 44 minutes ago Whippany, NJ $223,000.00-$230,000.00 2 days ago Whippany, NJ $223,000.00-$230,000.00 2 days ago Whippany, NJ $165,000.00-$227,000.00 1 day ago Morris Plains, NJ $120,000.00-$125,000.00 1 week ago React.JS Software Engineer (Senior Full Stack React.JS Developer) Senior Software Engineering Lead - Private Equity & Real Estate Technology New York, NY $175,000.00-$235,000.00 2 weeks ago Vice President, Senior Software Engineer - Capital Markets New York, NY $166,000.00-$205,000.00 2 weeks ago Senior Engineer II - Microsoft Copilot & Power Platform Solutions Front-End Designer & Animator, Senior Associate Senior Engineer Quality Operations (Wayne, NJ) Wayne, NJ $100,000.00-$115,000.00 1 week ago New York, NY $150,000.00-$165,000.00 6 days ago Sr. Engineer, Validation and Reliability Fairfield, NJ $100,000.00-$110,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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