Sr Process Validation Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Franklin Lakes, NJ, 07417

Posted Date : 3 October 2025

Job Type : Other

Category : Mechanical Engineering

Occupation : Validation Engineer

Job Details

Responsibilities:

uthor 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.
nalyse 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).