Sr Process Validation Engineer
Sr Process Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- 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.
- 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).
Employment Type
Full Time