Katalyst Healthcares and Life Sciences
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.
- 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).