KH
Sr Manufacturing Engineer
Katalyst Healthcares & Life Sciences
🇬🇧 United Kingdom | 🇺🇸 United States
Hybrid
Senior
3 months ago
- Risk Management
- PFMEA
3 months ago
Not enough detail in this posting to match
- Our client is seeking a Senior Manufacturing Engineer to support manufacturing operations through process improvement, technical documentation, and risk management activities within a regulated production environment.
- This role will focus heavily on revising and maintaining manufacturing documentation, including work instructions, standard operating procedures (SOPs), and process documentation, ensuring accuracy, compliance, and alignment with current production practices.
- The engineer will play a key role in identifying and managing operational risks through structured risk management methodologies such as PFMEA and DFMEA, with a strong emphasis on defining and analyzing critical process inputs and outputs to support robust process controls.
- In addition to core manufacturing engineering responsibilities, the role will support process validation activities (IQ, OQ, PQ) and contribute to cross-functional efforts related to operational risk assessments and TMVS documentation.
- Experience with CSV is considered a plus. The ideal candidate will bring strong analytical and documentation skills, along with experience supporting regulated manufacturing environments where process integrity and traceability are critical.
- Exposure to high-volume bottling or filling equipment is highly desirable, though not required, and candidates with experience supporting automated or high-throughput production lines.
Sr Manufacturing Engineer · Katalyst Healthcares & Life Sciences