Sr Manufacturing Engineer
Katalyst CRO · Manchester, NH · 1 wk ago
HybridEngineeringContract
Roles & Responsibilities
- Revising and maintaining manufacturing documentation, including work instructions, SOPs, and process documentation, ensuring accuracy, compliance, and alignment with current production practices.
- 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.
- Supporting process validation activities (IQ, OQ, PQ).
- Contributing 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.