Sr Manufacturing Engineer

Katalyst Healthcares and Life Sciences

United States

Roles & Responsibilities:

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.

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Vacancy posted 3 days ago

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