Process Engineer

New

Skills

Chemical Engineering Cross-functional teamwork Technical Writing

Lead DS manufacturing tech transfer and support GMP ops. Develop quality-engineering methodologies meeting regulatory requirements. Support manufacturing and CapEx programs including upgrades. Revise batch records and SOPs; maintain Quality System. Write protocols/reports; contribute to regulatory filings. Collaborate with cross-functional teams to support product development.

Key Responsibilities

Lead DS manufacturing tech transfer and support GMP ops
Develop quality-engineering methodologies meeting regulatory requirements
Support manufacturing and CapEx programs including upgrades

Required Skills & Qualifications

7+ years GMP manufacturing, process development, or engineering
Experience with bioprocesses such as fermentors/bioreactors, TFF, and chromatography
Aseptic filling and biosafety cabinets; QA documentation

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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