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Senior Process Validation Engineer - GMP/CMO Lead; Remote
Remote / Online - Candidates ideally in
Bedford, Middlesex County, Massachusetts, 01730, USA
Listed on 2026-07-22
Bedford, Middlesex County, Massachusetts, 01730, USA
Listing for:
Stoke Therapeutics
Remote/Work from Home
position Listed on 2026-07-22
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Pharmaceutical
Quality Engineering
Job Description & How to Apply Below
Stoke Therapeutics, headquartered in Bedford, MA, seeks a Senior Engineer/Manager, Process Validation to lead validation activities for DS/DP, labeling, packaging, and shipping across CMOs. The role reports to the Director of Manufacturing Validation and requires collaboration with Manufacturing, QA, Regulatory, and Supply Chain.
Ideal candidates have 8+ years (BS) or 6+ years (MS) in pharma/biotech process validation, with expertise in cGMP, ICH Q8-Q11, and FDA guidelines, plus experience with
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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