Description
The Process Validation Engineer will support cross-functional process validation strategies, author and execute PV protocols and regulatory deliverables, perform compliance and data-integrity checks, maintain validation schedules and submission filings, assist with product introductions and process transfers, facilitate cross-functional review workflows, use digital quality systems, and support root-cause investigations and CAPAs. The role also provides hands-on exposure to equipment qualifications and cleaning validation studies. It requires a bachelor’s degree with 4–6 years of relevant experience or a master’s degree with 2–4 years of experience, along with cGMP biopharmaceutical manufacturing experience. The position involves a mix of office and cGMP cleanroom work, with a California salary range of $80,500 to $149,500.
