Pharmaceutical Validation Engineer
$104,000–$124,800 year
On-site · Raleigh, North Carolina, United States
Raleigh, North Carolina, United StatesOn-siteFull Time$104,000–$124,800 yearMid LevelNot SpecifiedUnknown
Type
Full Time
Level
Mid Level
Education
Not Specified
Company size
Unknown
Job Summary
Develop and execute IQ/OQ/PQ protocols for critical manufacturing equipment and utilities; author and manage validation documentation; interface with QA, engineering, manufacturing, and automation teams throughout project lifecycles; assist in tech transfer and startup support for drug substance or biologics facilities; support commissioning and qualification of new or renovated GMP areas.
Required Qualifications
- 3-7+ years of validation experience in pharmaceutical or biotech manufacturing
- Experience in drug substance environments (e.g., bioreactors, fermenters, chromatography skids, buffer/media prep tanks, CIP/SIP systems)
- Previous CQV experience in large capital projects, greenfield/brownfield preferred
- Strong GMP compliance knowledge; experience with FDA, EMA inspections a plus
- Excellent communication, technical writing, and cross-functional collaboration skills
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