Job Description

Technical Source is seeking Validation Engineers to support drug substance manufacturing and CQV (Commissioning, Qualification, and Validation) projects for pharmaceutical and biotechnology clients. The ideal candidate will bring a blend of hands-on validation expertise, documentation expertise, and experience working within other regulated manufacturing environments

Responsibilities:

• 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

Preferred 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