Validation Engineer (SAT)
Detroit, Michigan, United States
Job Description
Job Description:
Our client is seeking a Validation Engineer to lead and support Site Acceptance Testing (SAT) activities for equipment being installed at a new manufacturing facility.
Roles & Responsibilities:
Our client is seeking a Validation Engineer to lead and support Site Acceptance Testing (SAT) activities for equipment being installed at a new manufacturing facility.
Roles & Responsibilities:
- The consultant will be responsible for developing and executing test protocols, verifying equipment functionality against User Requirements Specifications (URS) and approved design specifications, documenting test results, troubleshooting deficiencies, and coordinating with Original Equipment Manufacturers (OEMs) to resolve technical issues.
- Equipment may include tanks, pumps, filtration systems, chromatography systems, bioreactors, and other process manufacturing equipment.
- The role will involve working directly with engineering, automation, quality, and vendor teams to confirm equipment is installed, operates as intended, and is ready for subsequent qualification and startup activities.
- A strong validation background is essential, including experience with commissioning and qualification (C&Q), IQ/OQ protocols, GMP documentation, requirements traceability, deviation management, and equipment qualification within pharmaceutical or biotechnology manufacturing environments.
- The ideal candidate will be comfortable reviewing vendor documentation, identifying gaps between design requirements and actual equipment performance, documenting discrepancies, and driving issues through resolution.
- Experience supporting FATs, SATs, risk assessments, and equipment handover into formal qualification is highly desirable.
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Career Focus: Validation
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