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:
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.
Numbers & Facts
Location
Detroit, MI
Skills
Acceptance Testingunmatched
Automationunmatched
Biotech and Pharmaceuticalunmatched
Chromatographic Systemsunmatched
Commissioningunmatched
Consultingunmatched
Documentationunmatched
Drug Manufacturingunmatched
Functional Testingunmatched
GMP (Good Manufacturing Practices)unmatched
Manufacturingunmatched
Manufacturing Equipmentunmatched
OEM (Original Equipment Manufacturer)unmatched
Problem Solving Skillsunmatched
Process Manufacturingunmatched
Process Validationunmatched
Pumpsunmatched
Requirements Managementunmatched
Risk Analysisunmatched
Startupunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Traceabilityunmatched
Vendor/Supplier Selectionunmatched
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