Validation Engineer (SAT)

About the role

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.

Responsibilities

• Develop and execute test protocols
• Verify equipment functionality against User Requirements Specifications (URS) and approved design specifications
• Document test results
• Troubleshoot deficiencies
• Coordinate with Original Equipment Manufacturers (OEMs) to resolve technical issues
• Work with tanks, pumps, filtration systems, chromatography systems, bioreactors, and other process manufacturing equipment
• Collaborate with engineering, automation, quality, and vendor teams to confirm equipment is installed, operates as intended, and is ready for subsequent qualification and startup activities

Requirements

• Strong validation background, 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
• 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