5-7 years of experience in validation engineering within pharmaceutical or biotechnology sectors.
Strong background in commissioning and qualification (C&Q) processes.
Proficient in developing IQ/OQ protocols and GMP documentation.
Experience with requirements traceability and deviation management.
Ability to review vendor documentation and identify performance gaps.
Responsibilities
Develop and execute test protocols for Site Acceptance Testing (SAT).
Verify equipment functionality against User Requirements Specifications (URS).
Document test results and troubleshoot deficiencies.
Coordinate with Original Equipment Manufacturers (OEMs) to resolve technical issues.
Collaborate with engineering, automation, quality, and vendor teams to ensure proper equipment installation and operation.
Support equipment handover into formal qualification processes.
Benefits
Opportunity to work on cutting-edge manufacturing equipment.
Engagement with cross-functional teams in a dynamic environment.
Chance to influence equipment readiness for qualification and startup activities.
Full 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:
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.
