Validation Engineer (SAT)

About the role

Lead and support Site Acceptance Testing (SAT) activities for equipment being installed at a new manufacturing facility.

The role focuses on equipment in a pharmaceutical or biotechnology manufacturing environment.

Tasks

• Develop and execute Site Acceptance Testing (#SAT) protocols for process manufacturing equipment.
• Verify equipment functionality against User Requirements Specifications (URS) and approved design specifications.
• Document test results, identify discrepancies, troubleshoot deficiencies, and coordinate corrective actions.
• Collaborate with Original Equipment Manufacturers (#OEMs) to resolve equipment performance and technical issues.

Requirements

• Strong validation experience in pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Hands-on experience developing and executing #SAT protocols.
• Knowledge of commissioning and qualification (#C&Q), #IQ/OQ protocols, and equipment qualification.
• Experience verifying equipment against #URS and approved design specifications.
• Understanding of #GMP documentation, requirements traceability, risk assessments, and deviation management.
• Preferred: Experience supporting Factory Acceptance Testing (#FAT) and Site Acceptance Testing (#SAT).
• Preferred: Experience with process manufacturing equipment, including tanks, pumps, filtration systems, chromatography systems, and bioreactors.
• Preferred: Experience coordinating with #OEMs, equipment vendors, Engineering, Automation, and Quality teams.

How to apply

• Connect with us or send your resume by email.

Location

• #Detroit, MI, Katalyst Pro