Qualification Engineer

6 Month Contract With Extensions Germany On Site Fully 100% Great Tax Net Retention - Very Attractive Start ASAP Feb/March Must have EU Passport

Key Responsibilities

1. Commissioning & Qualification Execute commissioning activities for new and modified pharmaceutical equipment. Develop, review, and execute IQ and OQ protocols. Document and resolve deviations encountered during qualification activities. Ensure traceability between requirements, testing, and acceptance criteria. Support Performance Qualification (PQ) activities as required.

2. FAT / SAT Execution Participate in Factory Acceptance Testing (FAT) at vendor sites. Support Site Acceptance Testing (SAT) upon equipment installation. Verify equipment functionality against URS, FRS, and design specifications. Document punch list items and ensure closure prior to qualification. 3. Alarm Testing & Control Systems Verification Execute alarm verification and challenge testing. Verify alarm setpoints, interlocks, and system responses. Confirm compliance with data integrity requirements (e.g., audit trails, user access levels). Coordinate with automation and engineering teams for troubleshooting.

4. Documentation & Compliance Author and review: Commissioning plans IQ/OQ protocols and reports Traceability matrices Risk assessments (e.g., FMEA)