CQV Engineer
Source: Arbeitnow
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This role involves developing and executing qualification and validation plans for instruments, utilities, and production lines in GxP environments. Key requirements include a BSc/MSc in a related field, at least 4 years of hands-on CQV experience in GMP-regulated settings, and strong familiarity with EU Annex 15 and FDA 21 CFR 211. The opportunity offers high-visibility projects in the healthcare sector with flexible assignments.
Job Description
Argo-X Argo‑X is a specialist consultancy that delivers flexible, high‑impact staffing to pharma, biotech, medical‑device and diagnostics companies worldwide. Our consultants operate in GxP environments, helping clients accelerate product development while staying fully compliant with evolving regulations. Tasks Develop and execute qualification and validation plans for instruments, utilities, and production lines. Author and review protocols, test scripts, and final reports ensuring traceability and compliance. Perform risk assessments, define acceptance criteria, and manage change control. Support auditors during inspections and provide evidence of validated state. Mentor client staff on best practices and maintain validation documentation libraries. Requirements BSc/MSc in Engineering, Chemistry, Biotechnology or related field. Minimum 4 years of hands‑on CQV experience in GMP‑regulated environments. Strong familiarity with EU Annex 15, FDA 21 CFR 211, and risk‑based validation concepts. Proficient in writing IQ/OQ/PQ protocols, reports, and deviation investigations. Ability to travel to client sites (Europe) and work under tight timelines. Join Us! Why Argo‑X? Join a network where your expertise is matched to high‑visibility projects that shape the future of healthcare. Enjoy flexible assignments, competitive rates, and continuous professional development. Find more English Speaking Jobs in Germany on Arbeitnow
Full Description
Argo-X Argo‑X is a specialist consultancy that delivers flexible, high‑impact staffing to pharma, biotech, medical‑device and diagnostics companies worldwide. Our consultants operate in GxP environments, helping clients accelerate product development while staying fully compliant with evolving regulations. Tasks Develop and execute qualification and validation plans for instruments, utilities, and production lines. Author and review protocols, test scripts, and final reports ensuring traceability and compliance. Perform risk assessments, define acceptance criteria, and manage change control. Support auditors during inspections and provide evidence of validated state. Mentor client staff on best practices and maintain validation documentation libraries. Requirements BSc/MSc in Engineering, Chemistry, Biotechnology or related field. Minimum 4 years of hands‑on CQV experience in GMP‑regulated environments. Strong familiarity with EU Annex 15, FDA 21 CFR 211, and risk‑based validation concepts. Proficient in writing IQ/OQ/PQ protocols, reports, and deviation investigations. Ability to travel to client sites (Europe) and work under tight timelines. Join Us! Why Argo‑X? Join a network where your expertise is matched to high‑visibility projects that shape the future of healthcare. Enjoy flexible assignments, competitive rates, and continuous professional development. Find more English Speaking Jobs in Germany on Arbeitnow