CQV Engineer

argo ExpertsKonstanzfull-time

AI Summary: CQV (Commissioning, Qualification, and Validation) engineer responsible for developing validation protocols, executing qualification plans for pharma/biotech equipment and production lines, and ensuring regulatory compliance through testing and documentation. Day-to-day involves writing protocols, performing risk assessments, managing compliance evidence, and supporting regulatory audits.

Career-change fit:7/10

QA & TestingFlexible Hours

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Originally posted onarbeitnow on 3/16/2026

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.

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