CQV Engineer

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.