CQV Engineer

argo Experts; Konstanz; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Argo-X in Konstanz, Germany, seeks an experienced CQV engineer to develop and execute qualification and validation plans for instruments, utilities, and production lines in GMP-regulated environments.

You will author and review IQ/OQ/PQ protocols, perform risk assessments, support audits, and mentor client staff while travel across Europe is required.

Qualifikationen

• Minimum 4 years of hands-on CQV experience in GMP-regulated environments.
• Strong familiarity with EU Annex15, FDA 21CFR211, 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.

Aufgaben

• 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.

Kenntnisse

CQV experience

GMP familiarity

EU Annex15

FDA 21 CFR 211

IQ/OQ/PQ protocols

Ausbildung

BSc/MSc in Engineering, Chemistry, Biotechnology or related field

Jobbeschreibung

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 4years of hands-on CQV experience in GMP-regulated environments.
• Strong familiarity with EU Annex15, FDA 21CFR211, 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.