CQV Lead Engineer – GMP Biopharma Projects

Adryan B.V; Netherlands; Remote; EUR 90.000 - 120.000; Teilzeit

Zusammenfassung

Adryan B.V. is recruiting a CQV manager for the Dutch life sciences market. The role involves leading commissioning, qualification and validation activities for GMP facilities and utility systems within the client’s site and ensuring regulatory compliance.

You will design and execute IQ, OQ, PQ protocols, analyse data, resolve issues, and drive documentation workflows. A Bachelor’s degree and 5+ years GMP experience with CQV are required; 3+ years CQV is preferred for this leadership position.

Qualifikationen

• Bachelor’s degree in engineering, science or related field.
• Proficient with MS Office; strong document/data management.
• In-depth knowledge of cGMP regulations and process validation.
• 5+ years in a GMP environment, preferably biotech.
• 3+ years of CQV experience.
• Strong teamwork, communication and problem-solving mindset.

Aufgaben

• Accountable for all CQV activities as required by schedule and timelines.
• Provide support in a timely, efficient and quality manner.
• Design, develop, execute, write and archive C&Q documentation (IQ/OQ/PQ) and validation protocols.
• Analyse and report validation data and findings in final reports.
• Identify GMP requirements for validation from design.
• Resolve protocol/execution discrepancies and plan follow-up actions.
• Make recommendations on test strategies and approaches.
• Conduct and coordinate validation testing.
• Maintain good contact with team members and troubleshoot.

Kenntnisse

CQV

Process validation

cGMP knowledge

GMP experience

Problem solving

Communication skills

Team player

Ausbildung

Bachelor’s degree in engineering

HTS in chemical or mechanical engineering

Tools

MS Office

Jobbeschreibung

Adryan B.V. is recruiting a CQV manager for the Dutch life sciences market. The role involves leading commissioning, qualification and validation activities for GMP facilities and utility systems within the client’s site and ensuring regulatory compliance.

You will design and execute IQ, OQ, PQ protocols, analyse data, resolve issues, and drive documentation workflows. A Bachelor’s degree and 5+ years GMP experience with CQV are required; 3+ years CQV is preferred for this leadership position.