We are partnering with a global leader in biotechnology, renowned for its cutting-edge advancements in the life sciences sector. Our client is seeking a highly skilled CQV Engineer for a 12-month contract, focusing on the qualification of clean rooms, isolators, and a pre-filled syringe line, to join their team.
About the job
CQV Engineer
Greater Hamburg Area – Onsite
12 Month Contract
This role is critical for ensuring that all systems and equipment meet stringent quality standards and regulatory requirements.
Documentation & Support:
* Design, develop, execute, and archive Commissioning and Qualification (C&Q) documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and validation protocols and reports.
* Provide timely, efficient, and high-quality support throughout the qualification process.
Data Analysis & Reporting:
* Analyze and interpret validation data, summarizing findings in comprehensive final reports.
* Assess design specifications to identify and implement GMP requirements for validation.
* Address and resolve protocol and execution discrepancies, plan follow-up actions, and provide recommendations for test strategies and approaches.
* Ensure accurate and effective resolution of issues.
Validation Testing:
* Conduct and coordinate validation testing, ensuring compliance with all relevant standards and guidelines.
Team Collaboration:
* Maintain effective communication with team members, share expertise, and troubleshoot technical challenges as they arise.
Required Qualifications
* Proven experience in CQV activities, particularly with clean rooms, isolators, and production lines.
* Deep understanding of quality standards and guidelines specific to the life sciences industry.
* Proficiency in designing, developing, and executing C&Q documentation.
* Professional German language abilities.
Sounds like a fit? Click apply.
Please note, you will only be considered if you have the required experience listed.