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CQV Engineer
Job ID: #
ECQV052
Description
As a hands-on CQV Engineer, you will be an integral part of a project team, overseeing the commissioning, qualification, and validation of GMP facilities, process equipment, and critical building and utility systems within our client’s life sciences production facility. This role encompasses the design, implementation, and documentation of these qualifications, along with their life-cycle management, ensuring compliance with all applicable regulatory and internal quality standards (FDA and/or EU regulations).
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Requirements
Bachelor’s - or Master’s degree in engineering, science, or a related technical field (e.g., chemical or mechanical engineering), or an equivalent combination of education and experience.
Proficiency with software (MS Office) and a solid understanding of controlled documentation and data systems.
In-depth knowledge of cGMP regulations.
7+ years of experience in a GMP environment, preferably within the life sciences industry.
5+ years of experience with CQV.
Flexible team player with a solution-driven mindset and a positive attitude.
Customer and result-oriented.
Forward-looking attitude.
Good communication and interpersonal skills.
Proficiency in Dutch, English. German/French is a plus.
Key Responsibilities
Ensure smooth execution of all CQV activities, adhering to project schedules and timelines.
Provide timely, efficient, and high-quality support as needed.
Design, develop, execute, write, and archive C&Q documentation, including systems commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and validation protocols and reports, in line with industry quality standards and guidelines.
Analyze and interpret validation data and results, summarizing findings in final reports.
Identify GMP requirements for validation through design analysis.
Resolve protocol and execution discrepancies, plan follow-up actions, and find satisfactory conclusions.
Make recommendations and decisions regarding test strategies and approaches when appropriate.
Conduct and coordinate validation testing.
Maintain effective communication with team members, share knowledge, and troubleshoot issues.