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Commissioning and Qualification (C&Q) Engineer
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Location | Belgium |
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Job Type | Contract |
Our client in Belgium are currently in need of a C&Q engineer with a strong focus on autoclaves alongside some filling lines and parts washer for a one year contract.
Responsibilities
As the Commissioning and Qualification (C&Q) Process Engineer, you will be involved with executing CQV activities, providing expert guidance and overseeing the C&Q segment of the project. In this role, you will ensure that all C&Q activities are executed safely, on schedule, and in full compliance with system requirements, specifications, and project procedures or guidelines.
Other responsibilities include:
- Accountable for drafting C&Q documents or supporting document creation by partners or suppliers, as well as coordinating the review and approval process for relevant C&Q documentation (QRA, DV, RTM, FAT, SAT, IOV, VSR) in accordance with the approved VMP and SLIA.
- Serve as the C&Q Subject Matter Expert, ensuring compliance and providing guidance on managing suppliers and all C&Q activities for the systems from design through field execution to final report approval.
- Lead verification testing, protocol execution, system walk-downs, verification of system drawings, design and operational testing, and troubleshooting as needed. Conduct investigations and resolve deviations encountered during field execution.
- Responsible for planning, tracking, and reporting on C&Q status, risks, and issues for the selected systems.
- Accountable for the team’s review and acceptance of equipment/system turnover from the construction group.
- Generate and review change controls related to C&Q and drive their timely closure.
- Ensure that all personnel involved in C&Q activities for the systems have the necessary training.
- Assist in developing User Requirement Specifications (URS) and Quality Risk Assessments for equipment and systems within scope.
Requirements
- Over 5 years of hands-on, end-to-end experience with this equipment in international CAPEX C&Q projects.
- Technical qualification at a third-level or equivalent in Engineering. Proficiency in English is essential.
- Extensive knowledge and proven experience in delivering Commissioning and Qualification for Pharmaceutical/Biotechnology projects, including automation aspects of equipment.
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry, with experience in ISPE best practices, GAMP-5, Annex 15 GMP EU and ASTM E2500.
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If this position interests you, and you would like to learn more or explore other available jobs that could also match your skill set, please apply today or email vi@blackfieldassociates.com