C&Q Lead Engineer
Our client is a values-based biotechnology organization driven by a powerful sense of shared purpose toward its mission to serve patients. At their facility near Breda, they specialize in the manufacturing and distribution of innovative radiopharmaceuticals used for medical treatments. The C&Q Lead Engineer will ensure the safety, quality, and efficacy of produced products by overseeing the commissioning and qualification activities of all systems and processes that impact product quality.
Key Responsibilities:
* Responsible for overview and planning of the commissioning & qualification (C&Q) activities, including the documentation matrix and RACI.
* Author protocols and reports regarding the commissioning and qualification of manufacturing equipment, cleanrooms, and utilities.
* Execute required tests in collaboration with the Production department or external suppliers where applicable.
* Manage the requalification program of the site during the lifecycle.
* Ensure all activities are documented and executed according to cGMP and quality requirements.
* Prepare protocols for qualification (FAT, SAT, IQ, OQ, PQ) of process equipment and building & utility validation.
* Execute commissioning/qualification tests in collaboration with the Production department or accompany external suppliers.
* Keep the documentation matrix up to date.
* Maintain an overview of deliverables and milestones.
Key Activities:
* Timely execution of commissioning and qualification activities in compliance with all applicable internal and external regulations.
* Consistent application of Good Documentation Practices (GDP).
* Education: Degree in Engineering, Medical/Pharmaceutical Sciences, Biotechnology (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent.
* Languages: Fluent in Dutch and English (writing, reading, and speaking).
* Experience: Preferred qualifications include 5+ years of working experience within the pharmaceutical industry in a technical/validation role.
* Basic knowledge of radioactivity and radioprotection is preferred.
* Advanced knowledge of clean room environments and production processes is preferred.
* Project management skills with the capability to handle multiple tasks simultaneously.
* Basic IT skills.
* Strong analytical and reporting skills.
* Ability to work in a multi-disciplinary environment/team.
Details:
* Hours: 40 hours per week, on-site
* Project Length: 6-12 months (with possible extension).
* Location: Breda Area, The Netherlands.
Apply Now: Are you the C&Q Lead Engineer we’re looking for? Please contact Tom van Marsbergen via +31 (0)20 522 1588 or ort.vanmarsbergen@realstaffing.com.
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