Senior CSV C&Q Engineer - Brussels - 6-Month Contract
We are looking for an experienced Senior CSV C&Q Engineer for a fantastic 6 month contract based in Brussels.
Working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities
- Act as CSV C&Q Subject Matter Expert and Compliance lead for CSV. Ability to provide guidance to supplier and the rest of the team in all CSV C&Q activities for the system(s), from design to field execution and to summary report approval.
- Draft or provide technical guidance on document drafting by partner/ supplier or internal team, coordinate review and approval of applicable CSV C&Q documents (requirements, testing, reporting) following approved VMP and SLIA.
- Drive correct CSV verification testing, compliance and acceptance. Conduct troubleshoot, deviation investigation and resolution for problems and issues encountered during execution activities. E.g. software module and configuration updates during SFAT and IOV testing.
- Generate and or review change controls related to CSV C&Q and drive closure in a timely manner
- Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.
Experience Required
- 8+ years of Lead/SME experience in International CAPEX Commissioning and Qualification.
- Strong experience with PCS (process automation) + software testing.
- Strong knowledge of Data integrity (21-CFR - Part 11)
- Extensive knowledge and demonstrated experience delivering CSV Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
- Strong understanding of a risk-based approach to CSV commissioning and qualification within the biotechnology industry
- Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ Eudralex Annex 1, ASTM E2500/ electronic execution.
If this role is of interest to you, please apply now!
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