About the role
CSV Engineer (Delta V) – Singapore – 24-Month Contract – Life Sciences How would you like the opportunity to support one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you!
Our client is currently seeking the skills of a CSV Engineer to support their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!
What You’ll Deliver
- Plan, execute, and manage Computer System Validation (CSV) activities for DeltaV systems, including validation strategy, risk assessments, traceability, and lifecycle compliance.
- Qualify DeltaV hardware and software, including Professional Plus, operator/application stations, controllers, CIOCs, I/O systems, networks, virtual environments, control modules, equipment modules, batch recipes, alarms, and graphics.
- Develop and execute IQ, OQ, PQ, FAT, SAT, and regression testing while ensuring complete traceability from requirements through testing and final validation reporting.
- Verify audit trails, electronic signatures, user access controls, backup/restore functionality, security configurations, and support cybersecurity, change control, and deviation management activities in regulated GMP environments.
Experience required:
- Extensive hands-on DeltaV CSV experience, including qualification of DeltaV hardware infrastructure and software applications.
- Strong validation experience within regulated pharmaceutical or biotechnology manufacturing environments.
- Strong understanding of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP principles, and Data Integrity requirements.
- Proven experience authoring and reviewing validation deliverables (URS, FS, DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols and reports) and collaborating with Automation, CQV, Quality, IT, Manufacturing, and vendor teams.
Apply now to become a part of this life changing project!
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