Ellab
CSV Engineer
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Exciting opportunity for experienced CSV Engineers with Ellab UK
As part of a trusted global leader in validation, monitoring, and compliance services, you’ll work with cutting-edge technologies and blue‑chip pharma, biotech, and medical device clients. We offer meaningful projects, professional growth, and a collaborative, high‑standards culture where your expertise in CSV makes a real impact.
Responsibilities:
- Lead risk-based CSV across the full system lifecycle (implementation to retirement) in GxP environments.
- Develop and execute validation deliverables: VMP/VP, URS, risk assessments, test scripts, IQ/OQ/PQ, traceability, VSR.
- Ensure compliance with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity.
- Plan and run testing, document results accurately, investigate deviations, and close actions promptly.
- Manage Change Control, Deviations, CAPA, and Periodic Reviews to maintain validated state.
- Collaborate with QA, IT, Engineering, Automation, and Operations on scoping, delivery, and sustainment.
- Validate platforms such as LIMS, MES, EMS/BMS, SCADA/PLC, QMS, ERP, temperature monitoring, and lab systems.
- Apply CQV and risk-based approaches to size effort and ensure fit-for-purpose compliance.
- Prepare for and support regulatory inspections and customer audits.
- Produce high-quality GMP/GDP documentation with end-to-end requirements-to-test traceability.
- Run multiple validation workstreams independently; communicate status, risks, and decisions clearly.
- Drive continuous improvement of CSV processes, templates, and standards.
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Requirements:
- Proven CSV experience in regulated pharma/biotech/medical device/healthcare.
- Strong knowledge of GAMP 5, GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
- Hands-on with validation docs: VP/VMP, URS, risk assessments, test scripts, IQ/OQ/PQ, traceability, VSR.
- End-to-end lifecycle validation experience (implementation through retirement).
- Skilled in developing/executing test scripts and documenting results accurately.
- Experience with Change Control, Deviations, CAPA, and Periodic Reviews.
- Applied risk-based validation and system lifecycle management.
- GMP/GDP documentation standards and Good Documentation Practice.
- Cross-functional collaboration with QA, IT, Engineering, Automation, and Operations.
- Excellent technical writing, communication, analytical, and problem-solving skills.
- Able to manage multiple projects independently with strong organization.
- Degree in Engineering, Computer Science, Life Sciences, Pharmaceutical Sciences, or equivalent experience.
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Desirable:
- Validation of LIMS, MES, EMS/BMS, SCADA/PLC, QMS, ERP, temperature monitoring, calibration/lab systems.
- Support for regulatory inspections and customer audits.
- Knowledge of CQV; client-facing project experience.
- Flexible to travel; full UK driving licence
If this sounds like you please feel free to click apply.
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