At a Glance
- Tasks: Lead CSV projects in regulated environments and ensure compliance with industry standards.
- Company: Join a global leader in validation and compliance services, working with top pharma and biotech clients.
- Benefits: Enjoy professional growth, competitive salary, and a collaborative work culture.
- Other info: Flexible travel opportunities and excellent career advancement potential.
- Why this job: Make a real impact on innovative projects while working with cutting-edge technologies.
- Qualifications: Experience in CSV and strong knowledge of GxP regulations required.
The predicted salary is between 45000 - 55000 £ per year.
Exciting opportunity for experience 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 Gx P 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.
Requirements
- Proven CSV experience in regulated pharma/biotech/medical device/healthcare.
- Strong knowledge of GAMP 5, Gx P, 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.
- 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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CSV Engineer employer: Ellab
At Ellab UK, we pride ourselves on being a leading employer in the validation and compliance sector, offering CSV Engineers the chance to work with innovative technologies and prestigious clients in the pharma and biotech industries. Our collaborative culture fosters professional growth and meaningful contributions, ensuring that your expertise not only enhances your career but also makes a significant impact on the industry. With a commitment to high standards and continuous improvement, we provide an environment where you can thrive and develop your skills while working on exciting projects.
