CSV Engineer

Ellab; Tralee; On-site; EUR 65,000 - 95,000; Full time

Job summary

Ellab UK is seeking an experienced CSV Engineer to lead risk-based validation activities across full system lifecycles in GMP environments. You will develop and execute VP/VMP, URS, risk assessments, IQ/OQ/PQ, traceability and VSR, ensuring stringent data integrity.

Collaboration with QA, IT, Engineering, Automation and Operations is essential. You will ensure adherence to GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ data integrity while supporting regulatory inspections and client

Qualifications

• 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.
• 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.

Responsibilities

• Lead risk-based CSV across the full system lifecycle in GxP environments.
• Develop and execute validation deliverables: VP/VMP, 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.

Skills

CSV validation experience

GAMP 5 knowledge

URS, VP/VMP, IQ/OQ/PQ, VSR

Regulatory compliance (21 CFR Part 11,

Risk-based validation

End-to-end lifecycle validation

Technical writing & documentation

Cross-functional collaboration

Problem solving & analytical thinking

Project management

Education

Engineering, Computer Science, Life Sciences, Pharmaceutical Sciences, or equivalent

Job description

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 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.

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.

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