CSV Engineer

Ellab; Tralee; On-site; EUR 90,000 - 130,000; Full time

Job summary

Ellab in Ireland seeks an experienced CSV Engineer to lead validation across GxP environments for pharma/biotech/medical device clients. You will develop and execute VP/VMP, URS, risk assessments, IQ/OQ/PQ, and maintain end-to-end traceability, while collaborating with QA, IT, Engineering, and Operations to drive continuous improvement and regulatory readiness.

The role demands proven CSV experience, strong GAMP 5 knowledge, and hands-on validation documentation. Travel may be involved.

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 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.

Responsibilities

• Lead risk-based CSV across the full system lifecycle in GxP environments.
• Develop and execute validation deliverables: VMP/VP, URS, risk assessments, test scripts, IQ/OQ/PQ, traceability, VSR.
• 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.
• 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

GxP compliance

ALCOA+

Validation documentation

Change Control

Risk-based validation

Cross-functional collaboration

Technical writing

Analytical skills

Organizational skills

Education

Engineering degree

Life Sciences degree

Pharmaceutical Sciences degree

Tools

IQ/OQ/PQ

URS

VMP/VSR

GAMP 5

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