CSV Validation Engineer – GxP Leader in Pharma

Ellab

Tralee

On-site

EUR 65,000 - 95,000

Full time

14 days+

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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.