CSV Engineer

This company is a leading systems integrator in Ireland, is seeking an experienced CSV (Computer System Validation) Engineer for a 12-month contract based full-time on-site at a pharmaceutical manufacturing facility in Northern Ireland. This is a fantastic opportunity to work on a high-profile project, ensuring the validation of automation systems within a GMP-regulated environment.

• Lead and execute validation activities for automation systems, focusing on DCS/PLC systems within a pharmaceutical manufacturing site.

• Develop and implement validation documentation including URS, IQ, OQ, PQ, and validation plans.

• Ensure compliance with regulatory requirements (e.g. GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11).

• Perform risk assessments, impact assessments, and deviation investigations.

• Collaborate with cross-functional teams including automation, quality, and IT departments.

• Provide support during audits and inspections related to system validation.

• 4-10 years of experience in Computer System Validation within the pharmaceutical or life sciences sector.

• Hands-on experience validating DeltaV systems preferred; other DCS or PLC systems will also be considered.

• In-depth knowledge of GMP, GAMP 5, and regulatory expectations.

• Proven ability to author, review, and execute validation protocols and reports.

• Strong problem-solving, documentation, and communication skills.

• Ability to work independently on-site in a fast-paced environment.