CSV Engineer
Location:
Cork, Ireland
Contract duration:
12 month contract
We are seeking a mid-level Computer System Validation (CSV) Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. This role is focused on hands-on execution of CSV lifecycle activities, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.
About the Role
We are seeking a mid-level Computer System Validation (CSV) Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. This role is focused on hands-on execution of CSV lifecycle activities, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.
Responsibilities
* Execute CSV lifecycle activities for GMP computerized systems including MES, DCS, SCADA, and automated equipment
* Prepare and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reports
* Apply risk-based validation approaches for new and existing systems
* Ensure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11
* Support project teams to align validation activities with delivery timelines
* Participate in validation risk assessments and define testing scope
* Review system specifications, design documents, and qualification records
* Support deviation management, discrepancy resolution, and data integrity assessments
* Assist with periodic system reviews, audits, and regulatory inspections
* Support development and maintenance of CSV and qualification SOPs
* Collaborate with cross-functional and global CSV teams
* Escalate quality or compliance risks where required
* Follow EHS and site safety procedures during validation activities
Qualifications
* Bachelor's degree in Engineering, Life Sciences, Computer Science, or related discipline
* 4–7 years' experience in Computer System Validation within pharma or biopharma
* Strong understanding of CSV regulations and quality expectations
* Hands-on experience validating GAMP Category 3, 4, and 5 systems
* Experience executing validation protocols and managing validation documentation
* Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines
* Experience supporting investigations, root cause analysis, and CAPAs
* Strong documentation and cross-functional collaboration skills
Required Skills
* Strong understanding of CSV regulations and quality expectations
* Hands-on experience validating GAMP Category 3, 4, and 5 systems
* Experience executing validation protocols and managing validation documentation
* Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines
* Experience supporting investigations, root cause analysis, and CAPAs
* Strong documentation and cross-functional collaboration skills
Preferred Skills
* Experience in a GMP environment
* Familiarity with EHS and site safety procedures