CSV Engineer

CareerWise Recruitment; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

CareerWise Recruitment is seeking a CSV Engineer for our Waterford based client. The contract is 12 months.

The role covers execution and support of the CSV lifecycle across manufacturing, laboratory, and utility systems, with responsibility for validation documentation and ensuring GxP compliance (Annex 11, 21 CFR Part 11).

The ideal candidate will have 2–3 years in CSV/automation within GMP environments, strong GAMP 5 knowledge, and collaboration with QA, IT, Eng and Ops.

Qualifications

• Experience with CSV for manufacturing, laboratory, utility, or quality systems.
• Validation of PLC, SCADA, HMI, and automated control systems.
• Data integrity assessments and Annex 11 / 21 CFR Part 11 compliance.

Responsibilities

• Execute and support the full CSV lifecycle, including planning, testing, implementation, and periodic reviews.
• Develop, review, and maintain validation documentation (IQ/OQ/PQ, DQ, Validation Plans, Traceability Matrix).
• Collaborate with QA, IT, Engineering, and Operations to ensure GxP compliance and regulatory readiness.
• Lead validation activities for new system implementations, upgrades, and infrastructure changes.
• Investigate deviations, incidents and change controls to assess validation impact and ensure continued compliance.
• Support internal audits and regulatory inspections with validation documentation and SME input.

Skills

GAMP 5

CSV lifecycle

cGMP compliance

Data integrity

Education

Engineering/CS/Life Sciences degree

Tools

GxP tools

Job description

CSV Engineer is required by CareerWise Recruitment for our Waterford based client.

Contract Length: 12 Months

Responsibilities:

• Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
• Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
• Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
• Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
• Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
• Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as required.

Requirements:

• Experience with Computer System Validation (CSV) for manufacturing, laboratory, utility, or quality systems.
• Validation of PLC, SCADA, HMI, and automated control systems.
• Experience with data integrity assessments and Annex 11 / 21 CFR Part 11 compliance.
• Experience supporting GMP inspections, audits, and CAPEX project delivery within regulated pharmaceutical environments. Required Experience & Qualifications
• Degree or equivalent qualification in Engineering, Computer Science, Life Sciences, or a related technical discipline.
• 3-5 years' experience within a pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environment.
• 2-3 years' experience in Computer System Validation (CSV), Validation, Automation, or a related compliance-focused role.
• Strong knowledge of GAMP 5, CSV lifecycle activities, cGMP requirements, and relevant regulatory expectations.
• Experience generating and executing validation documentation including DQ, IQ, OQ, PQ, and validation reports. Experience with change control, deviation management, and maintaining validated systems throughout their lifecycle

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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