CSV Validation Engineer – GMP & 21 CFR Part 11

Careerwise Recruitment; Waterford; On-site; EUR 55,000 - 75,000; Part time

Job summary

CareerWise Recruitment is seeking a CSV Engineer for a Waterford-based client on a 12-month contract. The role covers the full CSV lifecycle across manufacturing, laboratory, and quality systems, with collaboration across Quality, IT, Engineering, and Operations to ensure compliance with GxP and 21 CFR Part 11.

Candidates should have 3-5 years' CSV experience in GMP environments, familiarity with PLC/SCADA/HMI validation, and a degree in Engineering/CS/Life Sciences.

Qualifications

• Experience with CSV in pharma/manufacturing or GMP environments.
• Knowledge of PLC/SCADA/HMI validation and automated control systems.
• Familiarity with Annex 11 / 21 CFR Part 11 compliance and data integrity.
• Experience handling QA inspections, audits, and CAPEX projects.

Responsibilities

• Execute the full CSV lifecycle from planning to periodic review.
• Develop and maintain validation documents (IQ/OQ/PQ, DQ, reports).
• Collaborate with Quality, IT, Engineering, and Operations to ensure compliance.
• Lead validation for new system implementations and upgrades.
• Assess deviations/incidents for validation impact and compliance.
• Support audits and regulatory inspections with validation documentation.

Skills

CSV

PLC/SCADA/HMI

Data integrity

Change control

GMP experience

Education

Engineering/CS/Life Sciences degree

Job description

CareerWise Recruitment is seeking a CSV Engineer for a Waterford-based client on a 12-month contract. The role covers the full CSV lifecycle across manufacturing, laboratory, and quality systems, with collaboration across Quality, IT, Engineering, and Operations to ensure compliance with GxP and 21 CFR Part 11.

Candidates should have 3-5 years' CSV experience in GMP environments, familiarity with PLC/SCADA/HMI validation, and a degree in Engineering/CS/Life Sciences.