CSV & Data Integrity Lead: Govern GxP Systems & Compliance

GE HealthCare; Cork; On-site; EUR 110,000 - 140,000; Full time

Job summary

GE HealthCare in Cork, Ireland is seeking a CSV & Data Integrity Lead to maintain and enhance the site's computerized systems validation framework and data integrity program. The role partners with Engineering, Quality, Manufacturing and IT to ensure compliant lifecycle management of GxP systems.

Reporting to the Automation Manager, the candidate will drive validation strategies, manage Change Controls and support inspections and audits, ensuring systems remain inspection-ready and aligned with

Qualifications

• Degree in Engineering, Computer Science, Life Sciences or related discipline.
• Significant experience leading Computerized Systems Validation across full lifecycle.
• Strong knowledge of Data Integrity and ALCOA+ requirements.
• Familiarity with regulatory requirements for computerized systems (EU GMP Annex 11, FDA 21 CFR Part 11) and CSA methodologies.
• Experience delivering complete validation documentation packages.

Responsibilities

• Lead CSV and Data Integrity framework improvements.
• Maintain site inventory of GxP computerized systems.
• Ensure validation activities meet site procedures and regulatory requirements.
• Collaborate with Engineering, Quality, Manufacturing, IT and external vendors.
• Develop validation strategies, plans, risk assessments and test protocols.
• Maintain traceability matrices and data lifecycle documentation.
• Lead Data Integrity assessments and continuous improvement initiatives.
• Support regulatory inspections and audits.

Education

Degree in Engineering, Computer Science, Life Sciences

Tools

TrackWise

DCS/PLC/SCADA systems

BMS/Historian

Job description

GE HealthCare in Cork, Ireland is seeking a CSV & Data Integrity Lead to maintain and enhance the site's computerized systems validation framework and data integrity program. The role partners with Engineering, Quality, Manufacturing and IT to ensure compliant lifecycle management of GxP systems.

Reporting to the Automation Manager, the candidate will drive validation strategies, manage Change Controls and support inspections and audits, ensuring systems remain inspection-ready and aligned with