Computerized Systems Validation (CSV) & Data Integrity Lead

GE HealthCare; Ireland; On-site; EUR 120,000 - 150,000; Full time

Job summary

GE HealthCare in Ireland seeks an experienced lead for Computerized Systems Validation (CSV) & Data Integrity to maintain and enhance the site validation framework and data governance. You will partner with Engineering, Quality, Manufacturing, IT and external suppliers to ensure compliant lifecycle management of computerized systems.

Role requires strong regulatory knowledge, cross-functional collaboration, and leadership in CS validation activities across the lifecycle, with attention to ALCOA+

Qualifications

• Significant experience leading CSV activities across full lifecycle.
• Strong knowledge of data integrity principles and ALCOA+.
• Familiarity with EU GMP Annex 11 and FDA/CSA methodologies.

Responsibilities

• Own and improve CSV and Data Integrity procedures and governance.
• Review site inventory of GxP computerized systems.
• Ensure validation activities meet regulatory requirements and best practice.
• 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, audits and responses.

Skills

CSV leadership

Data Integrity

Regulatory compliance

GxP systems

CSA methodologies

Cross-functional collaboration

Change management

Education

Degree in Engineering/CS/Life Sciences

Tools

TrackWise

DCS/SCADA

Job description

Job Description Summary

As the Computerized Systems Validation (CSV) & Data Integrity Lead you'll be responsible for maintaining and continuously improving the site's computerized systems validation framework and data integrity programme. The role serves as the site SME for computerized systems compliance, ensuring GxP systems remain compliant, inspection-ready and aligned with evolving regulatory and industry requirements.

Reporting to the Automation Manager, this position partners with Engineering, Quality, Manufacturing, IT and external suppliers to support compliant implementation and lifecycle management of computerized systems across the site.

Responsibilities

• Own and continuously improve CSV and Data Integrity procedures, standards, templates and governance processes.
• Maintain and periodically review the site inventory of GxP computerized systems.
• Ensure computerized systems validation activities are performed in accordance with site procedures, regulatory requirements and industry best practice.
• Work closely with Engineering, Quality, Operations, IT and external vendors to ensure validation deliverables meet site and regulatory requirements.
• Develop and approve validation strategies, validation plans, risk assessments, requirements specifications, test protocols and validation summary reports as required.
• Ensure appropriate application of Computer Software Assurance (CSA) and risk-based validation methodologies.
• Maintain Requirements Traceability Matrices and Data Lifecycle documentation for applicable systems.
• Lead Data Integrity assessments, gap analyses and continuous improvement initiatives.
• Promote compliance with ALCOA+ principles and Data Integrity requirements across site functions.
• Ensure appropriate change management processes are followed for computerized system introductions, upgrades and modifications.
• Develop and execute Change Controls and TrackWise records for computerized systems where required.
• Review and approve vendor validation documentation and ensure supplier deliverables satisfy site requirements.
• Support and attend Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), commissioning and qualification activities as required.
• Lead or support periodic reviews to ensure computerized systems remain in a validated state.
• Monitor developments in regulations and industry guidance including Annex 11, 21 CFR Part 11, GAMP 5, Data Integrity Guidance and CSA practices.
• Maintain awareness of evolving regulatory and industry expectations & best practices and ensure timely implementation into site procedures and practices.
• Serve as SME during regulatory inspections, customer audits and internal audits.
• Support audit preparation activities and lead responses to computerized system and Data Integrity observations.
• Provide technical leadership and mentoring to Engineering, Automation, Quality and Operations personnel in CSV and Data Integrity best practices.
• Work collaboratively to ensure key commitments, project milestones and compliance objectives are achieved.
• Required to comply with Procedures and Guidelines, regulatory requirements and execute cGMP in the performance of day-to-day activities and all applicable job functions.

Qualifications And Requirements

• Relevant qualification (Degree) in Engineering, Computer Science, Life Sciences or a related discipline.
• Strong experience in pharmaceutical, biotechnology, medical device or other regulated manufacturing environments.
• Significant experience leading Computerized Systems Validation activities across the full computerized system lifecycle, from concept and implementation through operation, periodic review and retirement.
• Strong knowledge of Data Integrity principles, data lifecycle management and ALCOA+ requirements.
• Thorough understanding of regulatory requirements relating to computerized systems and electronic records, including EU GMP Annex 11, FDA 21 CFR Part 1, GAMP 5, Data Integrity Guidance (FDA, MHRA, PIC/S) & Computer Software Assurance (CSA) methodologies
• Experience delivering and approving complete validation documentation packages.
• Experience validating automation and manufacturing systems including DCS, PLC, SCADA, BMS, Historian and related GxP systems is desirable.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Demonstrated ability to influence cross-functional teams and provide technical leadership.
• Ability to work independently and manage multiple priorities in a regulated environment.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No