Senior IT Compliance & Validation Specialist

Merck Gruppe - MSD Sharp & Dohme; Swords; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Merck Gruppe - MSD Sharp & Dohme in Dublin seeks a Senior Technology Compliance Specialist to support CSV, SDLC, cyber security and data integrity for biologics manufacturing. You will ensure regulatory compliance, manage change control, audits, and validation activities across the DMO team and site operations.

The role requires 5–7 years GxP CSV experience, collaboration across technical and quality functions, and strong communication to influence stakeholders.

Qualifications

• Degree qualification in Science, Engineering, Information Technology, or a related technical discipline.
• 5-7 years GxP experience in Computer System Validation (life science, pharma, medical devices).
• Experience collaborating across technical, quality and business functions in a dynamic environment.
• Knowledge of SDLC, CSV, data integrity, IT compliance and regulatory requirements.

Responsabilités

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies, procedures, and regulatory requirements.
• Manage supply of compliance components and deliverables including change control, periodic reviews, access administration, disaster recovery and investigations.
• Coordinate compliance activities for computerized systems: change controls, periodic reviews, access management, disaster recovery, CAPAs, audits, cybersecurity controls, policy deployment, training, and administration.
• Ensure QMS compliance with EU Annex 11, 21 CFR Part 11, SOX and related guidances.
• Act as liaison for auditor requests, documentation management, and inspection tracking.
• Serve as SME for DMO-owned compliance and validation processes, guiding validation strategy and risk management.
• Maintain inspection readiness through mock audits, assessments, and remediation of gaps.

Connaissances

Audit Management

Change Controls

Collaborative Leadership

Compliance Monitoring

Data Integrity

Data Security

EU Annex 11

SDLC

Policy & Process Development

Stakeholder Management

Validation Processes

Formation

Science/Engineering/IT degree

Description du poste

Merck Gruppe - MSD Sharp & Dohme in Dublin seeks a Senior Technology Compliance Specialist to support CSV, SDLC, cyber security and data integrity for biologics manufacturing. You will ensure regulatory compliance, manage change control, audits, and validation activities across the DMO team and site operations.

The role requires 5–7 years GxP CSV experience, collaboration across technical and quality functions, and strong communication to influence stakeholders.