Senior IT Compliance & Validation Lead

MSD; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Merck & Co., Inc. in Dublin's Biotech facility seeks a Senior Technology Compliance Specialist to provide IT compliance/validation support to the DMO team, ensuring CSV, SDLC, data integrity, cyber security, and quality manufacturing standards.

You will lead change controls, periodic reviews, access management, disaster recovery, incidents, CAPAs, and audit support while aligning with EU Annex 11, 21 CFR Part 11, SOX IT controls, and QMS requirements.

Qualifications

• Degree in Science, Engineering, IT or 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.
• Strong written and verbal communication for stakeholder influence.
• Experience supporting computerized systems compliance in manufacturing, quality, lab or supply chain.
• Knowledge in Automation, Instrumentation & Control Systems, IT Compliance or Project Management.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, IT Security policies and regulatory requirements.
• Plan and execute project/compliance deliverables: change control, periodic reviews, access management, disaster recovery, deviations, investigations.
• Manage compliance activities for computerized systems (CAPAs, audit support, cybersecurity controls, policy deployment).
• Comply with QMS and EU Annex 11, 21 CFR Part 11, GMP Data Integrity Guidance and SOX IT requirements.
• Act as liaison for audit requests, documentation management, and inspection tracking.
• Serve as SME for DMO-owned compliance/validation processes, guiding validation strategy and risk management.
• Maintain inspection readiness via periodic reviews, mock audits and proactive remediation.

Skills

Audit Management

Change Controls

Collaborative Leadership

Compliance Monitoring

Data Integrity

Data Security

EU Annex 11

Policy and process development

Software Development Life Cycle

Stakeholder Management

Validation Processes

Education

Bachelor's degree in Science/Engineering/IT

Job description

Merck & Co., Inc. in Dublin's Biotech facility seeks a Senior Technology Compliance Specialist to provide IT compliance/validation support to the DMO team, ensuring CSV, SDLC, data integrity, cyber security, and quality manufacturing standards.

You will lead change controls, periodic reviews, access management, disaster recovery, incidents, CAPAs, and audit support while aligning with EU Annex 11, 21 CFR Part 11, SOX IT controls, and QMS requirements.