Senior IT Compliance & Validation Specialist

MSD; Fingal; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Flexible working arrangements

Job summary

MSD in Ireland is seeking a Senior Technology Compliance Specialist to join our Biotech team in Dublin. You will support IT compliance/validation for CSV and SDLC, ensuring data integrity and cyber security for biologics manufacturing.

You will act as SME for DMO validation processes, coordinate audits, and drive inspection readiness. A degree in a technical field and 5–7 years of GxP CSV experience are required, with a hybrid working arrangement offered.

Qualifications

• 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.
• Strong verbal and written communication to influence stakeholders at all levels.
• Experience supporting computerized systems compliance in manufacturing, quality, lab, or supply chain.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies and regulatory requirements.
• Plan and execute project and compliance deliverables including change control, periodic reviews, access admin, disaster recovery, deviations, investigations.
• Manage compliance activities for computerized systems: change controls, periodic reviews, access management, DR, CAPAs, audits, cybersecurity controls, policy deployment, training, system administration.
• Comply with QMS regulations including EU Annex 11, 21 CFR 11, GMP Data Integrity, SOX requirements.
• 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 reviews, mock audits, assessments, and remediation of gaps.

Skills

Audit Management

Change Controls

Collaborative Leadership

Compliance Monitoring

Data Integrity

Data Security

EU Annex 11

Policy & Process Development

SDLC

Stakeholder Management

Validation Processes

Education

Bachelor's degree in Science/Engineering/IT

Job description

MSD in Ireland is seeking a Senior Technology Compliance Specialist to join our Biotech team in Dublin. You will support IT compliance/validation for CSV and SDLC, ensuring data integrity and cyber security for biologics manufacturing.

You will act as SME for DMO validation processes, coordinate audits, and drive inspection readiness. A degree in a technical field and 5–7 years of GxP CSV experience are required, with a hybrid working arrangement offered.