Senior IT Compliance & Validation Specialist

MSD Malaysia; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

MSD Malaysia in Dublin seeks a Senior Technology Compliance Specialist to ensure CSV/SDLC compliance, data integrity, and IT security for biologics manufacturing. The role supports regulatory requirements, audits, and QA processes across the site.

The candidate will liaise with auditors, act as SME for DMO validation, and maintain readiness through reviews and remediation of gaps. A strong IT/compliance background and advanced degree are preferred, with hybrid work arrangements.

Qualifications

• Degree in science, engineering, information technology, or related technical discipline.
• 5–7 years of GxP experience in Computer System Validation (CSV) in life sciences.
• Ability to collaborate across technical, quality, and business functions.
• Strong written and verbal communication to influence stakeholders.
• Experience supporting computerized systems compliance in manufacturing/quality/lab/supply chain.
• Knowledge of automation, instrumentation & control systems, IT compliance, or project management.
• Professional PMP or IT/compliance certifications preferred.
• Experience supporting regulatory inspections and audits.
• SOX IT compliance knowledge.
• Advanced degree in a technical or scientific discipline.

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, and disaster recovery.
• Maintain and execute compliance activities for computerized systems including CAPAs, audit support, cyber security controls, and training.
• Comply with QMS and standards including EU Annex 11, 21 CFR Part 11, GMP Data Integrity, and SOX requirements.
• Act as a 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 periodic reviews, mock audits, and remediation of gaps.

Skills

Audit Management

Change Controls

Collaborative Leadership

Compliance Monitoring

Data Integrity

Data Security

EU Annex 11

Policy and process development

Software Development Life Cycle (SDLC)

Stakeholder Management

Validation Processes

Education

Science, Engineering, IT degree

Master's degree in technical/scientific field

Job description

MSD Malaysia in Dublin seeks a Senior Technology Compliance Specialist to ensure CSV/SDLC compliance, data integrity, and IT security for biologics manufacturing. The role supports regulatory requirements, audits, and QA processes across the site.

The candidate will liaise with auditors, act as SME for DMO validation, and maintain readiness through reviews and remediation of gaps. A strong IT/compliance background and advanced degree are preferred, with hybrid work arrangements.