Biotech IT Compliance & CSV Specialist

Msd Ireland; Fingal; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

MSD Ireland in Dublin seeks a Technology Compliance Specialist to assure computerized systems comply with global regulatory, validation, cybersecurity and data integrity standards across the SDLC. You will act as SME for DMO compliance, lead audit support, change controls, access management, disaster recovery, and inspection readiness, and collaborate across technical, quality and business functions.

This hybrid role offers exposure to regulatory inspections and risk mitigation in a fast‑paced

Qualifications

• Degree qualification in Science, Engineering, Information Technology, or a related technical discipline.
• Minimum 3 years' experience in Computer Systems Validation (CSV) within a GxP-regulated environment, preferably pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of CSV, Data Integrity, SDLC, and regulatory compliance requirements.
• Demonstrated ability to collaborate effectively across technical, quality, and business functions.
• Strong verbal and written communication skills with the ability to influence stakeholders at all levels.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies, procedures, and regulatory requirements.
• Execute and maintain compliance activities for computerized systems, including change controls, periodic reviews, access management, disaster recovery, incident and deviation investigations, CAPAs, audit support, cybersecurity controls, policy deployment, training, and system administration.
• Coordinate and support regulatory audits and inspections, acting as a key liaison for auditor requests, documentation management, and inspection tracking activities.
• Serve as Subject Matter Expert (SME) for DMO-owned compliance and validation processes, providing guidance on validation strategy, system compliance, and risk management.
• Maintain continuous inspection readiness through periodic reviews, mock audits, compliance assessments, and proactive remediation of identified gaps.

Skills

IT Compliance

CSV/SDLC

Data Integrity

Regulatory Audits

Stakeholder Management

Education

Bachelor's degree in Science/Engineering/IT

Job description

MSD Ireland in Dublin seeks a Technology Compliance Specialist to assure computerized systems comply with global regulatory, validation, cybersecurity and data integrity standards across the SDLC. You will act as SME for DMO compliance, lead audit support, change controls, access management, disaster recovery, and inspection readiness, and collaborate across technical, quality and business functions.

This hybrid role offers exposure to regulatory inspections and risk mitigation in a fast‑paced