Pharma IT Compliance & CSV Specialist

MSD; Fingal; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

MSD in Dublin is seeking a Technology Compliance Specialist to ensure computerized systems meet global regulatory, validation, cybersecurity, and data integrity standards. The role provides IT compliance and CSV expertise across the DMO and site to safeguard the SDLC and support high-quality pharmaceutical manufacturing.

You will coordinate audits, act as SME for validation processes, and drive remediation of identified gaps, while maintaining inspection readiness in a hybrid work arrangement.

Qualifications

• Degree in Science, Engineering, IT or related technical discipline.
• Minimum 3 years' CSV experience in a GxP-regulated environment (pharma/biotech/medical devices).
• Strong knowledge of CSV, Data Integrity, SDLC, and regulatory compliance.
• Ability to collaborate across technical, quality and business functions.
• Excellent verbal and written communication with stakeholder influence.
• Experience supporting computerized systems compliance within manufacturing, QA, lab, or supply chain.
• Knowledge of Automation, Instrumentation & Control Systems, IT Compliance, or Project Management.

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

CSV knowledge

Data Integrity

SDLC

Regulatory compliance

Cross-functional collaboration

Verbal and written communication

GxP environments

Education

Degree in Science/Engineering/IT

Job description

MSD in Dublin is seeking a Technology Compliance Specialist to ensure computerized systems meet global regulatory, validation, cybersecurity, and data integrity standards. The role provides IT compliance and CSV expertise across the DMO and site to safeguard the SDLC and support high-quality pharmaceutical manufacturing.

You will coordinate audits, act as SME for validation processes, and drive remediation of identified gaps, while maintaining inspection readiness in a hybrid work arrangement.