Senior Technology Compliance Specialist

About the role

The Senior Technology Compliance Specialist will provide IT compliance and validation support for our biotech manufacturing site in Dublin, ensuring adherence to CSV, SDLC, cyber security and data integrity standards for pharmaceutical product manufacturing.

Key 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 investigations, CAPAs and audit support.
• Act as SME for DMO‑owned compliance and validation processes, providing guidance on validation strategy, system compliance and risk management.
• Maintain continuous inspection readiness through mock audits, compliance assessments and proactive remediation of gaps.

Required profile

• Degree in Science, Engineering, IT or related technical discipline.
• 5‑7 years GxP experience in Computer System Validation within life sciences, pharma or medical devices.
• Proven ability to collaborate across technical, quality and business functions.
• Strong verbal and written communication skills with stakeholder influence.

Required skills

• Audit Management
• Change Controls
• Data Integrity
• Data Security
• EU Annex 11
• Software Development Life Cycle (SDLC)
• Validation Processes