Technology Compliance Specialist

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

Job summary

MSD in Dublin's Biotech facility seeks a Technology Compliance Specialist to ensure CSV, data management and SDLC compliance across the DMO and site. You will provide IT compliance and CSV expertise to safeguard the SDLC, support inspections and maintain data integrity.

Requirements include a degree in science/engineering/IT and a minimum of 3 years' CSV experience in a GxP environment, plus strong cross-functional collaboration and communication skills.

Qualifications

• Degree in Science, Engineering, IT or related field.
• Minimum 3 years' CSV experience in a GxP environment.
• Strong knowledge of CSV, Data Integrity, SDLC and compliance requirements.
• Ability to collaborate across technical, quality and business functions.
• Excellent verbal and written communication; stakeholder influence.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity and IT Security policies.
• Manage change controls, periodic reviews, access management, disaster recovery, audits and CAPAs.
• Support applicable regulations including EU Annex 11, 21 CFR Part 11 and SOX.
• Coordinate regulatory audits and inspections; liaise with auditors and manage documentation.
• Serve as SME for DMO validation processes and risk management.
• Maintain inspection readiness through reviews, mock audits and remediation.

Skills

CSV Compliance

Data Integrity

SDLC

Regulatory Compliance

Cross-functional Collaboration

Communication Skills

Audit Support

GxP Knowledge

Education

Bachelor's degree in Science/Engineering/IT

Master's degree (adv)

Tools

Audit Management Tools

Job description

Job Description

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno-oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

The Technology Compliance Specialist is responsible for ensuring that computerized systems, data management processes, and system development activities within the Digital/Data Management Office (DMO) and across the site comply with global regulatory, validation, cybersecurity, and data integrity requirements.This role provides IT compliance and Computer Systems Validation (CSV) expertise to safeguard the Systems Development Lifecycle (SDLC), maintain inspection readiness, and support the continued manufacture and supply of high-quality pharmaceutical products.

Bring energy, knowledge, and innovation to carry out the following:

• 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.
• Support compliance with applicable regulations and standards including , EU Annex 11, 21 CFR Part 11, GMP Data Integrity Guidance, and Sarbanes-Oxley (SOX) requirements.
• 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.

In order to excel in this role, you will more than likely have:

Required

• 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.
• Experience supporting computerized systems compliance activities within manufacturing, quality, laboratory, or supply chain environments.
• Knowledge of one or more of the following areas: Automation, Instrumentation & Control Systems, IT Compliance, or Project Management.

Preferred

• Professional certification in Project Management (PMP) or IT/Compliance-related disciplines.
• Experience supporting or leading regulatory inspections and audits.
• Knowledge of SOX IT compliance requirements.
• Advanced degree (Master's) in a technical or scientific discipline.

We keep patients at the heart of everything we do and are committed to addressing some of the world's most challenging healthcare needs through scientific innovation and operational excellence.As an equal opportunity employer, we value diversity and are committed to fostering an inclusive environment where talented and committed people can thrive and contribute their best work.

Should you require support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role.We are committed to flexible working wherever possible and have introduced a hybrid working model for eligible office-based employees. We encourage candidates to discuss any flexibility requirements during the recruitment process.