Technology Compliance Specialist

MSD Malaysia; Dublin; Hybrid; EUR 70,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

VISA Sponsorship

Relocation assistance

Job summary

Our Company in Ireland's Dublin Biotech facility seeks a Technology Compliance Specialist to ensure computerized systems comply with regulatory standards. The role covers CSV, SDLC, data integrity, IT security, and regulatory readiness across the DMO and site operations.

Ideal candidates hold a technical degree with 3+ years of CSV experience in a GxP environment and strong cross-functional communication skills to influence stakeholders at all levels.

Qualifications

• Requires degree in a technical field and 3+ years in CSV within a GxP setting.
• Strong knowledge of CSV, data integrity, SDLC, and regulatory compliance.
• Experience collaborating with quality, IT, and manufacturing functions.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies.
• Lead change controls, periodic reviews, access management, and incident investigations.
• Support audits and regulatory inspections and documentation management.
• Act as SME for DMO validation processes and risk management.
• Maintain inspection readiness through mock audits and corrective actions.

Skills

CSV Knowledge

GxP Compliance

Data Integrity

Stakeholder Mgmt

Education

Degree in Science/Engineering/IT

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.

Should you require support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role.

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.
• 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.

Qualifications

• 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.

Required Skills

• Annex 11
• Information Technology (IT) Projects
• IT Compliance Management
• IT Maintenance
• Regulatory Audits
• Stakeholder Management

Other Information

• Employee Status: Regular
• Relocation: VISA Sponsorship
• Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):
• Job Posting End Date: 10/19/2026

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.

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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.