Technology Compliance Specialist / CSV

Merck Gruppe - MSD Sharp & Dohme; Carlow; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Carlow, Ireland, seeks a Technology Compliance Specialist to ensure computerized systems and data management processes meet global regulatory and data integrity standards. You will provide CSV expertise to safeguard the SDLC, support inspections, and help maintain manufacturing quality.

The role covers compliance across SDLC, data integrity, IT security, and regulatory requirements, with expectation to coordinate audits and act as SME for validation strategies

Qualifications

• Required: Degree in science/engineering/IT or related discipline.
• Minimum 3 years' CSV experience in a GxP-regulated environment (pharma/biotech/devices).
• Strong knowledge of CSV, Data Integrity, SDLC and regulatory compliance.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, IT Security policies and regulatory requirements.
• Lead and perform compliance activities for computerized systems including change controls, access management, disaster recovery, audits, and IT security controls.
• Support regulatory inspections and audits, acting as SME for validation strategies and risk management.
• Maintain inspection readiness through reviews, mock audits, and remediation of gaps.

Skills

Auditing Operations

CFR 21 Part 11

Computer Systems Validation (CSV)

Data Integrity

EU Annex 11

FDA Regulations

Gap Assessments

GAMP

Quality Management Systems (QMS)

Systems Development Lifecycle (SDLC)

System Validation

Communication Skills

Education

Degree qualification in Science, Engineering, Information Technology, or related technical discipline

Job description

Location Carlow, Carlow, Ireland Job Type Full time

Job Description

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 Chapter 14 (Computer Systems), EU Annex 11, 21 CFR Part 11, MHRA 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.

What Skills You Will Need

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.

Our Carlow site, which broke ground in 2008, is a strategic manufacturing facility supporting the launch and commercial supply of vaccines, biologics, and small molecule drug products.

Since its establishment, the site has benefited from significant investment and is home to state-of-the-art manufacturing facilities, laboratories, and temperature-controlled warehousing. As a major employer in the South East region, the Carlow site attracts high-performing talent through strong collaborations with local universities and colleges.

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.

Required Skills: Auditing Operations, CFR 21 Part 11, Computer System Validation (CSV), Data Integrity, EU Annex 11, FDA Regulations, Gap Assessments, Good Automated Manufacturing Practice (GAMP), Quality Management Systems (QMS), Systems Development Lifecycle (SDLC), System Validation

Preferred Skills: Audit Readiness, Change Controls, Project Management

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: Yes

Hazardous Material(s): NA

Job Posting End Date: 10/22/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R419013