Technology Compliance Specialist / CSV

Msd Ireland; Carlow; Hybrid; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. in Ireland's Carlow site seeks a Technology Compliance Specialist to assure SDLC/CSV, data integrity, and IT security in a regulated manufacturing context.

You will provide expert guidance on validation strategy and risk management while maintaining inspection readiness and supporting audits. The role requires a Science/Engineering/IT degree and 3+ years in CSV within a GxP environment, with strong cross-functional collaboration and communication skills.

Qualifikationen

• Degree in science, engineering, IT, or related technical discipline.
• 3+ years in CSV within a GxP environment (pharma/biotech/medical devices).
• Strong knowledge of CSV, Data Integrity, SDLC and regulatory compliance.

Aufgaben

• Ensure compliance with Global SDLC/CSV, Data Integrity and IT Security policies.
• Execute change controls, periodic reviews, access management, incident investigations and CAPAs.
• Support audits and inspections, manage documentation and inspection tracking.
• Act as SME for DMO compliance and validation processes, guiding risk management.

Kenntnisse

Auditing Operations

CFR 21 Part 11

Computer System Validation (CSV)

Data Integrity

EU Annex 11

FDA Regulations

Gap Assessments

GAMP

QMS

SDLC

System Validation

Ausbildung

Bachelor's degree in Science, Engineering, IT, or related field

Jobbeschreibung

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.

Required

What Skills You Will Need

• 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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

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.

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.

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