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.
Required Skills: Annex 11, Information Technology (IT) Projects, IT Compliance Management, IT Maintenance, Regulatory Audits, Stakeholder Management Preferred Skills:
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Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid Shift:
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Job Posting End Date: 10/19/2026*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.