Job Description
An exciting opportunity to join the Ballydine site as a Senior Specialist in IT Compliance. The successful candidate will be computerised systems validation lead for the site. This role will be within the technical unit, ensuring adherence to policies/procedures and driving continuous improvement with a risk-based, lean approach to computerised systems compliance.
Key Responsibilities
* Lead/support site and cross-functional teams on computerized system validation and information technology and operational technology (IT/OT) compliance.
* Support Computerized System Digital Validation System Development Lifecycle (SDLC), CSA, Inventory, Change, and Deviation Management.
* Ensure compliance deliverables
* Represent compliance during audits/inspections and develop audit responses.
* Identify and remediate IT/OT compliance risks; support risk assessments for new tech or changes.
* Support compliance operations in Automation and IT teams.
* Assist local teams with quality/compliance challenges and SOP adherence.
* Monitor deviations/CAPAs and communicate SDLC policy changes.
* Collaborate with compliance groups and other sites to share best practices.
Skills & Experience
* Bachelor’s in Computer Science, Engineering, Regulatory Compliance, or related.
* 5+ years in compliance support.
* Strong knowledge of 21CFR Part 11, EMEA Annex 11, GAMP 5
* Experience managing internal/external auditors.
* Understanding of Pharmaceutical Manufacturing, Quality, and Supply Chain processes.
* Strong stakeholder management and communication skills.
* Strategic thinker, results-driven, self-motivated leader.
* Expertise in Computer Systems Validation, Instrumentation/Automation, Project Management.
* Experience with real-time shopfloor/lab systems integration.
* Exposure to diverse technologies and business process re-engineering.
* Lean Six Sigma Green Belt is an advantage.
Current Employees apply HERE
Current Contingent Workers apply HERE
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
Valid Driving License:
Hazardous Material(s)
Required Skills:
Audit Management, Business, Governance Management, IS Audit, Management Process, Quality Assurance (QA), Quality Management, Risk Management, Technical Advice
Preferred Skills
Job Posting End Date:
09/5/2025
* 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:R361615 #J-18808-Ljbffr