MSD Ireland Carmanhall and Leopardstown, Dún Laoghaire-Rathdown, IrelandOverviewJoin or sign in to apply for the IT/OT Compliance Lead, Capital Projects role at MSD Ireland. Our Technology Compliance team partners with the business to propose ideas and deliver solutions that increase productivity and enable innovation. We work across countries to support capital projects and ongoing manufacturing operations.ResponsibilitiesLead computer system validation (CSV) activities for Digital Manufacturing Division capital projects.Define and drive CSV strategy and consistent approaches across capital projects in the region.Ensure compliance with the Quality Management System, Systems Development Life Cycle, cybersecurity, and data integrity principles to support compliant manufacture and supply.Act as the subject-matter expert and primary liaison with product and technology teams for computer system validation in capital projects.Recruit, develop and coordinate internal and external CSV resources for program needs.Support development and maintenance of validation templates and standards in the electronic validation system.Provide guidance, training, coaching and ongoing validation support to project and site teams.Coordinate with site compliance/validation, digital teams, quality functions, and other stakeholders to align activities.Drive adoption of automation validation standards and validate automation systems and MES integrations.Identify IT/OT compliance risks, lead remediation activities, and execute risk assessments for new or changed technologies.Support audit responses and work with local quality organizations on compliance strategies.Report trends and challenges in procedural adherence and champion relevant updates to SDLC policies and procedures.Participate in compliance communities to share learnings and improve execution across the division.What Skills You Will NeedBachelor’s degree in Computer Science, Engineering, Regulatory Compliance, or a related field.8+ years supporting compliance and validation activities in capital projects.Strong experience with systems used in digital manufacturing projects, including automation, MES and real time integration.Deep knowledge of Systems Development Life Cycle (SDLC), Quality Management Systems, and computerized systems validation.Familiarity with relevant regulations for computerized systems validation and compliance (for example, 21 CFR Part 11 and regional equivalents).Working knowledge of ISA-95 and ISA-88 standards in a regulated environment.Experience validating cloud, Software-as-a-Service, analytics and data integration platforms.Proven ability to design and implement validation plans and strategies.Experience with automation systems (DCS, PLC/SCADA) and leading validation teams.Good understanding of end-to-end manufacturing processes including manufacturing, quality and supply chain.Strong project management, stakeholder engagement and communication skills; able to explain complex topics clearly to diverse audiences.Strategic thinker who can work with ambiguity, prioritize, and deliver results independently.Preferred and TravelPreferred skills: Prior experience in the pharmaceutical or life sciences sector, especially in manufacturing, supply chain or quality. Experience integrating shopfloor and laboratory systems at enterprise scale with resilience and performance considerations. Background in manufacturing analytics, process modelling or advanced data analysis. Familiarity with business process re engineering and application development methodologies.Travel requirements: Willingness to travel 25-35% for assignments outside your primary location, including short-term travel as needed.Work Environment and Equal OpportunityWe keep the patient at the heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. As an equal opportunity employer, we are proud to bring diverse, talented, and committed people together. We support a flexible, hybrid working model where possible. Please speak to us about what flexibility means to you during your application.Requisition ID: R362477
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