Job Description

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.

In this role, you will lead IT/OT compliance for capital projects, ensuring regulatory and quality requirements are met while promoting a risk-based, efficient approach. You will be the subject-matter expert on computer system validation for capital projects, coach project teams, and help embed consistent, compliant practices across sites and programs.

Bring energy, knowledge, innovation to carry out the following:

Lead 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 need:

In order to excel in this role, you will more than likely have:

Bachelor’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 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.

We keep the patient at the very 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 be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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:

Adaptability, Automation, Capital Projects, Cloud Computing, Coaching, Collaboration, Communication, Computer System Validation (CSV), Control System, Project Management, Regulatory Policies, Remediation, Risk Assessments, Software as a Service (SaaS), Software Development Life Cycle (SDLC), Stakeholder Management, Strategic Thinking

 Preferred Skills:

Job Posting End Date:

10/11/2025

*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:R362477