Computer Validation and Quality Lead

Job Description

Join our dynamic IT team as a Computer Validation and Quality Lead and drive excellence in a collaborative environment! Apply now and embark on an exciting journey where your contributions will make a real difference!

For our Animal Health location in Boxmeer (The Netherlands) we are currently recruiting a Computer Validation and Quality Lead.

Welcome to the team

Global Animal Health Manufacturing IT Boxmeer delivers and supports IT, automation and laboratory solutions to the manufacturing sites Boxmeer and De Bilt. This encompasses a wide range of manufacturing and laboratory technologies, including MES, PLC, SCADA, LIMS, ELN, lab instruments and supporting IT applications, all aligned to a goal of ensuring frictionless flow of data and more efficient business operations.

Purpose of the role

You will have the opportunity to drive the Computer System Validation (CSV) and Quality services across the various project and operations teams at the Boxmeer and De Bilt sites. Besides contributing CSV and Quality services to projects, you will also be responsible for developing the CSV competence and will provide oversight and guidance to the CSV analysts in the area teams. You will work closely with the Business Technology Partners to ensure the right level of CSV and Quality services are delivered according to the AH Quality Management System. You will report to the Site Digital Manufacturing Operations Lead.

Primary responsibilities

• Drive standardization in computer validation and testing methodologies and procedures across project and operational teams based on global standards.
• Support the project managers in scheduling process with clear milestones, resource plan, deliverables and dependencies.
• Support the development of audit responses and engages with local quality organizations on proper strategies when required.
• Responsible for identifying and engaging in remediation of site IT and automation compliance risks.
• Lead execution of risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies.
• Responsible for reporting challenges in execution or adherence to procedural trends due to nonconformance and accountable for the effective and efficient running of all compliance operations in the site IT and automation team.
• Responsible for reporting status for site deviations / CAPAs and other quality records that will be used as indicators of control and conformance to policy.
• Responsible for communication and championing changes to the computer systems validation policies and procedures.
• Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to company policies and procedures.
• Ensure and promote collaboration with global Foundational Services team, IT teams at other sites and divisions as well as parts of our manufacturing network, both locally and globally, to break-down organizational boundaries in favor of a highly collaborative and customer-centric culture.

Your profile

• Bachelor’s degree with relevant experience in Computer Science, Computer Science Engineering or equivalent experience.
• At least 5 years’ experience in a highly regulated manufacturing environment, such as pharma, biotechnology, food or chemicals.
• At least 3 years of proven CSV experience.
• Proficient and demonstrated knowledge of regulatory GxP requirements (21CFR part 11, EMEA Annex’s 11, etc) that apply to computerized systems validation and compliance for site based solutions, as well as an understanding of divisional and enterprise systems.
• Working knowledge and application of ISA S95 and S88 Standards in GxP environment preferred.
• Effective interpersonal and communication skills, both verbal and written in English and preferable in Dutch.
• Currently living near the site in Boxmeer, Netherlands. Relocation support is not offered.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance;
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Annual bonus based on own and company performance;
• Travel allowance for commuting;
• Numerous training, coaching and e-learning modules for long term job opportunities and development

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/31/2025

*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: R336987