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Computerised System Validation Lead

Haarlem, Netherlands

Job Description

Do you want to make an important contribution to the validation optimalization for our Haarlem site? Do you want to work in a dynamic operational environment and are you ready for a new challenge? Then we are looking for you!

For our Global Digital Foundational Services team, we are looking for a Computerized System Validation Lead.

The team

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. In this young and growing team, you will report into the Director of Compliance EMEA.

The position
Computerized System Validation Lead is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities.


Primary Responsibilities:

  • ​Lead and/or support various site functional and cross functional structures for all computerized system validation and IT/OT compliance issues.
  • Responsible for representing compliance activities to internal and external auditors / agencies
  • Supports the development of audit responses and engages with local quality organizations on proper strategies when required.
  • Responsible for Identifying and engaging in remediation of IT/OT compliance risks.
  • Execute 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 Automation and IT teams.
  • Responsible for reporting status for local / site-based 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 SDLC policies and procedures at the site
  • Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within Digital Manufacturing Division.
  • Liaise with Compliance teams from other sites to ensure consistency and best practices applied.

Your profile

  • Bachelor’s degree in computer science, Engineering, Regulatory compliance or a related study
  • 3+ years supporting compliance activities.
  • Proficient and demonstrated knowledge of regulatory requirements (21CFR part 11, EMEA Annex’s 11, etc) that apply to computerized systems validation and compliance for site based as well as divisional and enterprise systems.
  • Demonstrated ability to manage internal and external auditors / agencies.
  • Working knowledge and application of ISA S95 and S88 Standards in GxP environment.
  • Working knowledge of how to validated / qualify Cloud, SaaS, modern analytics and data integration architecture platforms and components.
  • Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing, Quality, and Supply chain.
  • Demonstrated ability to partner with stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.
  • Outstanding written and verbal communication skills – able to effectively communicate complex concepts in simple ways.
  • Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide.
  • Results-orientation with the proven ability and reputation for developing plans and implementing them successfully.
  • Technical, operational and business expertise in the following disciplines: Computer Systems Validation, Instrumentation/Automation & Control, Project Management.

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 or a lease car;
  • 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:

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID: R272055

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