Associate Director Engineering and Qualification

4 weken geleden

Haarlem North Holland Netherlands, NL Talentmark Voltijd

Associate Director Engineering and Qualification


Our client is a global leader in medicines, committed to making healthcare more affordable and accessible, impacting millions of lives daily. We are seeking an Associate Director Engineering & Qualification. In this role you will be responsible for ensuring the effective engineering management and qualification of all systems, facilities, and equipment at the site. You will ensure that all engineering activities comply with internal policies, industry regulations, and quality standards. Also you will oversee qualification activities for capital projects, manage site engineering operations, and lead cross-functional teams to ensure compliance and performance optimization. A summary of the position (a full job description is available)


  • Site Engineering Leadership: Lead the engineering team in designing, installing, and maintaining infrastructure, utilities, and facilities while ensuring compliance, safety, and operational efficiency. Oversee critical systems and resolve site issues promptly.


  • Qualification Oversight: Manage equipment, facility, and system qualifications per cGMP, FDA, and ISO standards. Develop and review qualification protocols, oversee CQV activities, and ensure timely documentation.


  • Project Management: Execute site engineering projects on time, within budget, and per regulations. Oversee CAPEX planning, system design, deviations, and CAPAs for life cycle management.


  • Cross-Functional Collaboration: Work with operations, QA, regulatory, and production teams to align qualification and compliance strategies. Support audits and regulatory inspections.


  • Compliance & Risk Management: Ensure engineering activities meet FDA, EMA, and other regulations. Assess and mitigate risks, acting as an SME in audits and inspections.


  • Continuous Improvement: Drive efficiency, quality, and safety by implementing best practices and process improvements.


  • Team Management: Recruit, train, and mentor engineers, ensuring they have the skills and resources to meet site objectives.


Your experience and qualifications

  • Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical, Industrial, or related discipline)
  • Professional certifications or training in project management, qualification/validation (e.g., ASQ, Six Sigma) are highly desirable.
  • Strong experience in engineering, with some years in a leadership role overseeing site engineering and qualification.
  • Experience with regulatory requirements such as cGMP, FDA, ISO, or similar standards in a manufacturing or regulated environment.
  • English is mandatory, Dutch is a plus - 40 hours availability to work on site
  • Proven experience in qualification and validation of equipment and facilities.
  • Strong background in project management, with the ability to lead large-scale engineering projects from start to finish.
  • Strong leadership and team management abilities.


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