Associate Director Engineering and Qualification (9452)

Associate Director Engineering and Qualification (9452)

Posted 2 days ago by Orion Group

Negotiable
Undetermined
Onsite
Haarlem

Summary: Orion Group Life Sciences is seeking an Associate Director of Engineering and Qualification for a pharmaceutical client in the Haarlem area. This fully onsite role involves leading site engineering teams, overseeing qualification processes, and managing engineering projects to ensure compliance with regulatory standards. The position is initially a 12-month contract with the potential for a temp-to-perm transition for the right candidate.

Key Responsibilities:

  • Manage and lead the site engineering team, ensuring compliance with engineering standards and operational efficiency.
  • Lead and manage the qualification process for new or modified equipment and facilities in accordance with regulatory requirements.
  • Execute site engineering projects on time and within budget, managing capital projects and engineering improvements.
  • Collaborate with cross-functional teams to align on qualification strategies and compliance efforts.
  • Ensure engineering activities comply with local, state, and federal regulations, participating in regulatory inspections as a subject matter expert.
  • Foster a culture of continuous improvement within the engineering team, implementing process improvements and best practices.
  • Hire, train, and develop engineers and technical staff, providing mentorship and leadership to junior engineers.

Key Skills:

  • Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related discipline).
  • Professional certifications in project management or qualification/validation (e.g., ASQ, Six Sigma) are desirable.
  • Strong experience in engineering with leadership experience in site engineering and qualification.
  • Experience with regulatory requirements such as cGMP, FDA, ISO in a manufacturing environment.
  • Proven experience in qualification and validation of equipment and facilities.
  • Strong project management skills with the ability to lead large-scale engineering projects.
  • Strong leadership and team management abilities.
  • In-depth understanding of qualification protocols and engineering best practices.
  • Ability to manage multiple priorities and work effectively under pressure.
  • Experience in regulated industries, particularly pharmaceuticals, biotech, or medical devices.

Salary (Rate): 35.00

City: Haarlem

Country: Netherlands

Working Arrangements: on-site

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other