Teva Associate Director Engineering Qualification 

Netherlands, North Holland, Haarlem 

875707236

Join Teva in Haarlem (NL) as Associate Director Engineering and 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.

1. Site Engineering Leadership:

• Manage and lead the site engineering team, ensuring the design, installation, and maintenance of all infrastructure, utilities, and facilities.
• Ensure compliance with engineering standards, safety regulations, and operational efficiency.
• Oversee the operation of critical systems (e.g., HVAC, electrical, mechanical) and ensure the timely resolution of any issues affecting the site.

2. Qualification Oversight:

• Lead and manage the qualification process for new or modified equipment, facilities, and systems in accordance with cGMP, FDA, ISO, and other relevant regulatory requirements.
• Develop and review qualification protocols and reports to ensure they meet compliance standards.
• Coordinate the execution of commissioning, qualification, and validation (CQV) activities.
• Ensure timely and accurate completion of qualification documentation.

3. Project Management:

• Lead site engineering projects, ensuring that they are executed on time, within budget, and in compliance with regulatory requirements.
• Work with internal teams and external vendors to scope, plan, and implement engineering solutions that align with site goals.
• Manage capital projects and engineering improvements, ensuring they meet operational and regulatory needs.
• Overall responsibility on site’s CAPEX plan and accountable to meet the annual agreed deliverables related to cash flow and milestones of the agreed projects.
• Responsible on the systems design and generate needed support on leading deviations and CAPA’s relevant to life cycle management of all site’s systems.

4. Cross-Functional Collaboration:

• Collaborate with cross-functional teams, including operations, quality assurance, regulatory affairs, and production, to ensure alignment on qualification strategies and compliance efforts.
• Provide engineering expertise and guidance to other departments to support their initiatives, particularly during regulatory inspections or audits.

5. Compliance and Risk Management:

• Ensure engineering activities are in full compliance with relevant local, state, and federal regulations (FDA, EMA, etc.).
• Lead efforts to assess and mitigate risks related to site engineering and qualification.
• Participate in regulatory inspections and audits as a subject matter expert on engineering and qualification matters.

6. Continuous Improvement:

• Foster a culture of continuous improvement within the engineering team, focusing on efficiency, quality, and safety.
• Identify and implement process improvements and best practices in engineering and qualification activities.

7. Team Management:

• Hire, train, and develop engineers and technical staff, ensuring the team has the necessary skills and resources to achieve site objectives.
• Provide mentorship and leadership to junior engineers, helping them grow professionally.
  

• 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
• 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.
• In-depth understanding of qualification protocols, regulatory standards, and engineering best practices.
• Ability to manage multiple priorities and work effectively under pressure
• Experience working in a regulated industry, particularly pharmaceuticals, biotech, or medical devices, is highly preferred

Director Engineering and Maintenance

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