Associate Director Engineering and Qualification (9452)
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Associate Director Engineering and Qualification (9452)
- Posted 19 February 2025
- Salary €40.63 per hour
- LocationHaarlem
- Job type Temporary
- DisciplineLife Science Recruitment
- ReferenceTR/076419
- Contact NameTim Browaeys
Job description
Orion Group Life Sciences are looking for an Associate Director Engineering and Qualification for our Pharmaceutical client based in the Haarlem Area. Initial 12-month contract. For the right candidate this could be Temp to Perm after 6 months. This is a fully onsite role.
What will you do
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.
Desired Experience and Background of the successful candidate
#opportunity #multinational #pharmaceutical #associate #director #engineering #qualification #cGMP #FDA #ISO #manufacturing #validation # equipment #facilities #projectmanagement #projectteammanagement
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
What will you do
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.
Desired Experience and Background of the successful candidate
- 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.
#opportunity #multinational #pharmaceutical #associate #director #engineering #qualification #cGMP #FDA #ISO #manufacturing #validation # equipment #facilities #projectmanagement #projectteammanagement
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.