Associate Director, Engineering - Aseptic Production Support

HRM; Fegersheim; On-site; EUR 80,000 - 120,000; Full time

Job summary

A biotech leader in France is seeking an Associate Director of Engineering to lead aseptic production support. Responsibilities include building a capable team, defining engineering priorities, and ensuring compliance with cGMP standards. The ideal candidate has an engineering degree, industry experience, and strong leadership skills. Fluent French is required for this key position in a global organization.

Qualifications

• Strong ability to form effective relationships at all levels.
• C1 French proficiency required.
• Knowledge of cGMPs and their application to manufacturing operations.

Responsibilities

• Collaborate to build an organization with necessary capabilities.
• Define engineering priorities and roadmap.
• Lead technical SMEs during regulatory inspections.
• Promote continuous improvements to reduce production downtime.

Skills

Leadership

Technical coaching

Data integrity

Compliance management

Relationship building

Education

Degree in Engineering

Job description

Overview

Join to apply for the Associate Director, Engineering - Aseptic Production Support role at HRM.

Our client is a global leader in the biotech industry, employing over 400,000 staff worldwide and generating over $30 billion in revenue in 2023 and over $45 billion in 2024. Their site in France is an integral plant in their global network and are seeking an Associate Director of Engineering who will be directly responsible for engineering support for day-to-day aseptic production, team leadership, technical coaching and management of the maintenance budget.

Responsibilities

• Serve as a collaborative, inclusive, and energetic leader to build an organization with the necessary capabilities, capacity, and culture to operate the facility to the highest standards of safety, quality, and operational excellence.
• Define the department engineering priorities and roadmap to develop and implement the required systems and processes, leveraging existing company knowledge and incorporating external experiences and learnings.
• Act as a key member of the site engineering Lead Team, ensuring a safety focus throughout project delivery and startup.
• Develop department long term perspective through organization.
• Develop and adapt the organizational structure to provide appropriate and capable resources and management, delivering the site to full GMP manufacturing scale.
• Lead technical SMEs during key regulatory cGMP inspections (FDA, ANSM, etc.).
• Promote data integrity and digitalization.
• Lead and oversee summer/winter shutdowns & drive continuous improvements of this process to reduce production downtime and be right the first time.
• Ensure compliance with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.
• Benchmark best practices across networks and externally.
• Maintain a robust control system to manage the business, identify compliance issues, and escalate issues appropriately.
• Develop future management and technical leadership for the site and potential global assignments.
• Act as a resource for staff projects.

Experience

• Degree in Engineering related discipline.
• Experience in biologics or pharmaceutical industry required.
• Previous Maintenance Engineering experience preferred.
• Knowledge and understanding of cGMPs, technical acumen, and their application to manufacturing operations.
• Strong ability to form effective relationships at all levels.
• C1 French proficiency required.

If you are interested in learning more about this opportunity, apply now or contact Anita Osibuamhe at [e-mail] or on [phone].