Functieomschrijving

Project Lead Engineering (GMP)

Freelance or Contract

About the Role

As a Project Lead Engineering, you will take the lead in driving complex engineering projects from concept to completion within a GMP-regulated pharmaceutical environment. You will oversee activities related to drug substance and drug product manufacturing, ensuring that all engineering work is executed safely, efficiently, and in full compliance with Good Manufacturing Practices.

In this role, you will coordinate multidisciplinary teams, collaborate closely with internal and external stakeholders, and deliver high-quality engineering solutions that support production reliability, quality, and continuous improvement.

Key Responsibilities

1. Project Leadership

• Lead and manage multiple engineering projects from initiation to completion, including planning, budgeting, scheduling, and execution.
• Collaborate with internal project teams or work independently depending on project size and scope.
• Manage a variety of engineering projects such as:
• Cleanroom reconstructions
• Capacity expansions
• Efficiency and technical upgrades
• Tech transfers and other large multidisciplinary initiatives

2. GMP Compliance

• Ensure all engineering activities fully comply with GMP, FDA, EMA, and other applicable regulations.
• Maintain accurate and comprehensive project documentation for audit readiness, traceability, and regulatory compliance.
• Independently write and review GMP documentation, including change controls and qualification documents.

3. Technical Leadership

• Provide expert engineering guidance on the design, installation, qualification, and commissioning of new equipment and systems.
• Ensure all systems and processes meet Good Engineering Practices and GMP standards.

4. Stakeholder & Vendor Management

• Communicate project status, issues, and risks clearly to senior management and other stakeholders.
• Facilitate strong collaboration across departments such as Production, Quality Assurance, and Regulatory Affairs.
• Prepare and deliver detailed project reports and presentations.
• Oversee and coordinate activities performed by external vendors and contractors.
• Negotiate and maintain strong relationships with vendors delivering critical project components.

Who You Are

You are an experienced engineer with strong project management skills and the ability to navigate complex technical and regulatory environments. You excel at leading multidisciplinary teams, managing stakeholders, and ensuring high-quality project execution in a GMP setting.