About the Role
For a major pharmaceutical manufacturing site in Haarlem, we are looking for a Change & Commissioning Engineer to support capital projects within a highly regulated GMP environment.
The primary focus of this role is change management. You will be responsible for initiating, coordinating, assessing, and closing changes within quality and safety systems, ensuring compliance with established procedures and regulatory requirements. Experience with Veeva is highly preferred, as this is the primary system used on site.
In addition, you will support commissioning activities for facility-related assets, including HVAC, electrical systems, flooring, ceilings, walls, and fire safety systems. However, the technical commissioning aspect is secondary to the change management and compliance responsibilities.
This role requires strong stakeholder management, project coordination, and the ability to operate effectively between project teams, quality departments, and operational stakeholders.
Key Responsibilities
- Manage change controls from initiation through implementation and closure within quality and safety management systems
- Perform impact assessments to evaluate the effect of proposed changes on quality, compliance, safety, validation status, and operations
- Ensure all changes are executed in accordance with GMP requirements and internal procedures
- Coordinate with Quality, Engineering, Operations, and Business stakeholders throughout the change lifecycle
- Drive change management activities within capital project environments
- Support commissioning and handover activities for facility and infrastructure assets
- Track actions, timelines, documentation, and closure requirements to ensure project compliance
- Act as a key link between project teams and the site organization
Required Experience
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Technology, or a related field
- Experience working in a GMP-regulated environment
- Strong experience with Change Control processes and impact assessments
- Experience working within Quality Management Systems, preferably Veeva
- Understanding of commissioning activities within facility, utility, or infrastructure projects
- Strong project coordination and stakeholder management skills
- Fluent in English
Preferred Experience
- Experience supporting capital projects within pharmaceutical manufacturing
- Knowledge of GMP change management processes
- Experience working with safety management systems
- Familiarity with facility assets such as HVAC, electrical, fire safety, walls, ceilings, or building infrastructure