Change Engineer

Change & Commissioning Engineer (Capital Projects)

Location: Haarlem, Netherlands

Contract: 6-month assignment (extension might be possible)

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

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