Change Control Specialist

Progressive; Haarlem; On-site; EUR 65,000 - 95,000; Full time

Job summary

Progressive is seeking a Change & Commissioning Engineer to support capital projects at a major pharmaceutical site in Haarlem. The role focuses on initiating, coordinating, and closing changes within quality and safety systems to ensure GMP compliance, with emphasis on change control and Veeva-based processes.

You will also assist with commissioning activities for facility assets, including HVAC, electrical, flooring and safety systems, working closely with Quality, Engineering and Operations

Qualifications

• Bachelor's degree in Engineering, Life Sciences or Pharmaceutical Technology.
• Experience in a GMP-regulated environment.
• Strong Change Control experience and impact assessments.
• Familiarity with Quality Management Systems, preferably Veeva.
• Understanding commissioning activities in facility, utility or infrastructure projects.

Responsibilities

• Manage change controls from initiation through implementation and closure within quality and safety management systems.
• Perform impact assessments to evaluate effects 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.

Skills

Change management

Stakeholder management

GMP compliance

Quality systems

Education

Bachelor's degree in Engineering, Life Sciences or Pharmaceutical Technology

Tools

Veeva

Job description

Location: Haarlem, Netherlands

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.

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

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