Key Skills

Job Description

The Company Our client is a leading global biopharmaceutical company dedicated to discovering, developing, and manufacturing innovative medicines that improve patients’ lives. With a strong focus on quality, safety, and operational excellence, the organization continuously invests in advanced manufacturing facilities, engineering projects, and infrastructure improvements within a highly regulated environment. Job Description As a Change Control Engineer, you will manage change control processes and impact assessments within quality and safety systems to support capital projects in a regulated manufacturing environment. You will collaborate with Quality, Business and Engineering stakeholders while supporting the commissioning of GMP and non-GMP facility assets, including HVAC, electrical systems and building infrastructure. Responsibilities Manage and coordinate change-control processes within quality and safety management systems in a regulated manufacturing environment. Conduct pre-assessments and impact assessments to evaluate proposed changes affecting GMP systems, safety and technical assets. Support commissioning activities for facility infrastructure, including HVAC, utilities, electrical systems, flooring, ceilings, walls and fire safety systems. Collaborate with Quality, Engineering, Safety and technical stakeholders to gather information, coordinate assessments and ensure timely approvals. Maintain accurate change-control documentation and ensure changes are properly tracked, implemented and closed. Support multiple ongoing capital projects while ensuring compliance and safe operations within a live manufacturing environment. Requirements Proven experience in change management or change control, preferably within a pharmaceutical, biotech or other GMP-regulated environment. Experience with quality and safety management systems; familiarity with Veeva is highly desirable. Knowledge of impact assessments, risk assessments and change-control documentation. Technical understanding of commissioning, facilities, utilities, engineering assets or fire safety is an advantage. Strong stakeholder management, communication and organizational skills, with the ability to work independently and proactively. Fluent English is required; Dutch language skills are an advantage. Other Information Apply to our vacancy for more information. We look forward to hearing from you!

Core Responsibilities

Manage change-control processes and conduct impact assessments for proposed changes affecting GMP systems, safety, and technical assets. Support commissioning of facility infrastructure and coordinate with Quality, Engineering, Safety, and other stakeholders to document, implement, and close changes across capital projects.

Requirements

Experience in change management or change control is required, preferably in a pharmaceutical, biotech, or other GMP-regulated environment, along with familiarity with quality and safety systems and impact assessments. Technical knowledge of commissioning, facilities, utilities, engineering assets, or fire safety is advantageous; strong communication and organizational skills and fluent English are required, while Dutch is an advantage.