GMP Process Support Engineer, Hoofddorp

Company A leading biopharmaceutical manufacturing environment focused on advanced therapies is looking to strengthen its technical operations support. The site operates under strict GMP standards and works in close collaboration across Manufacturing, Quality, and Technical teams to ensure safe, compliant, and reliable production.

Job Description The

GMP Process Support Engineer (Cell Therapy Manufacturing)

will join a technical operations support team and help ensure smooth, compliant manufacturing and product release activities. The role focuses on impact assessments, deviation investigations, root-cause analysis, CAPA implementation, and continuous improvement in a fast‑paced aseptic processing environment.

Responsibilities

Support product release activities through technical impact assessments and documentation support

Lead and coordinate deviation investigations using structured root‑cause analysis tools

Define and implement corrective and preventive actions (CAPAs) and verify effectiveness

Create, update, and review operational documentation such as SOPs and batch records

Collaborate with cross‑functional stakeholders (e.g., Manufacturing, Quality, Technical) to deliver timely outcomes

Contribute to continuous improvement initiatives and operational projects

Perform additional duties as assigned by management based on business priorities

Requirements

Bachelor’s degree in (Bio)Chemical Engineering, Biotechnology, Biochemical Engineering, or a related discipline

Hands‑on experience with

cell culture/cell therapy

and/or

aseptic processing

Strong working knowledge of

cGMP

environments, including deviations, change controls, investigation reports, and corrective actions

Strong communication skills and ability to work effectively in cross‑functional teams

Critical thinking and practical troubleshooting/problem‑solving capability

Able to work independently and adapt quickly to changing priorities in a growing organization

Other Information The position is based on‑site in Hoofddorp, Netherlands.

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