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. If you are interested and want to apply, please submit your application via the apply button below and contact me.
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.