Join a pioneering biotech company at the forefront of cell therapy innovation. As an Associate Engineer GMP Operations, you'll be integral to the MSAT team, focusing on Manufacturing Operations and Compliance Support. Engage in deviation investigations, CAPA development, and cross-functional collaboration to enhance T-cell therapy production. Enjoy a dynamic work environment with opportunities for professional growth and contribute to transformative therapies that impact patient lives. Read on to see how your skills fit this role.

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SIRE Life Sciences

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The Company
Our client is a pioneering biotech company leading the way in cell therapy, with a cutting-edge manufacturing facility located in Hoofddorp. Committed to transforming patient lives through advanced therapies and innovative science, the company fosters a highly collaborative and forward-thinking environment. This is an exciting opportunity to become part of a driven team developing breakthrough treatments in a rapidly growing and dynamic industry.

The Role
We are looking for an Associate Engineer GMP Operations to join the MSAT (Manufacturing Sciences and Technology) team, with a focus on Manufacturing Operations and Compliance Support (MOCS). In this role, you will play a key part in driving continuous improvement and maintaining compliance within the production of T-cell therapy products. Your responsibilities will include hands-on involvement in deviation investigations, CAPA development, and documentation, while working cross-functionally to support the efficient and compliant manufacturing of transformative therapies.

Responsibilities
-Conduct investigations and resolve deviations utilizing Root Cause Analysis tools
-Develop and implement CAPAs to ensure sustainable issue resolution
-Draft and update SOPs, batch records, and other essential operational documents
-Work closely with technical and operational teams to drive process improvements
-Offer hands-on support during audits and other compliance-related activities
-Carry out additional responsibilities as assigned by management

Requirements
-BSc in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field
-2–3 years of experience in a GMP pharmaceutical or biotech manufacturing environment
-Preferred background in cell culture, cell therapy, or aseptic processing
-Experience with investigations, deviation reports, CAPAs, and change controls

Other Information
Are you interested and would you like to apply for this position? Please submit your application using the application button below and contact Zahra Souhali.

55016

Gerelateerde zoekopdrachten

Engineer Hoofddorp Fulltime Hoofddorp Vast contract Hoofddorp Hoofddorp Provincie Noord-Holland Engineer Salaris Engineer

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