Manufacturing Science & Technology (MSAT) Engineer, Hoofddorp, Noord-Holland

The Company:
Our client is a big biopharmaceutical company focused on making new cancer treatments. They use the body's natural defenses to fight cancer cells and want to improve how patients feel. They're trying new ideas to change cancer treatment and give hope to people everywhere.

Role Description:
We are seeking a Manufacturing Science & Technology (MSAT) Engineer to join the Manufacturing Operations and Compliance Support (MOCS) team. This role is responsible for investigating deviations, implementing process improvements, and ensuring compliance within a GMP-regulated cell therapy manufacturing environment.

Responsibilities:

• Conduct root cause investigations using structured analysis tools.
• Develop and implement CAPAs to address process deviations and ensure effectiveness.
• Collaborate with cross-functional teams to revise SOPs, batch records, and operational documents.
• Identify and escalate compliance gaps in the manufacturing process.
• Support continuous improvement initiatives to enhance operational efficiency.
• Assist in internal and external GMP audits.
• Perform additional duties as assigned.

• 2-3 years of experience in a GMP manufacturing environment.
• Background in cell culture, cell therapy, or aseptic processing.
• Strong understanding of cGMP compliance, deviation investigations, and change controls.
• BSc in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field (Engineering degree is a plus).
• Excellent communication skills and ability to work in cross-functional teams.
• Strong technical writing skills with experience in protocol/report writing.

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