Requirements: English
Company: i-Pharm Consulting
Region: north holland, netherlands, netherlands , North Holland
Title: Process Engineer
Contract Duration: 12 Months
Location: North Holland, Netherlands
Do you consider yourself motivated and innovative?
If so, this role is a perfect match to demonstrate your personality and skillset. As a Process Engineer, You will be part of the Manufacturing Operations and Compliance Support (MOCS) team at our manufacturing site. Contributing to the production of cutting-edge T-cell therapy products.
Key Responsibilities
In this role, you will be responsible for root-cause investigations and continuous improvement initiatives.
Your key duties will include:
- Collaborating with technical and operational stakeholders to write and/or revise SOPs, batch records, and other operations-related documents.
- Conducting thorough root-cause investigations and coordinating the resolution of deviations using comprehensive analytical tools.
- Developing and implementing CAPAs to address root causes and ensure long-term effectiveness.
Requirements
- Prior experience in cell culture, cell therapy, and/or aseptic processing.
- Proven technical knowledge and experience with cGMP compliance, including leading investigations, writing deviation reports, managing change controls, and implementing corrective actions.
- Solid understanding of scientific and engineering principles as they apply to biopharmaceutical manufacturing.
- Self-motivated and detail-oriented, with the flexibility to take on temporary responsibilities outside of the initial job scope.
Knowledge and Experience
- BSc in Biochemical Engineering, Chemical Engineering, Biotechnology, or an equivalent field; an Engineering degree is a strong plus.
- 2-3 years of relevant process engineering experience within a Pharmaceutical/GMP Manufacturing Site.
- Strong technical writing skills, including experience with protocol and report writing.
- Excellent interpersonal skills, with the ability to collaborate across departments to achieve project goals.
Join us and contribute to the future of innovative cell therapy manufacturing!