Process Validation Engineer Cell Therapy
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Our client, a leading biotechnology organization, is seeking a professional to support the start-up of a new production facility. The project focuses on technical transfers, sterilization validation, and equipment introduction to expand therapeutic manufacturing capacity. This role ensures that all manufacturing processes are developed and validated according to the highest industry standards.
Responsibilities
- Define strategies and coordinate validation activities including PPQ, smoke studies, hold time validation, and APS.
- Provide technical guidance on all aspects of validation and qualification for the manufacturing site.
- Manage the revalidation of manufacturing and sterilization processes to ensure continuous compliance.
- Draft, review, and approve validation plans, protocols, and reports for APS and sterilization procedures.
- Contribute to product transfer and system introduction teams to facilitate site development.
- Lead system and process improvement projects focused on operational optimization.
- Monitor technical reports to ensure procedures align with current cGMP and regulatory requirements.
Requirements
- You have a Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, or pharmacy.
- You bring experience in the pharmaceutical or biotechnology industry, specifically with product introductions and manufacturing unit operations.
- You possess a strong working knowledge of cGMP and validation methodologies.
- You have experience in project management and the ability to provide accurate reporting on project activities.
- You're a proactive team player with strong problem-solving skills and the ability to work under pressure and manage priorities.
- You are fluent in Dutch and English.
Nice to Haves
- Experience working in a controlled cleanroom environment under aseptic conditions.
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