Project Engineer Validation
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Our client, a leading pharmaceutical company, is seeking a professional to manage product and project lifecycles within their technical services department. The role focuses on providing end-to-end validation support and managing quality investigations to ensure seamless production and new product introductions.
- Manage the introduction and qualification of Single Use Systems (SUS) materials and filters for new products.
- Lead cleaning validation activities, including the determination of validation approaches and execution of tests in production.
- Execute sterilization validation projects across various techniques such as autoclave, VHP, and SIP.
- Perform urgent quality investigations and conduct risk assessments to support site technical activities.
- Prepare and maintain GMP documentation and master batch records for project compliance.
- Implement technical changes and assess deviations related to manufacturing systems and materials.
- You have a Master’s degree in Bio-engineering, Pharmacy, Biochemistry, or Biotechnology.
- You bring 3+ years of experience in executing validation projects and coordinating technical planning.
- You possess a strong background in a GMP environment, specifically with risk assessment and deviation management.
- You have expertise in validation including cleaning validation, sterilization validation, and Single Use Systems.
- You're an organized, analytical, and proactive individual with strong technical writing and problem-solving abilities.
- You are fluent in Dutch with a good knowledge of English.
Nice to Haves
- Experience designing and maintaining master batch records.
- Willingness to work in a shift system for specific project requirements.
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