Process Validation Engineer Cell Therapy - Ghent
2 weken geleden
Job summary
We are currently looking for a Process Validation Engineer Cell Therapy to join our team.Main responsibilities
Define strategy, plan, and coordinate validation activities such as sterilization, hold time validation,
Provides guidance on aspects of validations and qualifications
Assure revalidation of manufacturing and sterilization processes
Write review approve of sterilization APs Sotherelated validation plans protocols reports Participate in product transfer system introduction teams Participate in system process improvement optimization projects Reviews technical reports sources information ensure that validations procedures consistent current industry regulatory requirements technology Your profile Experience Pharmaceutical Biotechnology Cell Therapy human plasma derived products related industry required Experience introduction pharmaceutical products manufacturing sites late state development working technical knowledge manufacturing site unit operations Strong working knowledge Good Manufacturing Practices cGMP Experience controlled cleanroom environment under aseptic conditions plus but not must Project Management provide timely accurate reporting project activities peers leadership Ability interact different levels organization Ability work pressure handle conflicting interests take decisions Able work independently general direction good sense prioritization assigned tasks goals manage time accordingly Team player Problem solving skills attitude Fluent written spoken Dutch English
- A Bachelor's degree higher engineering biotech biomedical sciences pharmacy required 7 years previous experience
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