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水平: Mid-Senior level
工作类型: Full-time
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工作内容
Position
Is subject matter expert in the field of sterilization; supporting running commercial sterilization processes, as well onboarding new sterilization programs and new sterilization technology.
- Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) sterilization technologies (VHP, EtO, NO2,..)
- Implements these technologies as required at Sharp by collaborating with the wider Sharp organization
- Embeds sterilization technologies in the operational framework existing at Sharp
- Ensures that adjacent (medical device or combination device assembly and packaging) operations can occur concurrent with the sterilization technologies and ensures compliance with pharmaceutical regulatory requirements (eg. Eudralex Annex 1),
- Understands the full sterilization cycle and all the parameters influencing the sterilization process,
- Leads Investigations of non- conformities occurred during sterilization cycles and apply expertise to resolve these issues with the wider team
- Optimize production processes linked with the sterilization processes to allow for smooth batch sterilization (and adjacent) processes,
- Supports commercial discussions with new/existing clients in the field of sterilization.
Profile
- Scientific Master degree preferably in Bioscience engineering.
- Knowledge and experience of (aseptic and/or) sterilization technologies through education, industry experience and/or training
- Good knowledge of microbiology of food and/or pharma
- Experience in a cGMP environment and/or Annex 1 is a pro
- Fluent in Dutch and English
- Entrepreneur/Ownership
- Analytical thinking
- Accurate
- Capability to communicate efficiently and effective about issues of a complex (technological and scientific) nature
- Attention for detail
- An urge to know the science behind the technology
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最后期限: 31-12-2025
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