Sterilization Technologist
Short Description
Our client is a leading provider of pharmaceutical packaging solutions, specializing in advanced and innovative services to meet the needs of the pharmaceutical industry. Committed to delivering the highest quality standards, they support clients globally with a range of services, from packaging design to serialisation and clinical trial solutions. With a focus on precision, safety, and compliance, they are trusted worldwide to ensure the utmost quality in each step of the packaging process.
Requirements
• 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
Benefits
We strive to create a working environment in which all employees can make the most of their skills. We offer you a versatile and challenging position in a dynamic workplace and provide numerous opportunities for growth. You can count on a competitive salary complemented by a wide range of benefits, such as group and hospitalization insurance, meal vouchers, gift vouchers, and other perks.
