Functie

Sharp is an international player in the packaging of pharmaceutical products with locations in the United States, United Kingdom, the Netherlands and Belgium. Sharp in Belgium (Hamont-Achel) is responsible for assembling, labeling and packaging pre-filled syringes, injection pens and vials. At Sharp you will join a growing international company that contributes to the quality of life of patients worldwide.

The person we are looking for 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.

Jouw profiel

• 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

• Het plan, de fases en de acties van kwaliteitsopvolging ontwikkelen en uitvoeren
• De personeelsleden bewustmaken van en opleiding geven over de benadering van kwaliteit
• Technische ondersteuning en advies geven aan diensten en klanten (ontwerp, uitwerking, ...)
• Kwaliteitsgegevens opvolgen en analyseren
  Veranderingen en verbeteringen bepalen
• Kwaliteitsprocedures uitwerken en aanpassen en de correcte toepassing controleren
• Documentatiemateriaal voorzien, beheren en actueel houden
• Gevallen van non-conformiteit analyseren
  Corrigerende acties bepalen en aanbevelen

Aanbod

At Sharp, we strive to create a work environment where all employees can make the most of their skills. We offer you a versatile and challenging position in a dynamic working environment and we create numerous career opportunities. You can count on a suitable salary that is supplemented with numerous benefits, such as group and hospitalization insurance, meal vouchers, gift vouchers and other benefits.

Solliciteren

Bram Weckx
+32 499 70 17 25
bram.weckx@sharpserviceseu.com