Functie

Employer is an international player in the of pharmaceutical products with locations in the United States, United Kingdom, the Netherlands and Belgium. Employer in Belgium (Hamont-Achel) is responsible for assembling, labeling and pre-filled syringes, injection pens and vials. At Employer 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, NO,..) Implements these technologies as required at Employer by collaborating with the wider Employer organization Embeds sterilization technologies in the operational framework existing at Employer Ensures that adjacent (medical device or combination device assembly and ) operations can occur concurrent with the sterilization technologies and ensures compliance with pharmaceutical regulatory requirements (eg. Eudralex Annex ), 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 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 Employer, 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
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