Introduction

CordenPharma est une organisation leader dans le développement et la fabrication, sous-contrat (CDMO), d'ingrédients pharmaceutiques actifs (API), d'excipients, de produits pharmaceutiques et de conditionnement. Avec plus de 2800 employés au travers le monde, nos services permettent aux entreprises pharmaceutiques et biotechnologiques de fabriquer des médicaments dans le but d'améliorer la vie des personnes.

Notre réseau en Europe et aux États-Unis offre des solutions flexibles et spécialisées via six plateformes technologiques : Peptides, Oligonucleotides, lipides et hydrates de carbone ; injectables ; oncologie et petites molécules. A CordenPharma, nous visons l'excellence en soutenant ce réseau et en nous engageant à fournir des produits de la plus haute qualité pour le bien-être des patients.

Pour notre site de Villars-sur-Glâne (Fribourg, Suisse), nous cherchons, dès que possible un(e) : 

Qualification & Process Engineer (m/f/d) 100%
Villars-sur-Glâne, Fribourg

  • Fribourg
  • ASAP
  • Temps plein
  • Durée indéterminée

Vos tâches :

As Qualification & Process Engineer you will be working as part of the CordenPharma Fribourg Technical Operations Department. You will manage the qualification plan to maintain the accurate qualification state of new and existing equipments for Manufacturing, Packaging & Engineering. 

  • Qualification of equipments : you will execute and monitor the qualification status of the new and existing manufacturing, packaging & engineering equipments and systems, manage the whole process of qualification plan (URS/DQ/FAT/SAT/IQ/OQ/PQ) & create qualification, risk analysis, technical &SOPs documentation
  • Improvements: You will lead or participate to investigations, improvements and customers requests implementation for equipment and systems under your responsibilities.
  • Leadership : You will manage external resources (equipment suppliers) and project teams
  • Quality: you will ensure the quality of Qualification activities activities according to GMP guidelines, VMP and internal procedures
  • Process: Lead the investigation for deviations linked to equipment and production processes using problem-solving tools and define corrective actions
  • Projects: Lead or participate to the implementation of continuous improvement projects for manufacturing and packaging equipment and processes

Votre profil :

  • Engineering degree, Master of Science, in relevant field (Pharmaceutical industry, Chemistry)
  • Min.3 years’ experience with equipment qualification
  • Experience with GMP and FDA regulations
  • Excellent interpersonal skills, analytical thinking and cost consciousness, great communication skills
  • Experience with computer validation (GAMP, 21CFR Part 11, Eudralex Annex 11) & Data Integrity
  • Strong oral & written communication skills (English & French; German a plus)
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