CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’800 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the US offers flexible and specialized solutions across six technology platforms: Peptides, Oligonucleotides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

As soon as possible, at Fribourg site, we are looking for a

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

• 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)