Qualification & Process Engineer (m/f/d) 100%
CordenPharma is one of the leading Contract Development and Manufacturing Organizations (CDMO) and develops and produces active pharmaceutical ingredients, medicines and associated packaging services on behalf of its customers as a “full-service” service provider. The group employs around 3,000 people.
Our network in Europe and the USA offers flexible and specialized solutions across five technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology and small molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the benefit of patients.
CordenPharma International (CPI) acts as the management company of the CordenPharma Group. In addition to the Executive Leadership Team, CPI has central functions such as Sales & Marketing, Legal, HR and Corporate Development, which work for the CordenPharma Group across locations and at an international level.
We are looking for one as soon as possible
Villars-sur-Glâne, Fribourg
- Fribourg
- ASAP
- Full-time
- Permanent
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)
Brandt, Raphael
