- Qualification and Validation activities for production equipment and/or processes
- Creation of qualification plans/reports for DQ, IQ, OQ, PQ, SAT, FAT
- Creation of specifications (URS) and risk analyses (FMEA)
- Creation and review of the Validation Master Plan (VMP)
- Ensuring quality standards in the area of equipment/plant construction
- Application of appropriate quality standards (GMP)
- Innovative & Continuous Improvement
- Operational handling of Change Controls, CAPAs, and Non-Conformities
- Internal and external stakeholder management
- Bachelor, Master's diploma, Ph.D. or equivalent in biotechnology, pharmaceutical, medical technology, or related field
- A minimum of 1 year of extensive work experience in the CQV (Commissioning, Qualification & Validation) sector
- Know-how of Qualification & Validation requirements
- Professional experience in a GMP-regulated environment
- Fluency in English and German
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Qualification & Validation Engineer (LIFE SCIENCES) - Bern, Schweiz - agap2 - HIQ Consulting
Beschreibung
agap2 is a dynamic and rapidly growing company and employs more than 9000 people in 14 European countries. With more than 200 employees in Switzerland, we are specialized in Life Science, MedTech, Pharma, BioTech, etc. Our offices in Switzerland are located in Basel, Zürich, and Lausanne
agap2 works successfully in all areas of the product life cycle, including Research & Development, Quality Management, Regulatory Affairs, Production, and Commercialization.
agap2 offers a permanent contract for highly qualified specialists with a background in engineering and life sciences for operative industry projects.
Tasks
Requirements
Benefits
You will have a technical manager at your side who will accompany, support, and prepare you for the next step of your career at agap2. Furthermore, you can expect a collegial team in a dynamic working atmosphere, extensive development opportunities, and the prospect of quickly taking on responsibility and actively shaping the future of the company.
