- Creation of specifications (URS) and risk analyses (FMEA, FRA)
- Creation and review of the Validation Master Plan (VMP)
- Participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP requirements
- Participate in commissioning at suppliers (FAT)
- Participate in commissioning on customer site (SAT)
- Perform installation and operational tests (IQ/OQ/PQ)
- Work under the supervision of a Lead Validation
- Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector
- Having a sustainable job with stability and access to a real collaboration
- Benefit from training with accredited and certified centers
- Having a local management team to support you in the achievement of your missions and in the development of your career
- Being part of a dynamic, committed team with real human values that we live by every day
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Qualification Engineer - Basel, Schweiz - agap2 - HIQ Consulting
Beschreibung
agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.
As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.
You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client's portfolio.
Tasks
Contribute to the integration of new production equipment and utilities in a biotech/pharma environment:
Requirements
• Diploma in Life Sciences or Engineering, or similar
• 2-6 years of years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech environment
• Experience with DeltaV (Emerson) preferred
• cGMP knowledge and knowledge of regulatory requirements
• Fluent English and German
Benefits
Joining a group with strong development potential that aims to improve your employability on challenging and varied projects
Only applications from Swiss and EU citizens will be considered.
Engineering Consulting in the fields of Life Science, Automation, Energy, Railway, Construction with Offices in Zürich, Basel und Lausanne
