Information
- Location: Berne, Suisse
- Position: CSV Engineer (Computer system validation)
- Sector: Life Science
- Type of contract: Permanent contract
- Starting date: ASAP
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.
Your main missions are:
- Being in charge of ensuring the validated state of computerized systems on a manufacturing site, including laboratory equipment.
- Creating the requested CSV documents: risk analyses, traceability matrixes, validation protocols.
- Organizing the review of the CSV documents by the QA teams.
- Executing the CSV test and supporting the CSV timelines.
- Writing CSV reports.
- Working in close collaboration with the CSV and CQV lead Engineers.
- Interacting closely with Process Engineers, Automation Team (EMR), PM and QA.
- Ensuring GAMP5 compliance, following the ASTM guidelines.
This job is made for you if...
…You
- hold an engineering diploma in Biotechnology, Bioprocess or Chemical Engineering, or similar.
- have a Minimum of 3+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects.
- have expertise in automation and vertical integration as well as data management under validated computer systems.
- know planning CQV activities, leading large senior reports.
- have a proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- are fluent in English (German is a big advantage)
Working with us means...
- Joining a group with strong development potential that aims to improve your employability on challenging and varied projects
- Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes the 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 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
Only applications from Swiss and EU citizens will be considered. Please note that due to Brexit we are no longer accepting applications from the UK.