CSV Engineer (Life Sciences)
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.
The CSV engineer is in charge of ensuring the validated state of computerized systems on
manufacturing site, including laboratory equipment.
- Create the requested CSV documents: risk analyses, traceability matrixes, validation protocols.
- Organize the review of the CSV documents by the QA teams.
- Execute the CSV test and support the CSV timelines.
- Write CSV reports.
- Work in close collaboration with the CSV and CQV lead Engineers.
- Interact closely with Process Engineers, Automation Team (EMR), PM and QA.
- Ensure GAMP5 compliance, follow the ASTM guidelines.
Your profile:
- You hold an engineering diploma in Biotechnology, Bioprocess or Chemical Engineering, or similar.
- You have a Minimum of 3+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects.
- You have Expertise in automation and vertical integration as well as data management under validated computer systems.
- You know planning CQV activities, leading large senior reports.
- You 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.
- You are fluent in French and English.
Place of work
Berne
3000 Berne
Contact
Aleksandra Waszak
+41 78 323 03 87
Write an email
