Beschreibung
A global biotech organisation is looking for 3 x C&Q Engineers (German Speakers) for a 3 month contract role based in south of Switzerland.The plant is an existing manufacturing site that will now also manufacture a new biotech product which is currently in Phase III clinical trials. The project has an aggressive schedule until the end of September close out to meet an FDA deadline.
Phases of the project:
- The current CQ team is focused on the new equipment being installed this is under control and should be completed by end of May / Also the complete system review has already taken place.
Parallel Team
- They must now set up a team to review the existing equipment onsite and complete remediation work as required. To ensure GDP / GMP / FDA standards are met.
- IQ/OQ/PQ
- Documentation is mostly in German for the old systems -and the Qualification summary reports are in English. - It is beneficial here to have a German / English speaking person for the review FDA documents.
Ideal Back ground of people:
- Process / Chemical Engineering
- GMP / FDA / GDP
- Biopharma
- Previous experience with remediation projects
- Documentation Review / German - English
- IQ/OQ/PQ
- Commissioning / Qualification
- Solid dose / pharma is possible
- German speaker!
Upstream Equipment experience:
- Fermentors
Downstream Equipment experience:
- Purification
- Filtration
- Ultra filtration