Description
Our biopharmaceutical manufacturing client has undertaken a large expansion of its manufacturing facilities to allow for its first commercial production runs. They are currently looking for a CSV Engineer to support them during the upgrade of their fermenter control systems.Responsibilities:
Fermenter Control System upgrade project:
- Review SAT documentation from the vendor.
- Attend the SAT and witness SAT tests.
- Create IQ/OQ protocols and reports.
- Work closely with the vendor through the implementation and coordinate CSV activities.
- Facilitate the resolution of deviations.
Requirements:
- Extensive previous experience as a CSV Engineer within the Pharmaceutical/
Bio-pharmaceutical industry, essential. - Experience with Siemens PLC and SCADA systems is necessary.
- Knowledge and experience of Siemens WinCC.
- A thorough knowledge of GAMP5 and 21 CFR Part 11 requirements.
- Previous experience of supporting FAT/ SAT, including attendance, documentation review and writing of reports.
- Ability to communicate effectively with diverse stakeholders from QA, Manufacturing and Engineering departments.
- A self-motivated individual and strong team mentality required. A proactive approach to problem solving is desired.