CSV Engineer

DE  ‐ Vor Ort
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Beschreibung

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.
Start
ab sofort
Dauer
3-6 months
Von
Quanta Consultancy Services
Eingestellt
01.06.2016
Projekt-ID:
1139918
Vertragsart
Freiberuflich
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