Contract Computer Systems Validation (CSV) Engineer

Frankfurt am Main  ‐ Vor Ort
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Beschreibung

Contract Computer Systems Validation (CSV) Engineer
Frankfurt
€65 per hour
12 months

My client is a large Pharmaceutical company, ho thanks to recent expansion, are looking to bring in a Computer Systems Validation (CSV) Engineer to join their team on site.

The role has strong possibilities for extension and requires applicants to be a minimum of C2 level German (written & spoken).

Responsibilities
  • Provide CQV MES technical support for multiple pharma manufacturing sites worldwide.
  • Keep systems and processes developed for computer and automation systems validation up to date and compliant.
  • Optimization of CQV support process, including developing standards and KPI reports.
  • Ensure standardization and efficiencies across multiple projects.
  • Compile and analyse validation data and make recommendations for changes and/or improvements.
  • Maintain all documentation pertaining to computer systems validation.
  • Participate on cross-functional project teams including development & deployment teams as well as customer Manufacturing, Engineering, Quality and other groups.
  • Working in a remote team environment (e.g. team members being in geographically dispersed locations).


Requirements
  • Minimum of a bachelor's degree with a minimum of 3+ years of related CSV industry experience (Pharma/Biotech).
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11.
  • Strong knowledge of computerized system development life cycle approach is required.
  • The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
  • Ability to work well as part of a team and independently.
  • Excellent PC skills with proficiency in either MES or automation systems.
  • Strong German and English written and verbal communication skills are required.


If you're interested in applying, please send over your CV today!
Start
07/2018
Dauer
12m
Von
Optimus Search GmbH
Eingestellt
21.06.2018
Projekt-ID:
1582519
Vertragsart
Freiberuflich
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