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June

Csv Engineer (Delta V)

Quanta - Australia,

Any Industry
Source: uWorkin

JOB DESCRIPTION

Would you relish the opportunity to work with in one of the largest biopharmaceutical projects in Europe? If yes, then this is the assignment for you!

Our biotech client headquartered in Switzerland is currently investing significantly to their manufacturing programme. This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. With over 2000 employees onsite, the site is easily reachable by two major airports and has excellent transport links throughout.

The client is currently seeking the expertise of a Computer System Validation Engineer (CSV) with Delta V experience.

Main tasks will include:

  • Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.
  • Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.
  • Management and co-ordination of validation activities with internal departments, external contractors and suppliers.
  • Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.
  • Primary point of contact for validation related issues arising during validation activities (including protocol execution).
  • Investigation of deviations / non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements.
  • Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
  • Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).

Ideal background:

  • CSV within Biotech facility
  • Automation Systems experience (Delta-V)
  • CGmp/CGAMP experience
  • Strong knowledge of deviation and OOS reporting

If this looks like a role for you, please get in touch.

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