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CSV Engineer

  1. West Coast
Seattle
  1. Contract
Competitive
  1. CAPEX Projects
15-04-2024
33430
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CSV Engineer - Pharmaceuticals - Seattle - 12-Month Contract 

Our client, a global biotechnology organisation, is recruiting for a CQV Engineer to join their capital project in the Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CQV Engineer to help expand our client's biotech operations throughout the US. As the CQV Engineer you will be responsible for implementing all safety requirements for a new build facility.


Responsibilities:
  • Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
  • Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
  • Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
  • Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.

Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Familiarity with validation methodologies, including risk-based validation approaches.
  • Proficiency in creating and executing validation protocols and documenting validation activities.

If this role is of interest to you, please apply now! 

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