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IT Systems Analyst

  1. West Coast
Seattle
  1. Contract
Competitive
  1. CAPEX Projects
30-04-2024
34053
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IT Systems Engineer - Pharmaceuticals - Seattle - 12-Month Contract 

Are you looking for your next contract, and fancy the opportunity to work in the bustling Seattle? Our client, a global biotechnology organisation, are recruiting for a IT Systems Engineer to join their team in the construction of their new biopharmaceutical production plant. This new build facility will be vital vehicle in helping our client continue global access to life changing therapeutics.


Responsibilities:
  • Take over the responsibility as a System Owner for Manufacturing IT Applications and/or QC Analytics systems in a 24x7 Good Manufacturing Practice (GMP) environment.
  • Work with the Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
  • Perform system administration, support/troubleshooting, and lifecycle management activities for supported systems.
  • Work to identify opportunities to create additional value and improve business processes, compliance, and maximise the benefits of standardisation of technologies and leverage across sites.
  • Assist with system validation and lifecycle management processes.
  • Determine business criticality and product quality requirements, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.
  • Lead or coordinate technical discussions and vendor negotiations.
  • Support regulatory audits as needed.

Requirements:
  • Bachelor’s Degree in Information Technologies, Engineering, Sciences or equivalent experiences.
  • 3+ years of experience implementing and managing GxP computer systems in the manufacturing or laboratory domains.
  • Biopharmaceutical or similar Manufacturing domain.
  • Experience as a System Owner for validated GxP Systems.
  • Familiar with Data Integrity methodologies.
  • Experience writing Standard Operating Procedures (SOPs).
  • Basic understanding of Computer Systems Validation
  • Basic knowledge of Manufacturing Execution Systems, Distributed Control Systems (DeltaV), LIMS, Data Historian, ERP etc.
  • Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.

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


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