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CSV Automation Engineer

  1. East Coast
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
25-05-2023
30972
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CSV Automation Engineer – Pharmaceuticals - Contract – North Carolina

Our client, a global pharmaceutical manufacturing organization are looking for a talented CSV Automation Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

CSV Automation Engineer Responsibilities:
  • Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program.
  • Develop Project Plans for the qualification of a Building Management System (BMS) and PLC based equipment for Drug Product (DP) and Finished Goods Manufacturing (FGM) areas.
  • Develop Project Plans for the qualification of IT and Automation Systems such as PAS-X MES (Manufacturing Execution System), Aveva Wonderware SCADA, Siemens Simatic PLCs, and Allen-Bradley PLC controls.
  • Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
  • Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time
About you:
  • Bachelor’s degree in chemical engineering/ Computer Engineering/ Computer Science/ Biological Science (or equivalent)
  • 5+ years’ direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulation
  • Knowledge of Automation Control Systems, Manufacturing and IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
  • Working knowledge of Kneat validation software is a plus.
Are you a good fit for this CSV Automation Engineer position? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

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