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Automation CSV Support Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36425
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Automation CSV Support Engineer - North Carolina - 6 Months Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented Automation CSV Support 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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.
  • Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions.
  • Assist with the development of system requirements and specifications to ensure requirements are testable and meet 21 CFR Part 11.
  • Support generation of Kneat documents.
  • Review and approve Automation documentation including risk and impact assessments, computer systems validation plans, user requirements specifications, functional requirement specifications, trace-ability matrices, release reports, and all documents and deliverables within the scope of the Automation Master Validation Plan as needed.
  • 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 suiting the company's vision and objectives
  • Coordinate with various project work-streams including Automation, Automation System vendor(s), CSV, CQV, Utilities, Process Engineering, and others as needed.
  • Attend regularly scheduled project status meetings as needed.
  • Complete Safety, Project Procedure, and Project Instruction training as required.
Requirements:
  • Extensive direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
  • Extensive direct Computer System Validation experience working with Emerson DeltaV DCS
  • Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
  • Working knowledge of Kneat validation software is required
  • Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
  • Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
If you are interested, please apply now for immediate consideration and further information.

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