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CSV Automation Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36905
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CSV Automation Engineer - North Carolina, United States - 6 Months Contract

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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Support development of integration protocols critical alarms in the electronic logbook and site notification system
  • Development of Kneat documents for DeltaV, Wonderware and other automation systems including Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.
  • Ability to follow a prioritized schedule and complete assigned tasks and deliverables on time with minimal direction.
  • Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions.
  • Develop Automation documentation including risk and impact assessments, computer systems validation plans, user requirements specifications, functional requirement specifications, traceability 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.
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.
  • Ability to manage commitments while displaying an eagerness to learn and continuously improve.
If you are interested, please apply now for immediate consideration and further information.
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