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CSV Automation Engineer

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
34627

This vacancy has now expired

CSV Automation Engineer - Pharmaceuticals - North Carolina - 6-Months 

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.


Main Responsibilities:
  • 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, 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
  • Coordinate with various project workstreams 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.
 

Experience and Skills:
  • 5+ years’ direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
  • 3+ years’ 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
  • Knowledge with Drug Substance Manufacturing (DSM) would be beneficial
  • MasterControl, ComplianceWire, TrackWise, and Veeva experience is a plus
 

Additional Details
  • This will be a Time & Materials quote.
  • This role is 40hrs/wk and is intended to be an onsite position. If onsite is not possible, the candidate can work remotely, but must be onsite in Holly Springs, NC for the first 1 month. Periodical trips to site in subsequent months may also be required.
  • The current project role is for 6 months, but may extend further into a role on our expansion project
  • Provide rate sheet applicable for the duration of this project.
  • FDBN requires 30-day notice prior to resource changes

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

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