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CSV Engineer

  1. Midlands
  1. Contract
Competitive
23394
  1. Commisions, Qualification and Validation
Date Posted03 Sep 2019
A global biotech company requires a CSV Engineer to join a new project in central Ireland.

The CSV engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the site teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.  

Role Functions
  • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
  • Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
    • Requirements Specification
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
  • Approver of all AIT SDLC deliverables, ensuring compliance with standards
  • Provide FAT oversight and perform leveraging assessments,
  • Provide guidance and support to AIT team members tasked with delivery of SDLC documents
  • Provide input to the development of realistic project schedules and document trackers
Knowledge, Skills, Education & Location Requirements
  • Fluent in English, written and verbal.
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written).
  • Relevant Computer Science or Engineering degree or equivalent
If this is you please apply today.



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