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Senior CSV Engineer

  1. NI & Ireland
  1. Contract
Competitive
23660CT
  1. Commisions, Qualification and Validation
Date Posted28 Oct 2019
Our Partner in Ireland develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.

Our client is looking for a Senior CSV Engineer to join the team on a contract basis. 

Role Functions
  • As the CSV senior engineer for the project you will manage subordinate CSV resources and provide clear direction for systems validation approach within the project
  • 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 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
  • Work closely with the QA-IT function and ensure their requirements are met in all deliverables
  • Align with the HPV program: leverage existing documents & expertise where feasible 
  • Approval 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
  • Work closely with suppliers / integrators to ensure compliance with company standards
  • Participate in, and support, relevant project meetings
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements

Please apply with us today for immediate consideration!

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