CSV / Part 11 Consultant
OnStaff USA - Mahwah, NJ

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The client says URGENT - we need someone now!
  • This job entails the creation/completion of all necessary Computer System Validation (CSV) documentation associated with the implementation of new electronic Design History File (eDHF) Change Request, Change Notice, and Change Activity / Task process workflows within PTC's Windchill enterprise PLM solution for the client’s R&D team.
  • This includes the creation/completion of:
    • a Testing Strategy
    • Test Scripts
    • Deviation Log(s)
    • a Requirements Traceability Matrix (RTM)
    • a Testing Summary Report
    • a Validation Summary at the very least.
  • It also includes the creation/completion of other project documentation and/or deliverables as required as well.

Job Requirements:

  • Experience in creating CSV and IT Systems Change Request is REQUIRED.
  • A thorough understanding of CSV and PLM processes is REQUIRED.
  • Knowledge of the Systems Development Life Cycle (SDLC) is required.
  • 6+ years IT or equivalent experience is required.
  • 3+ years of R&D and/or QA business process experience is required..
  • Excellent written and verbal communication skills are required.
  • Strong communication and trusted relationship building skills are required.
  • An ability to ensure / maintain clear communication channels between business stakeholders and IT technical teams is required.
  • An ability to partner with business representatives at all levels to evaluate business processes, understand and identify needs, define and document requirements, and drive creative IT services and solutions to improve efficiency and effectiveness is preferred.
  • An ability to understand, evaluate, document, and recommend changes to complex business processes is preferred.
  • Experience with process mapping is preferred.
  • Experience working in a regulated environment is strongly preferred.
  • Knowledge of PLM / Windchill Configurations and/or Development is preferred.
  • An ability to set expectations, overcome obstacles, and drive toward desirable outcomes is required.
  • Current knowledge / use of Microsoft Office products and an ability to understand complex software systems is required.
  • Familiarity with 21 CFR Part 11 and cGMP is REQUIRED.
  • A Bachelor degree in Business Management, Communications, Information Technology, Computer Science, or other Engineering degree with mathematics background or equivalent work experience is strongly preferred
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