Demo

CSV Engineer

Intellectt Inc
Philadelphia, PA Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/20/2025

Job Title : CSV Engineer

Location : Philadelphia, PA

Duration : 06 Months

Shift Timings : 8am – 5pm

Job Description : Client description :

  • Premier CDMO partner for large pharmaceutical companies focusing on cell and gene therapies.

Technology environment the consultant will be working in :

  • MS products, Master Control
  • Consultants day to day responsibilities :

  • Reviewing and editing system URS with the end users / SME’s. Primarily the sterility Assurance and EM group.
  • Meeting with vendors and IT to confirm which project deliverables are owned by the vendor and those that are owned by the client.
  • Drafting documents and pushing forward for approval. These include :
  • Configuration specification documents
  • CSV IOPQ
  • Traceability matrix
  • Once the project enters the execution stage, this resource will be responsible for validation execution.
  • Will also be supporting the vendor during the onboarding of the equipment and software
  • Required Skills :

  • Previous experience supporting a CSV project in a commercial pharmaceutical environment
  • Previous experience with Master Control or similar eQMS
  • Prior experience supporting a project that followed an ISPE GAMP 5 framework.
  • Previous experience with onboarding or qualification of enterprise-based systems
  • For example : These projects are taking place in an SAPB1 environment.
  • Previous experience drafting the following documents :
  • Configuration specification documents
  • CSV IOPQ
  • Traceability matrix
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