JVT Advisors

Computer Systems Validation Specialist

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Location: Marlborough, Massachusetts
Employment Type: Contract

Job Description

Contract Length:  up to 24 months

Job Summary:  Hands on position responsible for authoring test scripts and other CSV documents required for the validation of GAMP 5 Category 4 (configurable off the shelf) computer systems. Candidates should be familiar with COTS systems used for clinical development and quality activities in a pharmaceutical environment. Work with business users and Information Technology to ensure the systems remain in a validated state through appropriate change control procedures.

Responsibilities:

  • Hands on position responsible for validation of GAMP 5 Category 4 (configurable off the shelf) computer systems in a GxP environment.
  • Authors all validation deliverables including risk assessments, validation plans, user requirements, test plans, test scripts, traceability matrix, test summary reports, and validation summary reports.
  • Reviews executed test scripts. Provides input to the project manager for all validation activities and deliverables.
  • Reviews vendor provided documentation for suitability.
  • Participates in project team meetings with IT and Business.
  • Requires participation in early morning and/or evening teleconferences with global project teams.

Requirements:

  • Strong validation experience including the validation of global data repositories (warehouse / data lake) with analytics and collaboration tools in a GxP environment.
  • Good understanding of IT infrastructure terminology and concepts and a thorough understanding of electronic records and electronic signatures requirements (FDA, PIC/S, Annex 11).
  • Excellent oral and written communication skills.
  • Ability to manage multiple validation projects at one time; work independently and work with global business and IT members with limited validation experience.
  • Experience validating systems used to support clinical trials in a pharmaceutical environment (e.g. eTMF, CTMS, safety systems, clinical trial registration, statistical analysis, EDC) and GMP/QMS activities (e.g. labeling artwork management, serialization, document management, learning management) preferred.
  • Minimum of 2 - 3 years' experience writing CSV test scripts, protocols and summary reports.

 

 

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