Validation - CSV Support (Aibonito, PR)

Guaynabo , Puerto Rico
full-time

AI overview

Support the Computer System Validation (CSV) lifecycle by developing SDLC documents and conducting risk assessments for manufacturing equipment validation.

Provide support for the CSV lifecycle

This position will work with Computer System Validation (CSV), IQ, OQ, GAMP5 CSV and will be responsible for: 

  • Develop SDLC documents for Manufacturing Equipment including CSV executions and reports
  • Validation protects as required by client. 
  • The validation deliverables may include URS, FRA, DQ, pFMEA, Risk Assessments, Traceability Matrix, FAT, SAT, IOPQ, Media Fill, Cleaning Validation, Process Validation. 
  • Development of CSV System Impact and Risk Assessment as part of the requirements of combined Equipment and CSV Validation Plan.
  • Development of IOQ protocol and Summary Report 
  • Review and Tests script inclusion (CSV) to Installation and Operational Qualification.

 

BS Engineering, Sciences

3+ years of experience

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

Validation & Engineering Group is a service provider dedicated to delivering specialized solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. We focus on a range of essential services including laboratory support, compliance, engineering, and project management, ensuring our clients meet rigorous industry standards.

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