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Senior CSV Validation Engineer

4 months ago


Portage, United States Comrise Full time

Senior CSV Engineer- ONSITE- Portage, MI - 6 months+ Contract

  • Computer System Validation with experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry
  • Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry
  • Direct experience within the following areas: Computer System Validation (CSV), Data Integrity, 21CFR Part 11, ERES, Enterprise Systems Qualification, Master Validation Plans, Standard Operating Procedure (SOP), Change Control, Data Analysis, Deviations, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM)