CSV Specialist

1 week ago

Wilmington, United States Compunnel Inc. Full time

The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems. This role will primarily support the Newark manufacturing facility but may require some travel to other North American sites as needed.


Required Skills:

  • Bachelor’s degree required, preferred in computer science, engineering, or other sciences.
  • Minimum of 2-3 years of experience working with automation and/or computerized system validations.
  • Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.
  • Strong written and oral communication skills.
  • Strong organizational and time management skills.
  • Experience working in a GXP environment.


Responsibilities:

  • Support Data Integrity Manager with validation of automated equipment and control systems.
  • Responsible for execution of test scripts, creating, and modifying draft protocols
  • Responsible for reviewing previously executed CSV activities, identify gaps, including GMP documentation revisions
  • Support with creating and modifying validation documentation
  • Write reports which summarize the results of the protocol executions.

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