Associate Validation Engineer

Amneal
Any Location, NJ
Job Description
The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements.

Requirements

  • Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software.
  • Perform re-qualification of equipment, facility and utilities as required under supervision.
  • Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
  • Draft Standard Operating Procedure(SOP) for new operational equipment.
  • Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
  • Works with equipment vendors to collect equipment manual and other required documents.
  • Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.
  • Assist with engineering projects and performs other duties as assigned.

Benefits

  • Equal Opportunity Employer
  • Non-discrimination policy
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