Validation Engineer Senior #JN -062021-65156

West Greenwich, Rhode Island
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -062021-65156

Summary:

  • Can remain remote after Covid Policy is lifted
  • The role is responsible for ensuring Process Validation activities are performed in a consistent and controlled manner to support the manufacture of Drug Substance.

 Responsibilities include:

  • Lead Process Validation project activities at ARI
  • Support the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards
  • Lead the execution of validation projects and/or protocols and the collection of data to support completion of Process Validation activities
  • Review requirements and source process design and execution documentation for use in development of process validation documents
  • Develop/Update appropriate Validation Master Plans
  • Develop and author Validation protocols/reports
  • Author validation sections for Regulatory filings and/or provide data verification
  • Provide guidance for the generation, resolution and closure of deviations
  • Provide Process Validation oversight as part of the Change Control process.
  • Generate documents (Plans, protocols and reports)
  • Gather data for reports or provide data verification
  • Represent process validation in project meetings

 


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