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Process Validation Consultants

Bloomington, IN 00000

Posted: 11/23/2022 Employment Type: Contract Job Category: Engineering Job Number: 509203 Is job remote?: No Country: United States

Job Description


Our client has a staff augmentation need for multiple Process  Validation Consultant for a 3-month, on-site engagement.  This resource is needed for on-site CQV support of various manufacturing and lab equipment.  The clients Process Validation team facilitates at-scale mixing and hold studies, qualifies new products, and maintains the media fill program.

Responsibilities include, but are not limited to: 
  • Coordinating multiple projects
  • Documenting activities via protocols and summary report templates to help establish new templates and policies as needed 
  • Reviewing facility changes and providing input on re-validation
  • Assessing risks involved in processing steps and related to equipment
  • Developing and/or reviewing validation requirements and design deliverables
  • Partnering with contract validation teams to support and monitor efforts
  • Monitoring validation strategies, ensuring  polices are followed, conducting validation studies in accordance with batch records/protocols, and identifying exceptions associated with validation protocol execution
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