Process Validation Engineer

Designation: Engineer

Location: USA

Qualification: Bachelor's Degree


  • Editing and preparing new/revised Design History Files and Design Control Documents that are submitted for the design control process.
  • Write protocols, execute validations, understand regulations, and make decisions
  • Go into validation packages and strengthen them, rational, re-execution, process to process, site to site
  • Redlines and Incorporates Assembly Procedure word files as required
  • Creates and Updates device configuration control documents as necessary
  • Interacts with related departments as necessary to ensure that redlined changes are implemented accurately including ensuring required training
  • Establishes change orders and prepares for change authorization and documentation
  • Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, manufacturing
  • Provides electronic storage for records retention to create images of documents and records. Indexes and organizes records based on standardized cross-filing system which can be retrieved in a timely manner
  • Monitors record retention of all documents and coordinates records retrieval from electronic and physical storages as requested

Bachelors Degree in Biomedical Engineering, Pharmacists, Chemical engineering, or related field.

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