Validation Engineer III

Dedham, MA
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Type: Direct-Hire

Category: Engineering

Job ID: 140867

Date Posted: 05/16/2019


Validation Engineer 

Education:

  • BS in Engineering


Required Skills and Experience:

  • Minimum of 3+ years of validation experience in the Pharma/Med Device industry
  • Experience validating cGMP systems
  • Strong hands-on validation experience with incubators
  • Someone with longevity on projects(i.e. developed from beginning and saw it through to final product)
  • Some who has developed, performed and summarized the validation process 
  • Experience with clean room operations and aseptic processing

Primary Responsibilities:

  • Prepares all protocols and reports for validation and revalidation work
  • Performs testing using standard concepts, practices and procedures of the cGMP process
  • Reviews & summarizes equipment history files to assess the validated state of equipment
  • Participate in the creation and/or review of SOPs for system projects
  • Coordinates & executes validation studies for equipment including(autoclaves, depyrogenation ovens, glass washers & utility systems- clean steam, WFI water, purified water & gas systems)Responsible for developing test protocols, prepare equipment, document test results, maintain records for installation, qualification and performance qualification. 

Location: Dedham, MA 

Duration: Direct Hire


 


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