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System One Services Validation Engineer in Canton, Massachusetts

Validation EngineerCanton, MA

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:184049

Date Posted:02/26/2021

Title:GMP Validation Engineer

Location:Canton, MA

Schedule:Monday-Friday, 8am-5pm

Type:Direct Hire

Start date:ASAP

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, dehydrogenation 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.

Requirements:

  • 3 years experience in the Pharma/Med Device industry

  • Minimum of 3+ yrs. validation experience validating cGMP systems

  • Experience with incubators, clean rooms, freezers, gas systems, WFI water and purified water)Strong hands-on validation experience

  • Someone with longevity on projects(i.e. developed from beginning and saw it through to final product)

  • Someone who has developed, performed and summarized the validation process NOT just "assisted" with it.

  • Experience with clean room operations and aseptic processing

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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