System One Services Validation Engineer in Canton, Massachusetts
Validation EngineerCanton, MA
Category:Scientific & Clinical
Title:GMP Validation Engineer
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.
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.