Senior Validation Engineer

Canton, MA

Job Req code: 927

Category: Quality Systems

Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing

The Validation Engineer III will be designated to support validation activities at our location on 150 Dan Road, Canton, MA.  

The engineer will be responsible for developing test protocols, prepare equipment, document test results and maintain records for installation, operation, performance qualification and requalification/revalidation protocols for manufacturing equipment and systems using established validation standards and procedures. The engineer will also assist in process and cleaning validations.

Job Responsibilities:

  • Prepares all protocols and reports for validation and revalidation work
  • Coordinates and executes validation studies for equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, and cold rooms
  • Performs testing using standard concepts, practices and procedures of the cGMP process
  • Reviews and summarizes equipment history files to assess the validated state of equipment
  • Makes adjustments to equipment or processes that require improvement and/or repair
  • Performs a variety of validation tasks and projects outside classical validation tasks and apply diverse engineering development skills in a creative manner in order to increase operational efficiencies and product quality, and decrease costs as assigned by supervisor and/or designee
  • Assist in process and cleaning validation as required.
  • Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects

 Job Responsibilities:

  • Prepares all protocols and reports for validation and revalidation work

Requirements

The candidate must have previous validation experience in the Pharmaceutical/Medical Device industry, be familiar with aseptic processing and clean room operations, be able to work independently, possess strong organizational skills, and have good written and verbal communication skills.

Associates or bachelor’s degree with 2-5 years’ of experience validating cGMP systems. Candidate will be a highly motivated and creative individual with strong hands-on validation skills working under minimal supervision.  A high level of competency with Kaye Validator programming, validation of test equipment, and technical writing skills are preferred. This position reports to the QA Validation Manager.