Validation Engineer I/II

85 Dan Road, Canton, Massachusetts, 02021, United States

Job Req code 307

Category: Quality

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space 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. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions.  Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The Validation Engineer I/II will be designated to support validations for a CGMP facility. The engineer will be responsible for assisting with executing Installation, Operation, Performance Qualification, Requalification and Revalidation protocols for manufacturing equipment, clean rooms, utilities and systems using established validation templates, standards and procedures. The Engineer will write and execute protocols for assigned validations. The engineer will also assist in process and cleaning validations.


How You Will Achieve It:

  • Prepares protocols and reports for validation, requalification and revalidation work
  • Assists with coordination and execution of 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
  • Prepares, reviews and summarizes equipment history files to assess the validated state of equipment
  • Assist in process and cleaning validations as required.
  • Supports other Validation Engineer II/III in the execution of validation protocols.
  • Participate in the review of Standard Operating Procedures (SOPs) for system projects


What You Need to Achieve It:

  • Associates/Bachelors degree with 1-3 years of experience in validating GMP systems. 
  • The candidate must have previous validation experience in 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.
  • Candidate will be a highly motivated and creative individual with  hands-on validation skills working under minimal supervision. 
  • A solid level of competency with Kaye Validator programming and calibration of thermocouples, validation of test equipment, and technical writing skills are preferred.
  • Strong familiarity with Microsoft Office, Word, Excel, and PowerPoint is required.


What can we offer you?

  • 401k -- generous employer match with immediate vesting and financial planning resources
  • Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
  • Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
  • Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
  • Paid maternity leave and parental leave for all new parents
  • Adoption benefits
  • Education Assistance Policy - $5,000 per year for all employees
  • Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
  • Employee Assistance Program
  • Generous paid time off including vacation, floating holidays, sick days, and company holidays
  • Free parking including an electric charging station (Canton and La Jolla)
  • Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint


We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.