Validation Engineer III

333 Providence Highway, Norwood, Massachusetts, 02062, United States

Job Req code 305

Category: Validation

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 III will be designated to support validation activities at our offices in Canton, MA and may report to our facility in Norwood, MA on an as-needed basis.      

The Validation Engineer III will be responsible for overall support of validation activities and developing test protocols for the qualification of various types of cGMP equipment, processes and system, developed/approved protocols, and will utilize knowledge of industry standard in engineering, industrial science and quality/regulatory requirement to ensure compliance.


How you will Achieve It:

  • Prepares all protocols and reports for validation and revalidation work;
  • Coordinates and executes validation studies for lab and testing equipment;
  • Performs testing using standard concepts, practices and procedures of the cGMP processes;
  • Reviews and summarizes equipment history files to assess the validated state of equipment;
  • Adjusts 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;
  • Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects


What You Need to Achieve It:

  • Master’s degree in Industrial Management, Industrial Engineering, Validation Engineering or a closely related field of study (foreign degrees accepted) and 1 year of experience validating cGMP systems or a Bachelor’s degree in Industrial Management, Industrial Engineering, Validation Engineering or a closely related field of study (foreign equivalent degrees accepted) with 5 years of experience validating cGMP systems.
  • CSV experience a plus.


Physical Requirements:

  • Able to lift 25 lbs. 


Environmental Conditions

  • Requirements include following ISO Class 7 gowning procedures


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.