Senior Validation Engineer

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. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission : to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.

The Senior Validation 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.

Key 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
• Prepares all protocols and reports for validation and revalidation work

Requirements

Preferred Education and Experience :

Other Skills / Abilities :

The anticipated annualized base salary is $95,000 - $116,000and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.

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.