Process Engineer III/IV

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

Job Req code 424

Category: Engineering

About Us

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. 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 surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The Process Engineer III/IV role is part of the Process Engineering department, which supports all aspects of the manufacturing process from supply chain to shipment. The team assists in product design, development, manufacturing support, and are responsible for developing and testing solutions to solve a wide variety of technical problems.

The Process Engineer III/IV will serve as a senior engineer within the department and provide Subject Matter Expert (SME) expertise for the process optimization, process support and other engineering tasks as required. The individual will provide technical expertise regarding implementation of changes (change control) for optimization and business continuity. Individual should be well versed in process data collection to analyze opportunities to improve efficiency/address legacy equipment issues and devise solutions to a wide variety of technical problems. Process Engineer III should have knowledge of large process equipment, parts washers, autoclaves, ovens, clean in place (CIP) equipment, packaging equipment, distribution solutions, etc. The engineer must have a demonstrated record of successful completion of improvements in regulated environment, e.g., change control, CAPAs, etc.

As a core team member, the Process Engineer III/IV will oversee/monitor the work of others, including contractors, and will mentor junior engineers. The position will use process knowledge to successfully plan, design, and implement process improvements in addition to other engineering responsibilities. The role will participate in projects to improve product yield increase capacity and/or reduce overall production cost, and will support all manufacturing systems, current and new. The successful candidate will be an independent self-starter who can work with minimal direction and who takes ownership of a job from concept through manufacturing/implementation. The successful candidate will be highly motivated and a creative individual.

Requirements

What You Need to Achieve It:

 

  • Bachelor’s Degree in Engineering Discipline (Chemical Engineering or biomedical engineering) with a minimum of 7 to 10 years’ relevant work experience
  • Experience working in a GMP environment/medical device industry.
  • Experience with large process equipment (autoclaves, glass washers, ovens, centrifuges, etc.)
  • Ability to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skills beneficial.
  • Ability to read, write and comprehend English.
  • Experience with validation methods (IQ/OQ/PQ)
  • Experience with quality systems (change control, CAPA’s, etc. )
  • Good computing skills including Microsoft office.
  • Work well with others and have communication and interpersonal skills.
  • Ability to solve practical problems both individually and in a team environment.
  • Work independently with minimal supervision.
  • Experience using AutoCAD and/or Solidworks
  • Experience in medical device design and application of test standards.
  • Experience working in a hands-on environment.
  • Knowledge of GMP, GAMP guidelines, IEEE specifications, ISA specifications, ASTM specifications and batch process control in the life science industry.

What sets us apart?

  • Competitive Pay
  • 401K – vested immediately with 100% match
  • Education Assistance Policy - $5,000 per year for all employees
  • Medical, Dental and Vision
  • Flexible Spending Account or Health Savings Account
  • Wellness Program
  • Three weeks of vacation, 4 floating holidays, sick days, and company holidays
  • 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, or any other characteristic protected by law.