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 Manufacturing Equipment Engineer II will have responsibility for the engineering, planning, design, and construction of manufacturing clean rooms, shipping areas, pilot plant offices, and laboratories, to meet the requirements of Organogenesis and its customers. This position provides engineering support for the modifications to manufacturing and building facilities, utilities and automated monitoring/control systems. The Facilities Project Engineer also implements commissioning and startup activities and maintains facilities related QSR documentation. The administration and management of capital projects is required as well as providing input in the development and execution of the company wide program.
 

How You Will Achieve It:

• Assist in the management of the implementation of any changes to the buildings or utilities, especially those under QSR requirements.
• Develop procedures and systems to control these functions that meet governmental regulations through QSR requirements.
• Generate project cGMP documentation needs.  These documents include URS, FRS and submittals to support commissioning and validation processes.
• Assist in the investigation and/or implementation of corrective actions based on Facilities related problems or incidents.
• Develop and execute engineering test protocols to commission new or re-engineered utility equipment or systems.
• Provide technical support to the PCO and ECR teams. Maintain files for facility-related drawings.
• Review and approve validations executed by the Validation Department and support the validation process.
• Design and build functional office areas to meet expected growth. Manage the contracts, construction plan for all new facilities.
• Performs additional related duties as assigned.

Requirements

What You Need to Achieve It:

• BS degree in Engineering or equivalent plus at least 2 years of relevant experience in a cGMP manufacturing facility OR 6 years of directly related project management experience in
• Biotechnology, Medical Device or Pharmaceutical Company.
• Experience in commissioning of mechanical utility systems including HVAC, steam, high purity systems, compressed air, vacuum, and IOS certified clean room environments is desirable.
• Understanding of automated monitoring and control systems is desirable
• Position works heavily within the QSR environment and thus must have a high standard of commitment to customers and the quality of work.
• Must possess the ability to handle many projects and priorities at the same time and keep track of important GMP documentation.

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.

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