Job Req code: 708
Organogenesis is a leader in regenerative medicine focused on empowering healing through the development, manufacturing and sale of products for the advanced wound care, and surgical and sports medicine markets. Our Canton, MA headquarters has an opening for a full time Plant Engineer. We offer a comprehensive 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 Plant Engineer reports to the Associate Director of Capital Projects and works a Monday-Friday schedule during regular business hours, with flexibility for early and or/after-hours and weekends as required, to support manufacturing related facilities and utilities. This is an exempt position per the Fair Labor Standards Act (FLSA).
The Plant Engineer will have responsibility for the engineering support of manufacturing clean rooms, shipping areas, PD labs, and QC laboratories as well as mechanical utility systems including HVAC, steam, high purity systems, compressed air and vacuum systems, 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 Plant Engineer also implements commissioning and startup activities and maintains Facilities related QSR documentation. The support of capital projects is required as well as providing input in the development and execution of the company wide program.
- Support 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.
- Trouble shoot control and operational issues of utility and equipment systems that support manufacturing and lab operations.
- Support Facilities team with repairs as necessary to meet manufacturing needs.
- Support PCO and ECR processes necessary to make approved facility modifications as needed to support manufacturing operations. This will include the commissioning phase as well as supporting validation activities.
- 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.
- Update and write equipment and utility systems SOPs and work plans.
- Work with Contractors and Engineering firms to ensure proper facilities changes are implemented that meet QSR requirements.
- Establishes and coordinates BMCS needs with the Facilities Engineering and Controls Manager and Project Managers for capital projects.
- Performs additional related duties as assigned.
Preferred Education and Experience:
- BS degree in Mechanical Engineering or equivalent, plus at least 5 years of relevant experience in a cGMP manufacturing facility; or, 8 years of directly related facilities engineering support experience in a Biotechnology, Medical Device or Pharmaceutical Company required.
- Understanding of mechanical utility systems including HVAC, steam, high purity systems, compressed air, vacuum, etc.
- Understanding of automated monitoring and control systems.
- Familiarity with AutoCAD drawings/development methods, P&IDs and riser diagrams.
- Proficiency with electrical schematics and reading P&IDs.
- High standard of commitment to customers and quality of work, to operate within the QSR environment.
- Strong interpersonal, communication and analytical skills; able to develop and deliver technical subject matter information to non-technical staff and management.
- Collaborative, and able to work across multiple functional areas to deliver engineering and project requirements.
- Must possess the ability to handle many projects and priorities at the same time and keep track of important GMP documentation.
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