Job Req code: 806
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.
Organogenesis corporate headquarters is located in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds). Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products.
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.
- Review BMCS and Validated CMS trends daily and investigate issues as they are presented.
- 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.
- Frequently is required to stand and talk or hear; and walk or sit.
- Regularly required to use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.
- Regularly lift and/or move tools, materials and equipment weighing up to 50 pounds and occasionally up to 100 pounds.
- Heavy Work - exerting 50 to 100 pounds of force occasionally, or 25 to 50 pounds of force frequently, or 10 to 20 pounds of force constantly to move objects.
A pre-employment physical and lift test will be required for this position once an offer has been accepted.
- Frequently around loud noises.
- Frequently works near moving mechanical parts.
- Frequently exposed to hot, cold, wet or humid conditions, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.
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