The Facilities Project 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.
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.
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 a 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.