Engineer Staff I, Facilities

Position Summary:

The Engineer Staff I, Facilities will be responsible for the design, operation and maintenance of GMP and non-GMP Heating Ventilation and Air Conditioning (HVAC) equipment and systems in support of formulation, development and commercialization of innovative therapies at a GMP biopharmaceutical manufacturing plant. This is an individual contributor role within the Facilities Engineering team, working collaboratively with Maintenance, Calibration, I&C, and Quality functions.

Principal Duties and Responsibilities:

• Oversee the design, specification and selection of HVAC and Air Handling Units (AHU) for GMP manufacturing clean rooms, Quality Control (QC) labs, warehouses, as well as for general facilities, non-GMP, office and amenities.
• Oversee the design, specification and selection of humidity control equipment for GMP manufacturing clean rooms, labs, and warehouses.
• Responsible for reliability and maintenance of HVAC, AHU and Humidity control equipment.
• Improve and develop preventative maintenance plans, standard operating procedures (SOP’s) and corrective maintenance practices and procedures.
• Responsible for 24/7 operation of HVAC, AHU and Humidity control equipment servicing ISO7 and less classification clean room, as well as for QC Labs, warehouse areas and non-GMP office spaces.
• Provide HVAC, AHU and Humidity control equipment, mechanical and electrical design requirements, specifications and procedures.
• Responsible for integration and management of HVAC equipment with Building Automation Systems (BAS).
• Work with Facility maintenance mechanics in the development of HVAC knowledge, maintenance and troubleshooting practices and equipment operation.
• Work with Facility calibration technicians for HVAC related equipment instrument calibration tolerances, specifications, practices.
• Work with Facility instrumentation and control (I&C) function on design, operation and maintenance of HVAC equipment integration with Building Automation Systems (BAS) and Continuous Monitoring Systems (CMS).
• Collaborate with and support the Validation team on equipment calibrations.
• Partner with Quality Assurance team members on the management of the equipment life cycle.
• Provide lead on HVAC, AHU and Humidity control equipment and systems on all capital projects for Engineering, Procurement, Construction, Commissioning and Validation (EPCCV).
• Responsible for HVAC equipment reliability Development of onsite spare parts program.
• Evolve and maintain Blue Mountain CMMS (computer maintenance management system) for electronic scheduling and documentation of all planned and corrective maintenance HVAC equipment activities.
• Continuously improve and develop CMMS HVAC equipment job plans to enhance PM effectiveness.
• Responsible for development and improvement of CMMS HVAC equipment job
• Support GMP HVAC, AHU and Humidity control equipment change controls, deviations and investigations on all facility, utility and manufacturing equipment and systems related initiatives and events.
• With regard to energy efficiency and sustainability, you will identify opportunities to optimize HVAC operations for energy savings without compromising GMP compliance.
• Represent Facility Group on all regulatory agency audits on GMP HVAC design, operation and maintenance activities.

 Qualifications:

• Bachelor of Science is required, preferably in Mechanical Engineering, Chemical Engineering, or Electrical Engineering.
• Minimum of 10 years’ experience with HVAC and related equipment within the Biotechnology industry.
• Knowledge of FDA and EU clean room classifications and operations, specifically ISO7 and Grade C clean room environments.
• Experience in GxP manufacturing, utility and facility equipment design, implementation, maintenance and reliability.
• Leadership roles in support of projects and sustaining operations on HVAC equipment.
• Proficient in MS Office
• Experience with a Computerized Maintenance Management System (CMMS).
• Experience with Building Automation Systems (BAS) or Building Management Systems (BMS).
• Experience with calibration and maintenance planning and
• Proven team collaboration experience and the ability to influence others without direct authority.
• Knowledge of OSHA requirements is crucial, as is an understanding of cGMP, GDP, and FDA requirements as they apply to biotechnology product/device manufacturing and disposition.

 Working Conditions:

• Position requires hands on maintenance and troubleshooting.
• Position requires the ability to work with instrumentation, electrical and mechanical equipment and lift up to 30 lbs.
• Must be able to work in both cleanroom and chemical laboratory
• Position requires handling chemicals.
• Position requires willingness to support Facility HVAC operations 24/7.

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