HVAC Engineer, Facilities

About the role

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. The HVAC Engineer, Facilities will be an individual contributor 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 role collaborates with Maintenance, Calibration, I&C, and Quality functions.

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 (SOPs), and corrective maintenance practices and procedures.
• Responsible for 24/7 operation of HVAC, AHU, and humidity control equipment servicing ISO7 and less classification clean rooms, 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 to develop HVAC knowledge, maintenance, troubleshooting practices, and equipment operation.
• Work with facility calibration technicians for HVAC-related equipment instrument calibration tolerances, specifications, and practices.
• Collaborate with the 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 leadership on HVAC, AHU, and humidity control equipment and systems for all capital projects involving Engineering, Procurement, Construction, Commissioning, and Validation (EPCCV).
• Responsible for HVAC equipment reliability and development of an 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.
• 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.
• Identify opportunities to optimize HVAC operations for energy savings without compromising GMP compliance.
• Represent the Facility Group on all regulatory agency audits regarding GMP HVAC design, operation, and maintenance activities.

Requirements

• 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.
• Proven team collaboration experience and the ability to influence others without direct authority.
• Knowledge of OSHA requirements, 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 environments.
• Position requires handling chemicals.
• Position requires willingness to support Facility HVAC operations 24/7.

Pay

$107,000 USD - $123,000 USD