Staff Engineer Jobs in Bedford, MA

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™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

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.
• 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.

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.