Engineer Staff I, Facilities
Ocular Therapeutix, Inc.
5 hours ago
On-site
Bedford, MA
Operations
Position Summary
- Engineer Staff I, Facilities responsible for design, operation, and maintenance of GMP and non-GMP HVAC equipment and systems supporting formulation, development, and commercialization at a GMP biopharmaceutical manufacturing plant. Works with Maintenance, Calibration, I&C, and Quality.
Responsibilities
- Oversee design/specification/selection of HVAC and Air Handling Units (AHUs) for GMP clean rooms, QC labs, warehouses, and general facilities (non-GMP, office, amenities).
- Oversee design/specification/selection of humidity control equipment for GMP clean rooms, labs, and warehouses.
- Ensure reliability and maintain HVAC, AHU, and humidity control equipment.
- Develop preventative maintenance plans, SOPs, and corrective maintenance practices.
- Provide 24/7 operation for ISO7 and less clean rooms, QC labs, warehouse areas, and non-GMP office spaces.
- Define HVAC/AHU/humidity mechanical and electrical design requirements, specifications, and procedures.
- Integrate/manage HVAC equipment with Building Automation Systems (BAS) and work with I&C on integration with BAS and Continuous Monitoring Systems (CMS).
- Support Validation on equipment calibrations; partner with QA on equipment lifecycle management.
- Lead HVAC/AHU/humidity scope on EPCCV capital projects.
- Develop onsite spare parts program and evolve/maintain Blue Mountain CMMS and job plans for HVAC PM effectiveness.
- Support GMP change controls, deviations, and investigations for HVAC/facility/utility/manufacturing systems.
- Identify energy-efficiency opportunities without compromising GMP compliance.
- Represent Facilities Group on regulatory audits related to GMP HVAC design, operation, and maintenance.
Qualifications
- BS required; preferably Mechanical, Chemical, or Electrical Engineering.
- Minimum 10 years’ HVAC experience in biotechnology.
- Knowledge of FDA/EU clean room classifications; ISO7 and Grade C.
- Experience with GxP manufacturing/utility/facility equipment design, implementation, maintenance, and reliability.
- Leadership in projects and sustaining operations.
- Proficient in MS Office.
- Experience with CMMS; BAS/BMS.
- Calibration and maintenance planning experience.
- Ability to collaborate and influence without direct authority.
- Knowledge of OSHA requirements; understanding of cGMP/GDP/FDA as applied to biopharmaceutical manufacturing.
Working Conditions
- Hands-on maintenance/troubleshooting; work with instrumentation plus electrical and mechanical equipment; lift up to 30 lbs.
- Work in cleanroom and chemical laboratory; handle chemicals.
- Willingness to support HVAC operations 24/7.
Salary Range
- $107,000–$123,000 USD.
- Engineer Staff I, Facilities responsible for design, operation, and maintenance of GMP and non-GMP HVAC equipment and systems supporting formulation, development, and commercialization at a GMP biopharmaceutical manufacturing plant. Works with Maintenance, Calibration, I&C, and Quality.
Responsibilities
- Oversee design/specification/selection of HVAC and Air Handling Units (AHUs) for GMP clean rooms, QC labs, warehouses, and general facilities (non-GMP, office, amenities).
- Oversee design/specification/selection of humidity control equipment for GMP clean rooms, labs, and warehouses.
- Ensure reliability and maintain HVAC, AHU, and humidity control equipment.
- Develop preventative maintenance plans, SOPs, and corrective maintenance practices.
- Provide 24/7 operation for ISO7 and less clean rooms, QC labs, warehouse areas, and non-GMP office spaces.
- Define HVAC/AHU/humidity mechanical and electrical design requirements, specifications, and procedures.
- Integrate/manage HVAC equipment with Building Automation Systems (BAS) and work with I&C on integration with BAS and Continuous Monitoring Systems (CMS).
- Support Validation on equipment calibrations; partner with QA on equipment lifecycle management.
- Lead HVAC/AHU/humidity scope on EPCCV capital projects.
- Develop onsite spare parts program and evolve/maintain Blue Mountain CMMS and job plans for HVAC PM effectiveness.
- Support GMP change controls, deviations, and investigations for HVAC/facility/utility/manufacturing systems.
- Identify energy-efficiency opportunities without compromising GMP compliance.
- Represent Facilities Group on regulatory audits related to GMP HVAC design, operation, and maintenance.
Qualifications
- BS required; preferably Mechanical, Chemical, or Electrical Engineering.
- Minimum 10 years’ HVAC experience in biotechnology.
- Knowledge of FDA/EU clean room classifications; ISO7 and Grade C.
- Experience with GxP manufacturing/utility/facility equipment design, implementation, maintenance, and reliability.
- Leadership in projects and sustaining operations.
- Proficient in MS Office.
- Experience with CMMS; BAS/BMS.
- Calibration and maintenance planning experience.
- Ability to collaborate and influence without direct authority.
- Knowledge of OSHA requirements; understanding of cGMP/GDP/FDA as applied to biopharmaceutical manufacturing.
Working Conditions
- Hands-on maintenance/troubleshooting; work with instrumentation plus electrical and mechanical equipment; lift up to 30 lbs.
- Work in cleanroom and chemical laboratory; handle chemicals.
- Willingness to support HVAC operations 24/7.
Salary Range
- $107,000–$123,000 USD.