The Role

This role supports the operation, maintenance, and continuous improvement of GMP facilities, utilities, and infrastructure to ensure safe, reliable, and compliant manufacturing operations. Responsibilities include troubleshooting equipment and utility systems, supporting engineering projects through commissioning and validation, managing quality systems such as change controls and CAPAs, and collaborating cross-functionally to optimize asset performance, regulatory compliance, and operational excellence.

Here’s What You’ll Do

• Ability to perform tasks in highly regulated industrial environment with adhere to safety and quality program policies.
• Hands on experience with troubleshooting equipment and utility issues with root cause analysis, work order management, corrective and preventive actions, and continuous improvement initiatives.
• Knowledge of HVAC systems, pressurization, airflow, temperature, and humidity performance. Knowledge of compendial water, steam, and gas systems.
• Support engineering lifecycle process for GMP HVAC systems, supporting base building utilities (Steam, Chill Water, Hot Water, Cooling Tower), water for injection, pure steam, liquid nitrogen, clean compressed gas utilities (CO2, O2, N2, and CA), vacuum, electrical systems (uninterruptible power supply, standby power, normal power), Biokill waste processing and pH neutralization systems to support Cell Therapy and Viral Vector clinical manufacturing.
• Promote operational excellence for asset management lifecycle, maintenance programs, and calibration programs for GMP facilities and utilities systems. Support asset management lifecycle in the CMMS.
• Provide customer service support to Facilities and Engineering team to align with department objectives. Participate in safety programs to mitigate and resolved safety risks in lab and manufacturing environments.
• Support quality management and engineering change management lifecycle for commissioning, validation, and standard operating procedures.
• Lead walk down of engineering drawings, piping, and instrumentation diagrams, for electrical, mechanical, plumbing, building management system and architecture. Perform commissioning test protocol for base building infrastructure and utility systems.
• Support facility and utility shutdown planning and utility expansion planning. Support small capital projects and safety improvements project scopes for facility and utility systems.
• Support development of reliability and predictive maintenance objectives.
• Participate in project teams through all phases of engineering projects including design, constructions, startup installation, commissioning, validation, standard operating procedure development, maintenance plan development, and continuous improvement.
• Familiar with automated control systems, programmable logic controller, human machine interfaces, and human factors.
• Lead technical writing for standard operating procedures, engineering turnover package and engineering specifications in accordance with Good Engineering Practices.
• Manage quality events for change control, CAPAs, and deviation for facility and utility infrastructure.
• Work collaboratively with Facilities, Metrology, Capital Projects, Validation, Automation, Quality Control and Quality Assurance teams.

Requirements

• BS Degree in Mechanical, Chemical, Facilities, Industrial Engineering or equivalent
• 5+ years’ experience in GMP biotech or FDA regulated environment
• Organized, independent, and collaborative
• Strong interpersonal, technical writing, and verbal communication skills
• Experience presenting and defending Facilities Engineering in Regulatory Audits.

Physical and Environment Requirements:

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to lift 25-50 lbs
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $125,000 - $165,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.