Engineer II, Facilities

ElevateBio•Waltham, MA

6h•$125,000 - $165,000

About The Position

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.

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.
Ability to stand, walk, bend and stretch for extended periods 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

Nice To Haves

Knowledge of HVAC systems, pressurization, airflow, temperature, and humidity performance.
Knowledge of compendial water, steam, and gas systems.
Familiar with automated control systems, programmable logic controller, human machine interfaces, and human factors.

Responsibilities

Perform tasks in a highly regulated industrial environment with adherence to safety and quality program policies.
Troubleshoot equipment and utility issues with root cause analysis, work order management, corrective and preventive actions, and continuous improvement initiatives.
Support the 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 utility 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 resolve 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 protocols 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, construction, startup installation, commissioning, validation, standard operating procedure development, maintenance plan development, and continuous improvement.
Lead technical writing for standard operating procedures, engineering turnover packages, and engineering specifications in accordance with Good Engineering Practices.
Manage quality events for change control, CAPAs, and deviations for facility and utility infrastructure.
Work collaboratively with Facilities, Metrology, Capital Projects, Validation, Automation, Quality Control, and Quality Assurance teams.