Engineer II, Facilities

ElevateBio
United States
Workplace: OnsiteFull timeUSD 125,000 - 165,000Function: Facilities, Workplace & Physical OperationsExperience: 5+ yearsEducation: bachelorsSkills: ["Organized","Independent","Collaborative","Technical writing","Verbal communication"]

Support the operation, maintenance, and continuous improvement of GMP facilities, utilities, and infrastructure to enable safe, reliable, and compliant manufacturing. Troubleshoot equipment and utility systems with root-cause analysis, manage work orders and preventive actions, and support engineering projects through commissioning and validation. Own quality systems for change control, CAPAs, and deviations, lead walkdowns and commissioning tests, and collaborate across Facilities, Capital Projects, Validation, Automation, and Quality teams to optimize asset performance and regulatory readiness.

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ElevateBio
ElevateBio
1 day ago

Engineer II, Facilities

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Source: Company careers pageValidated by: Fursa AI
Last checked: 6 hours agoStatus: Live

Job Summary

Support the operation, maintenance, and continuous improvement of GMP facilities, utilities, and infrastructure to enable safe, reliable, and compliant manufacturing. Troubleshoot equipment and utility systems with root-cause analysis, manage work orders and preventive actions, and support engineering projects through commissioning and validation. Own quality systems for change control, CAPAs, and deviations, lead walkdowns and commissioning tests, and collaborate across Facilities, Capital Projects, Validation, Automation, and Quality teams to optimize asset performance and regulatory readiness.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Facilities, Workplace & Physical Operations
Seniority: Mid level

Key Responsibilities

  • •Ensure GMP facilities, utilities, and infrastructure operate safely, reliably, and compliantly through ongoing support and continuous improvement
  • •Troubleshoot equipment and utility systems, perform root cause analysis, manage work orders, and drive corrective/preventive actions
  • •Support commissioning and validation for GMP HVAC and base building utilities, including water, steam, gas, vacuum, and electrical systems
  • •Promote operational excellence across asset management lifecycle, maintenance and calibration programs, and CMMS support
  • •Lead walkdowns and commissioning testing for engineering drawings and infrastructure systems; manage change control, CAPAs, and deviations for facilities and utilities

Pay and Benefits

Salary: USD 125,000 - 165,000

Key Requirements

  • •BS degree in Mechanical, Chemical, Facilities, Industrial Engineering or equivalent
  • •5+ years’ experience in GMP biotech or FDA-regulated environment
  • •Hands-on troubleshooting with root cause analysis, work order management, and corrective/preventive actions
  • •Ability to organize work independently while collaborating cross-functionally
  • •Experience presenting and defending Facilities Engineering work in regulatory audits
Experience:5+ yearsGMP biotechFDA regulated environment
Education:Bachelor's
Skills:OrganizedIndependentCollaborativeTechnical writingVerbal communication
Languages:English
Tech Stack:GMPFDAHVACPressurizationAirflowTemperatureHumidityCompendial waterSteamGas systemsWater for injectionPure steamLiquid nitrogenClean compressed gas utilities (CO2, O2, N2)CAVacuumElectrical systemsUninterruptible power supplyStandby powerNormal power

Company Brief

ElevateBio
Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Cambridge, United States
Founded: 2017
WebsiteLinkedIn