Elevatebio
Engineer II, Facilities
Waltham, Massachusetts, United States · Mid
Sponsorship not specified$25k-$50kDetected 15 days ago
AirflowComplianceCustomer SupportPLCControlsGMPFDA RegulatoryCommunicationPublic SpeakingWriting
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
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About the role
- Knowledge of HVAC systems, pressurization, airflow, temperature, and humidity performance.
- Knowledge of compendial water, steam, and gas systems.
- Promote operational excellence for asset management lifecycle, maintenance programs, and calibration programs for GMP facilities and utilities systems.
Responsibilities
- Ability to perform tasks in highly regulated industrial environment with adhere to safety and quality program policies.
- 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.
- 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.
Requirements
- BS Degree in Mechanical, Chemical, Facilities, Industrial Engineering or equivalent
- 5+ years' experience in GMP biotech or FDA regulated environment
- Experience presenting and defending Facilities Engineering in Regulatory Audits.
- 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.
- Hands on experience with troubleshooting equipment and utility issues with root cause analysis, work order management, corrective and preventive actions, and continuous improvement initiatives.
Compensation
- 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
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This listing is sourced directly from Elevatebio's careers page and normalized into a canonical job model.