Mechanical Utilities Engineer jobs in United States
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Staftonic LLC ยท 6 hours ago

Mechanical Utilities Engineer

positionMaryland, United States
timeContract
remoteOnsite
senioritySenior Level, Lead/Staff
date8+ years exp

Staftonic LLC is seeking a Mechanical Utilities Engineer to provide technical leadership for cleanroom HVAC and mechanical utility systems. The role involves reviewing engineering designs, ensuring compliance with ISO standards, and collaborating with various teams to ensure readiness for production.

Information Technology & Services
Hiring Manager
Shaik Aleem
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Responsibilities

Provide technical leadership for cleanroom HVAC and mechanical utility systems
Review and approve engineering designs, drawings, and specifications from A&E firms
Ensure ISO 14644 cleanroom compliance, pressure cascades, and temperature/humidity control
Oversee design and performance of utilities, including:
Chilled water
Hot water
Steam and clean steam
Compressed air
Vacuum systems
Nitrogen and other inert gases
Support risk assessments, design reviews, and stage-gate governance
Provide input to commissioning and qualification strategies
Support FAT, SAT, TAB, IQ, and OQ activities
Ensure all systems meet GMP, GEP, ISPE, and safety (SHE/EHS) requirements
Collaborate with quality, validation, operations, and digital teams to ensure readiness for production

Qualification

HVAC designGMP complianceCleanroom systemsPressure differentialsCommissioning activitiesRisk assessmentEngineering reviewsCollaboration

Required

8+ years of experience in HVAC and mechanical utilities within GMP pharmaceutical, biotech, or sterile manufacturing facilities
Strong experience with cleanroom HVAC design and operation
Solid understanding of pressure differentials, air changes, and humidity control
Hands-on experience with utilities for pharma manufacturing
Experience working with engineering firms (A&E) and equipment OEMs
Strong knowledge of GMP, ISPE, GEP, and regulatory compliance
Experience supporting commissioning and qualification activities
Ability to work on-site in Maryland approximately 60% of the time

Company

Staftonic LLC

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At Staftonic, we believe in turning possibilities into realities.
location
Columbus, Ohio, US
people-size11-50 employees
web-link
https://staftonic.com/

Funding

Current Stage
Early Stage
Company data provided by crunchbase