Facilities & Utilities Engineer
united pharmaDurham (NC)
About the role
JOB Description:
Seeking an experienced Facilities & Utilities Engineer to support a GMP facility-fit and equipment-integration project within a regulated biopharmaceutical manufacturing environment. The consultant will evaluate the existing manufacturing suite and utility infrastructure against the requirements of planned process equipment. Responsibilities include reviewing existing facility capabilities, evaluating electrical power, gases, waste, HVAC and other required utilities, identifying capacity or distribution gaps, recommending room and utility modifications, supporting implementation layouts, developing preliminary facility/utility URS documents, and contributing to project cost, schedule, and CQV planning. The engineer will collaborate closely with process engineering, equipment engineering, manufacturing, MSAT, validation, and facility SMEs.
Qualifications:
GMP Facilities: Strong facilities engineering experience within pharmaceutical, biologics, cell and gene therapy, or other regulated GMP manufacturing environments. Facility Utilities: Experience evaluating utility capacity, distribution, and equipment tie-in requirements. HVAC / Cleanrooms: Strong understanding of pharmaceutical cleanroom and controlled-environment requirements.
Equipment Utility Requirements:
Ability to interpret equipment specifications and determine required facility utility connections and infrastructure. Facility Gap Assessments: Experience assessing existing facilities and identifying modifications required for new process equipment or manufacturing operations. Room Modifications: Experience evaluating room configuration, accessibility, equipment placement, and facility modifications. URS Development: Experience developing or supporting URS documents for facility and utility modifications. CQV: Working knowledge of commissioning and qualification requirements for modified GMP facilities and utilities. Project Estimating: Ability to support preliminary scope, cost, schedule, and implementation estimates. Cross-Functional Communication: Ability to independently gather information and work with Process Engineering, Manufacturing, MSAT, Validation, Quality, and Facilities stakeholders.
Ideal Candidate Profile:
A senior pharmaceutical facilities/utilities engineer who has supported the installation of new process equipment into existing GMP manufacturing areas. The ideal candidate can walk an existing suite, understand the equipment requirements, evaluate available utilities and room infrastructure, identify gaps, and clearly define what must be modified before installation and qualification can proceed.
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