Facilities & Utilities Engineer

United Pharma; Durham (NC); On-site; USD 110,000 - 190,000; Full time

Job summary

United Pharma is seeking an experienced Facilities & Utilities Engineer to support a GMP manufacturing environment. The consultant will evaluate the existing manufacturing suite and utility infrastructure against planned equipment requirements, review facility capabilities, and identify capacity gaps.

You will collaborate with Process Engineering, Manufacturing, MSAT, Validation and Quality to develop URS documents, CQV planning, and cost/schedule estimates for modifications required before

Qualifications

• GMP facilities experience in pharma/biologics GMP environments.
• Experience evaluating utility capacity, distribution, and tie-ins.
• Strong HVAC/cleanroom knowledge for controlled environments.
• Ability to interpret equipment specs and determine utility connections.
• Experience assessing facilities and modifications for new equipment.
• Experience evaluating room configuration and accessibility.
• Experience developing or supporting URS for facility modifications.
• Knowledge of commissioning/qualification requirements (CQV).
• Ability to estimate scope, cost, and schedule.
• Strong cross-functional communication with Process Eng, Manufacturing, MSAT, QA and Facilities.

Responsibilities

• Review existing facility capabilities and utility infrastructure.
• Evaluate electrical power, gases, waste, HVAC and other utilities.
• Identify capacity gaps and propose room/utility modifications.
• Support implementation layouts and URS documents.
• Contribute to project cost, schedule and CQV planning.
• Collaborate with Process Engineering, Manufacturing, MSAT, Validation and Facilities SMEs.

Skills

GMP Facilities

Facility Utilities

HVAC / Cleanrooms

Equipment Utility Requirements

Facility Gap Assessments

Room Modifications

URS Development

CQV

Project Estimating

Cross-Functional Communication

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.