0042V6277 Facilities Engineer - Project Engineer Consultant

Two River Consulting Partners•West Chester, OH

17d

About The Position

The Facilities / Project Engineer supports and leads facilities-related capital projects and engineering initiatives within a GMP-regulated manufacturing environment. This role is responsible for managing small- to mid-scale capital projects, supporting site utilities and systems, and ensuring compliance with regulatory and engineering standards. The engineer will act as a cross-functional leader, driving project execution, system reliability, continuous improvement, and audit readiness.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related discipline)
5+ years of experience in facilities, utilities, or project engineering within a GMP-regulated industry (pharmaceutical, biotech, or similar)
Experience managing capital projects and coordinating contractors/vendors
Strong knowledge of facilities systems (HVAC, utilities, clean utilities, etc.) and industrial automation/SCADA systems
Strong understanding of cGMP requirements, validation practices, and regulatory expectations
Experience with CMMS systems and engineering documentation management
Ability to lead investigations, perform root cause analysis, and implement effective solutions
Strong communication and leadership skills with the ability to work cross-functionally
Capable of working independently with minimal supervision in a fast-paced environment

Responsibilities

Provide facilities and utilities engineering support for aseptic fill/finish operations, with primary ownership of critical systems including WFI (Water for Injection), Clean Steam, HVAC (classified environments), and compressed gases
Support and optimize utility systems serving filling lines (vial, syringe, or cartridge), ensuring consistent performance to maintain sterility assurance and production uptime
Lead and execute small- to mid-scale capital projects related to fill line infrastructure and utilities, including equipment upgrades, expansions, and reliability improvements
Oversee commissioning, qualification (IQ/OQ/PQ), and ongoing lifecycle management of utilities and equipment supporting aseptic processing
Perform advanced troubleshooting of utility and facility systems impacting filling operations, driving timely root cause analysis and implementation of effective CAPAs
Own and manage GMP quality systems (change controls, deviations, CAPAs, impact assessments) specific to fill line utilities and facilities
Monitor and trend critical utility parameters (e.g., WFI quality, clean steam attributes, environmental conditions) to ensure compliance and proactively identify risks to product quality
Collaborate cross-functionally with Manufacturing, Quality, Validation, and Automation teams as an SME to maintain compliant, inspection-ready aseptic processing environments
Manage automation and controls initiatives for fill line and utility systems, including design, implementation, and lifecycle support of SCADA platforms; perform system integration assessments, gap analyses, and ensure alignment with site standards and data integrity requirements
Manage external vendors and cross-functional stakeholders through design, installation, commissioning, and validation activities; coordinate maintenance shutdowns, review and approve technical documentation (drawings, specifications, procedures), and provide on-call support while driving compliant, inspection-ready solutions