Facilities/Project Engineer(Aseptic/GMP)

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.

Job 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

Job 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

Ability to be on-site, full-time, in West Chester, OH