0042V6277 Facilities Engineer - Project Engineer Consultant
West Chester, OH
Contracted
Mid Level
0042V6277 Facilities Engineer/Project Engineer Consultant
Please contact Amanda Mazza, [email protected]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:
West Chester, OH
EMPLOYMENT
C2C or W2
Please contact Amanda Mazza, [email protected]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
- 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
West Chester, OH
EMPLOYMENT
C2C or W2
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