Project Engineer 2

Project Engineer 2The Utility Engineer serves as a subject matter expert in plant utility systems (e.g., WFI, WRO, and clean steam) and supports manufacturing operations to ensure reliable, compliant, and efficient utility performance at the site.Key Responsibilities1. Technical & EngineeringIdentify, analyze, and design improvements for utility, facility, and process systemsProvide technical support for utility systems such as: Water pretreatment and distribution WFI (Water for Injection) Clean steam and process utilitiesEnsure systems meet regulatory and performance requirements (FDA, cGMP, codes)2. Operations SupportSupport manufacturing by ensuring an uninterrupted and compliant utility supplyPerform daily monitoring and analysis of system performance dataTroubleshoot system/process failures and emergent issues (including off-hours support)Support maintenance and operations teams with technical expertise3. Projects & Capital ExecutionLead or support engineering projects across full lifecycle: Initiation, design, construction, commissioning, and validationDevelop and review: Project scope, schedules, budgets, URS, RFQs, and contractor packagesManage construction activities, contractors, and project close-out4. Compliance & DocumentationDevelop and maintain engineering documentation: PFDs, P&IDs, specifications, design reviews, FAT/SAT/IQ protocolsSupport: Deviations, investigations, CAPAs, and audit readinessEnsure systems operate in compliance with GMP and regulatory requirements5. Continuous ImprovementIdentify and implement system performance improvements and optimization opportunitiesPerform root cause analysis and drive corrective/preventative actionsContribute to improvement of engineering standards, practices, and procedures6. Collaboration & SupportWork cross-functionally with: Manufacturing, Quality, Maintenance, and FacilitiesProvide technical guidance to utility operators and techniciansSupport Global Engineering on major projectsQualifications/EducationBachelor's degree in Engineering (Mechanical, Chemical, Electrical, or Industrial)ExperienceTypically 3–8+ years in utilities or process engineering (GMP environment preferred)Core CompetenciesStrong understanding of: Utility systems and infrastructure, Engineering design principles Regulatory requirements (FDA, EMA, cGMP)Knowledge of:Project lifecycle and validation processes Instrumentation and ISA standards Strong troubleshooting, communication, and collaboration skillsUtilities SystemsBased on your Utilities Engineering scope: Water systems: WFI, WRO, clean water loops Steam systems: clean steam generation/distribution Gases and compressed air Wastewater and chemical distribution systemsQuick Summary (for hiring use)Focus: Utility system reliability, compliance, and performance Core role: Technical SME + project engineer + operations support Environment: GMP/biopharma manufacturing Impact: Ensures uninterrupted manufacturing and regulatory compliance