Project Engineer 2

Utility EngineerThe 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. Quick Summary (for hiring use)Focus: Utility system reliability, compliance, and performanceCore role: Technical SME + project engineer + operations supportEnvironment: GMP / biopharma manufacturingImpact: Ensures uninterrupted manufacturing and regulatory complianceExperienceTypically 3–8+ years in utilities or process engineering (GMP environment preferred)Core competencies Strong understanding ofUtility systems and infrastructureEngineering design principlesRegulatory requirements (FDA, EMA, cGMP)Knowledge of:Project lifecycle and validation processesInstrumentation and ISA standardsStrong troubleshooting, communication, and collaboration skillsUtilities SystemsBased on your Utilities Engineering scope:Water systems: WFI, WRO, clean water loopsSteam systems: clean steam generation/distributionGases and compressed airWastewater and chemical distribution systemsKey Responsibilities1. Technical & EngineeringIdentify, analyze, and design improvements for utility, facility, and process systemsProvide technical support for utility systems such as:Water pretreatment and distributionWFI (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 data.Troubleshoot 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 opportunities.Perform root cause analysis and drive corrective/preventative actionsContribute to the 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)The hourly rate for this position is between $58.00 -$60.57 per hour. Compensation: Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.