Project Engineer II We are seeking a Project Engineer II to lead and manage capital projectsranging from infrastructure to manufacturing and packaging equipmentwithin a cGMP pharmaceutical facility. This role is ideal for a proactive, detail-oriented engineer who thrives in a fast-paced, collaborative environment. Top Must-Have Technical Qualifications Capital Project Management : Proven experience managing capital projects over $1MM, including scope, budget, and schedule control. cGMP Environment Expertise : Minimum 5 years of engineering or project management experience in a cGMP pharmaceutical or regulated manufacturing environment. Engineering Tools & Documentation : Proficiency with project documentation such as URS, FMEA, FAT/SAT, CQV protocols, and change control processes. Software Proficiency : Strong skills in Microsoft Office Suite (Excel, Project, PowerPoint); AutoCAD experience preferred. Technical Knowledge of Manufacturing Systems : In-depth understanding of manufacturing and packaging equipment, utilities, and infrastructure systems. Budgeting & Procurement : Hands-on experience with capital budgeting, cash flow forecasting, and vendor/contractor management. Key Responsibilities Project Management Lead capital projects from planning to closeout, ensuring scope, budget, and timelines are met. Develop project scope, budget, milestones, and execution plans. Ensure compliance with cGMP, safety, and quality standards. Technical Execution Apply tools and methodologies such as: Design Phase: FMEA, URS, RFP, Vertical Start-Up Execution Phase: FAT, SAT, CQV, Decommissioning Closure Phase: After Action Reviews, Change Control, Handover Team Leadership & Communication Lead cross-functional teams including internal staff, vendors, and contractors. Maintain clear communication with stakeholders and provide regular progress updates. Foster a collaborative and accountable project environment. Financial & Operational Oversight Manage project budgets, cash flow, and procurement activities. Ensure timely and cost-effective project delivery. Maintain organized project documentation and reporting. Qualifications Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or Engineering Management preferred). Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Ability to adapt to changing priorities and schedules. What We Offer Opportunity to lead impactful, high-visibility projects. Collaborative and innovative work culture. Career growth in a mission-driven pharmaceutical organization. Industry : cGMP Pharmaceutical Manufacturing Schedule : Full-time | Flexibility Required (occasional weekends) How to Apply Ready to take the next step in your engineering career? Submit your application today and help us shape the future of pharmaceutical manufacturing.
Job ID: 481906405
Originally Posted on: 6/19/2025
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