Project Manager-Engineering - Middletown, Delaware, US

Overview

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In this role, you will lead capital and engineering projects from scope through turnover at the Middletown drug product facility. You will coordinate cross-functional execution across Manufacturing, Quality, Finance, Procurement, and external partners to deliver on capital investments. You’ll drive scope, schedule, budget, risk, and vendor management to meet site priorities and funding. This is a hands-on, individual-contributor role that shapes project delivery for client-driven and site-capability initiatives. You will operate in a fast-paced, start-up–like environment and influence critical project outcomes with disciplined leadership.

Responsibilities
• Lead initiation, scope, business-case, cost estimates, schedules, and execution plans for capital projects
• Develop project charters, scope packages, milestones, resource plans, risk registers, and decision logs
• Coordinate URS, design criteria, layouts, specs, bid packages, and procurement strategies with SMEs
• Ensure equipment, utilities, automation, CQV, EHS, tooling, spares, and related costs are forecasted
• Own baseline scope, schedule, budget, commitments, actuals, forecast-to-complete, and estimate-at-completion
• Partner with Finance/Procurement to manage WBS, funding structures, PR/POs, cash flow, and financial closeout
• Lead cross-functional execution through design reviews, vendor selection, FAT/SAT, commissioning, qualification, turnover
• Manage OEMs, A/E firms, contractors, integrators, and service providers to scope, schedule, quality, safety, and docs
• Coordinate interfaces among equipment, facilities, automation, containment, packaging, and site infrastructure
• Resolve technical issues, design changes, field conflicts, punch lists, and vendor actions
• Ensure alignment with cGMP, Quality, EHS, permitting, and change-control requirements
• Coordinate CQV/Quality to support efficient qualification; ensure handover includes drawings, manuals, training, spare parts, and asset data
• Support closeout, lessons learned, financial settlement, and transition to Technical Services and Manufacturing
• Serve as primary project coordination point; maintain integrated schedules and proactive risk management
• Communicate issues transparently and balance schedule, cost, risk, GMP, and operational readiness
• Support site capital planning and visibility of current/future capital needs

Key requirements
• Bachelor's degree in Engineering or related technical discipline
• 7+ years of relevant engineering or xklufbp pharmaceutical manufacturing experience with project leadership
• Experience managing capital projects through all lifecycle phases
• Proven ability to manage scope, schedule, budget, risks, change control, vendors, and stakeholders
• Working knowledge of pharmaceutical cGMP and cross-functional interfaces across Engineering, CQV, Quality, Manufacturing, Automation, Facilities, EHS, Finance, Procurement
• Strong skills in project scheduling, cost tracking/forecasting, technical documentation, contract/vendor coordination, and executive communication
• Ability to manage multiple priorities in a fast-paced start-up/operational environment
• Strong communication
• Cross-functional collaboration
• Problem-solving under pressure
• Project scheduling
• Cost tracking/forecasting
• Vendor coordination