Job Description:
The Project Manager will lead complex capital equipment and manufacturing transformation projects from concept through production launch. This role is responsible for driving project execution across engineering, quality, operations, supply chain, sourcing, facilities, and external suppliers to ensure projects are delivered safely, on time, within budget, and in compliance with applicable quality and regulatory requirements.
The ideal candidate will have experience leading large-scale manufacturing equipment implementation projects, managing external vendors, coordinating validation activities, and influencing cross-functional teams in a highly regulated environment.
This position operates independently with minimal supervision and requires strong leadership, communication, and problem-solving skills. The role does not have direct reports but is expected to lead and influence multidisciplinary project teams.
Essential Duties and Responsibilities
Project Leadership & Execution
Lead multiple capital equipment and manufacturing projects through planning, execution, validation, and production launch.
Develop and manage project scope, schedule, budget, resource plans, and risk mitigation strategies.
Drive alignment across engineering, quality, operations, supply chain, facilities, sourcing, and leadership teams.
Monitor project performance and proactively identify, communicate, and resolve risks, issues, and resource constraints.
Evaluate and authorize project changes that impact scope, schedule, cost, or technical strategy.
Vendor & Contractor Management
Manage equipment suppliers, contractors, and external partners throughout project execution.
Lead equipment design reviews, technical discussions, and project status reviews.
Coordinate Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment installation, and commissioning activities.
Hold vendors accountable to contractual obligations, deliverables, schedules, and performance expectations.
Technical & Validation Coordination
Coordinate development of User Requirements Specifications (URS), risk assessments, and project deliverables.
Partner with technical SMEs to ensure equipment designs meet manufacturing, quality, and operational requirements.
Support validation planning and execution, including FAT, SAT, IQ/OQ/PQ, engineering studies, and process qualifications.
Facilitate change control activities and ensure project compliance with applicable procedures and regulatory requirements.
Financial & Strategic Planning
Develop and manage capital expenditure requests (CERs), project budgets, and financial justifications.
Track project spending, forecast capital requirements, and identify opportunities to improve project return on investment.
Support long-term manufacturing strategy initiatives, insourcing efforts, automation programs, and capacity expansion projects.
Minimum Qualifications
Bachelor\'s degree in Engineering, Manufacturing, Project Management, or related technical field.
Minimum 4%2B years of experience leading capital equipment, manufacturing, or engineering projects.
Experience managing cross-functional teams in a manufacturing environment.
Experience working with external equipment suppliers and contractors.
Strong project planning, risk management, and stakeholder management skills.
Excellent written and verbal communication skills.
Preferred Qualifications
Medical device, pharmaceutical, aerospace, or other regulated industry experience.
Experience with capital equipment implementation and automation projects.
Experience coordinating FAT, SAT, validation, and equipment qualification activities.
Knowledge of quality systems, change control, and validation methodologies.
Experience developing capital requests, business cases, and financial justifications.
PMP certification or equivalent project management training preferred.
Key Competencies
Project Leadership
Cross-Functional Influence
Strategic Thinking
Risk Management
Vendor Management
Financial Acumen
Communication & Executive Presence
Problem Solving & Decision Making
Manufacturing & Process Understanding