Engineering Project Manager
On-site · Waunakee, Wisconsin, United States
Job Summary
Engineering Project Manager for SPL near Madison, WI, responsible for planning, administering, and completing cross-functional engineering projects related to API manufacturing processes, facility expansions, and equipment installations. Leads project scope development, design, budgeting, funding approvals, scheduling, construction completion, start-up commissioning, validation, and documentation. Develops process and facility design parameters, secures funding, manages contracts with consulting engineers and construction firms, oversees installation and validation activities, and ensures compliance with QA and regulatory requirements. Drives optimization of processing systems, equipment reliability, and energy and water efficiency through DOEs, CAPAs, and data-driven troubleshooting (5-Why, Ishikawa, FMEA, A3/DMAIC). Establishes and maintains GMP change control, URS/specs, redlines/as-builts, SOPs, and training; supports commissioning and qualification activities and cross-functional problem solving to improve yield and uptime.
Required Qualifications
- Bachelor’s degree in engineering
- 5+ years of experience in engineering/project management
- Experience in design, construction and management of facility expansions and equipment installations
- Ability to develop project scope, budgeting, scheduling, and documentation
- Experience leading cross-functional teams and contracts with consulting engineers and construction contractors
- Experience with process and facility validation, start-up commissioning, and QA/regulatory compliance
- Knowledge of DOE, CAPA, GMP/change control (IQ/OQ/PQ)
- Familiarity with CPPs/CQAs and process control strategies
- Strong problem-solving skills (5-Why, Ishikawa, FMEA, DMAIC)
- Excellent communication and leadership abilities
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