Project Engineer II

The Project Engineer II is responsible for leading capital projects that support equipment installations, modifications, and process improvements in a GMP-regulated pharmaceutical manufacturing environment. This role manages projects from concept through startup, working cross-functionally to deliver safe, compliant, and effective solutions that support operational objectives.

Note: This position is a 100% on-site role at our Minneapolis location in New Hope, MN and pays between $75,000.00 and $95,000.00 USD based on experience. Additionally, this role is eligible for our annual incentive bonus and long-term incentive bonus plans and a robust employee benefits package.

• Lead capital projects from concept through commissioning, qualification, and operational handoff
• Define project scope, schedule, budget, and resource requirements with minimal supervision
• Manage vendors, contractors, and procurement activities to ensure successful project delivery
• Identify and mitigate project risks; drive issue resolution to maintain timelines and budget

• Lead design reviews and approve engineering deliverables to ensure compliance with process and operational requirements
• Oversee installation, commissioning, startup, and troubleshooting of manufacturing equipment
• Provide technical guidance on equipment modifications, process optimization, and system improvements

• Ensure all projects meet FDA, GMP, and Padagis quality system requirements
• Own change control activities, including initiation, impact assessment, and implementation strategy
• Lead validation and qualification efforts (IQ/OQ/PQ), ensuring readiness for regulatory inspection
• Ensure all documentation meets ALCOA+ data integrity standards

• Act as primary engineering representative on project teams, aligning Manufacturing, Quality, Validation, Maintenance, and EHS stakeholders
• Provide clear communication on project status, risks, and mitigation strategies
• Mentor junior engineers and provide guidance to technicians and operators during project execution

• Drive process improvements that enhance safety, quality, and efficiency
• Support site initiatives related to right-first-time execution and inspection readiness
• Identify opportunities for cost savings, capacity increases, and reliability improvements

• Develop and approve key project documents (URS, functional specs, protocols, reports)
• Track and report on project performance metrics (cost, schedule, scope)
• Lead project closeout, turnover, and lessons learned activities

• Bachelor’s degree in engineering (Chemical, Mechanical, Biomedical, Industrial, or related)
• 3-6 years of experience executing capital projects in manufacturing environments

• Experience working in pharmaceutical or other regulated manufacturing environments

• Service delivery – Understand who your internal and external customers are, identify their needs, and deliver value above their expectations
• Active collaboration – Seek opportunities to work together across teams, function, business units, and geographies to seek success
• Demonstrate agility – Proactively identify changes in our environment and act quickly, leading or embracing change
• Think differently – Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists
• Excellent execution – Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes