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.
Job duties:Project Leadership & Execution- 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
Technical Ownership- 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
Quality & Compliance Leadership- 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
Cross-Functional Leadership- 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
Continuous Improvement & Operational Excellence- 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
Documentation & Performance Management- 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
Required qualifications:- Bachelor's degree in engineering (Chemical, Mechanical, Biomedical, Industrial, or related)
- 3-6 years of experience executing capital projects in manufacturing environments
Preferred qualifications:- Experience working in pharmaceutical or other regulated manufacturing environments
Core competencies:Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five "core" competencies. We strive to bring employees on board the journey with us who exemplify these key competencies:
- 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...
