Project Engineer II

Padagis LLC; Minneapolis (MN); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Annual incentive bonus

Long-term incentive bonus plans

Robust employee benefits package

Job summary

Padagis LLC is seeking a Project Engineer II for our Minneapolis location. This role involves leading capital projects to support equipment installations and process improvements in a GMP-regulated pharmaceutical manufacturing environment.

The ideal candidate will manage projects from concept through startup, ensuring compliance with FDA, GMP, and quality standards. A Bachelor's degree in engineering and 3-6 years of relevant experience are required.

Qualifications

• 3-6 years of experience executing capital projects in manufacturing environments.
• Experience in pharmaceutical or other regulated manufacturing environments is preferred.

Responsibilities

• Lead capital projects from concept through commissioning.
• Manage vendors and procurement activities.
• Ensure compliance with FDA, GMP, and quality standards.

Skills

Project management

Cross-functional teamwork

Attention to detail

Agile adaptation

Education

Bachelor’s degree in engineering

Job description

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

• 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