About this role
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…
About us:
At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products.
It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.
What's Next:
At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.