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Project Engineer II

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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.

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