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
- 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
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.
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Skills Required
- Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, or related)
- 3-6 years of experience executing capital projects in manufacturing environments
- Experience leading capital projects from concept through commissioning, qualification, and operational handoff
- Knowledge of FDA regulations, GMP, and quality systems
- Experience with validation and qualification (IQ/OQ/PQ) and ALCOA+ data integrity practices
- Ability to manage vendors, contractors, and procurement activities
- Developing and approving project documentation (URS, functional specifications, protocols, reports)
- Willingness/ability to work 100% on-site in New Hope, MN (Minneapolis area)
- Experience working in pharmaceutical or other regulated manufacturing environments
What We Do
At Padagis our focus is on health care products that improve people’s lives. We are experts on extended topical products and are strategically investing to expand our #1 position in the extended topical category in the United States. Our team members, numbering more than 1,300 work in a dynamic environment where opportunity is built on a foundation of honesty and transparency.
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