Project Engineer II

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

Benefits offered by this job

Annual incentive bonus

Long-term incentive bonus

Job summary

Padagis LLC is seeking a Project Engineer II to lead capital projects that support equipment installations, modifications, and process improvements in a GMP-regulated pharmaceutical environment. This on-site role is based at our Minneapolis location in New Hope, MN with a salary of $75,000–$95,000 USD and eligibility for annual and long-term incentive programs.

The role requires a Bachelor's degree in engineering and 3–6 years of experience executing capital projects in manufacturing, plus

Qualifications

• Bachelor’s degreein engineering (Chemical, Mechanical, Biomedical, Industrial, or related)
• 3-6 years of experience executing capital projects in manufacturing environments
• Experience working in pharmaceutical or other regulated manufacturing environments (preferred)

Responsibilities

• 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

Skills

Project leadership

Cross-functional collaboration

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

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 degreein 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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