Pharma GMP 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

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