Project Engineer II

Padagis; Minneapolis (MN); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Annual incentive bonus

Long-term incentive bonus plans

Robust employee benefits package

Job summary

Padagis in Minneapolis is seeking a Project Engineer II to lead capital projects in a GMP-regulated pharmaceutical environment. You will manage projects from inception to completion, ensuring compliance with operational and regulatory standards, while working cross-functionally.

The ideal candidate possesses a Bachelor's degree in engineering and 3-6 years of capital project experience. This full-time role offers competitive salary, annual bonuses, and a comprehensive employee benefits package.

Qualifications

• 3-6 years of experience executing capital projects in manufacturing environments.
• Experience in pharmaceutical or regulated environments preferred.

Responsibilities

• Lead projects from concept through commissioning.
• Define project scope, schedule, budget, and resource requirements.
• Manage vendors and ensure successful project delivery.
• Oversee installation, commissioning, and troubleshooting of equipment.
• Provide technical guidance on process and system improvements.

Skills

Capital project management

Vendor management

Risk identification and mitigation

FDA and GMP compliance

Process optimization

Education

Bachelor's degree in engineering

Job description

This role will lead capital projects that support equipment installations, modifications, and process improvements in a GMP‑regulated pharmaceutical manufacturing environment. The Project Engineer II manages projects from concept through startup, working cross‑functionally to deliver safe, compliant, and effective solutions that support operational objectives.

Location and Compensation: 100% on‑site role at Minneapolis location in New Hope, MN. Salary between $75,000 and $95,000 USD based on experience. Eligible for annual incentive bonus, long‑term incentive bonus plans, and a robust employee benefits package.

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.

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.

Equal Opportunity Employer

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