Project Engineer II
Padagis LLC•Golden Valley, MN
•$75,000 - $95,000•Onsite
About The Position
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.
Requirements
- Bachelor’s degree in engineering (Chemical, Mechanical, Biomedical, Industrial, or related)
- 3-6 years of experience executing capital projects in manufacturing environments
Nice To Haves
- Experience working in pharmaceutical or other regulated manufacturing environments
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
Benefits
- annual incentive bonus
- long-term incentive bonus plans
- robust employee benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
