Project Engineer II

About the role

The Project Engineer II leads capital projects supporting equipment installations, modifications, and process improvements in a GMP-regulated pharmaceutical manufacturing environment. This role involves managing projects from concept through startup, collaborating cross-functionally to deliver safe, compliant, and effective solutions.

Responsibilities

• 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

Requirements

• 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

• Service delivery
• Active collaboration
• Demonstrate agility
• Think differently
• Excellent execution

About Padagis

Padagis is a market-leading generic prescription pharmaceutical company specializing in extended topical medications. The company focuses on making prescription products more affordable for patients and reducing healthcare system costs. Padagis has a high growth trajectory with over 1,300 employees across six locations in the United States and Israel. The team values honesty and transparency, and offers opportunities for personal and professional growth.