Senior Project Engineer

Stark Pharma Solutions Inc

  • Chicago, IL
  • 3 days ago

    Highlights

    The Senior Project Engineer will lead the planning and execution of small to medium capital projects supporting an API Pilot Plant and laboratory operations within a pharmaceutical R&D environment. The role will manage multiple projects, coordinate cross-functional teams, and ensure projects are delivered within defined scope, cost, schedule, quality, and engineering requirements.

    Numbers & Facts

    LocationChicago, IL

    Description

    Position: Senior Project Engineer
    Location: Illinois
    Duration: Long-Term

    Job Overview

    The Senior Project Engineer will lead the planning and execution of small to medium capital projects supporting an API Pilot Plant and laboratory operations within a pharmaceutical R&D environment. The role will manage multiple projects, coordinate cross-functional teams, and ensure projects are delivered within defined scope, cost, schedule, quality, and engineering requirements.

    Key Responsibilities

    • Lead planning and execution of small to medium capital projects up to $5M.
    • Develop project scope, schedules, cost estimates, and capital expenditure requests.
    • Manage project cost, schedule, scope, quality, and overall project controls.
    • Develop and review P&IDs, equipment specifications, and process system designs.
    • Support equipment sizing, selection, instrumentation, and process piping activities.
    • Coordinate with Engineering, Operations, Quality, R&D, and other cross-functional teams.
    • Conduct economic analysis, feasibility studies, and project planning activities.
    • Lead project teams and manage multiple concurrent projects.
    • Support construction, commissioning, qualification, and project startup activities.
    • Develop and support URS, commissioning documents, and qualification protocols.
    • Ensure projects comply with GMP, engineering standards, safety requirements, and applicable regulations.
    • Maintain project documentation, reporting, and financial controls.

    Required Qualifications

    • Bachelor's degree in Chemical or Mechanical Engineering.
    • 10+ years of significant engineering and project/process engineering experience preferred.
    • Strong experience in pharmaceutical, biopharmaceutical, or specialty chemical manufacturing environments.
    • Hands-on experience with process equipment such as tanks, reactors, pumps, piping, and instrumentation.
    • Strong knowledge of P&ID development and equipment specification development.
    • Experience managing capital projects, including scope, cost, scheduling, and quality.
    • Experience with capital expenditure planning, cost control, and construction supervision.
    • Familiarity with commissioning and qualification activities, including URS and protocol development/execution.
    • Working knowledge of FDA cGMP, OSHA, environmental, building, and fire code requirements.
    • Strong understanding of process system design and engineering standards.
    • Demonstrated financial and fiscal control experience.
    • Strong communication, leadership, problem-solving, and project management skills.
    • Ability to work independently and effectively in a collaborative, cross-functional environment.
    • Pharmaceutical or biologics industry experience is preferred.