Senior Project Engineer

Stark Pharma Solutions Inc; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

Stark Pharma Solutions Inc in Illinois is seeking a Senior Project Engineer to lead planning and execution of capital projects for an API Pilot Plant and lab operations. You will manage multiple projects, coordinate cross-functional teams, and ensure delivery within scope, cost, schedule, and quality.

The role requires hands-on engineering design, cost control, and compliance with GMP, FDA cGMP, and safety standards, with strong leadership and communication skills to drive projects from

Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering.
• 10+ years of significant engineering and project/process engineering experience.
• 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.

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.

Skills

Project management

P&ID development

Process engineering

Cross-functional teamwork

Cost control

Quality assurance

Regulatory compliance

Independent work

Education

Bachelor's degree in Chemical or Mechanical Engineering

Job 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.