Senior Project Engineer

Location: North Chicago, IL (100% Onsite)

Duration: 1–2 Year Contract (Based on Performance & Business Needs)

Seeking an experienced Senior Project Engineer to support capital projects within the API Pilot Plant and Synthetic Molecule CMC Research & Development organization. This role is responsible for leading the planning, design, and execution of small- to medium-sized capital projects involving pharmaceutical process equipment, laboratory systems, and facility improvements. The ideal candidate will have a strong background in pharmaceutical or specialty chemical manufacturing, process engineering, and capital project management.

• Lead the planning and execution of capital projects supporting API pilot plant operations and laboratory facilities.
• Manage multiple concurrent projects from concept through commissioning while maintaining project scope, schedule, budget, and quality.
• Develop project scopes, cost estimates, schedules, procurement strategies, and capital expenditure requests.
• Design and review process equipment and systems, including P&IDs, process equipment specifications, instrumentation, and utility systems.
• Coordinate with Engineering, Operations, Maintenance, Quality, Procurement, and external vendors to ensure successful project execution.
• Oversee equipment installation, construction activities, commissioning, and qualification efforts.
• Develop User Requirement Specifications (URS) and support commissioning and qualification protocol development and execution.
• Perform engineering feasibility studies, risk assessments, and technical evaluations to support project decisions.
• Ensure compliance with FDA cGMP, OSHA, environmental regulations, building codes, and company engineering standards.
• Track project progress, budgets, schedules, and performance while providing regular updates to stakeholders.
• Support continuous improvement initiatives and identify opportunities to enhance plant reliability, efficiency, and safety.

• Bachelor's degree in Chemical Engineering or Mechanical Engineering
  .
• 10+ years of project or process engineering experience within pharmaceutical, biotech, specialty chemical, or related manufacturing industries.
• Strong experience managing small- to mid-sized capital projects.
• Hands‑on experience with pharmaceutical process equipment including:
• Reactors
• Tanks
• Pumps
• Process piping
• Process instrumentation
• Utility systems
• Experience developing and reviewing:
• P&IDs
• Process equipment specifications
• Equipment sizing and selection
• Instrumentation and control systems
• Experience with project planning, scheduling, budgeting, procurement, and cost control.
• Familiarity with commissioning, qualification, and validation activities, including URS development and protocol execution.
• Strong understanding of FDA cGMP regulations, OSHA requirements, environmental regulations, and engineering standards.
• Excellent communication, leadership, and cross‑functional collaboration skills.

• Experience supporting API Pilot Plants or pharmaceutical manufacturing facilities.
• Background in Active Pharmaceutical Ingredient (API) process development or specialty chemical manufacturing.
• Experience with laboratory facility upgrades and process development environments.
• Familiarity with financial systems, capital expenditure management, and project reporting.
• Experience leading multidisciplinary engineering teams and managing external contractors/vendors.