Senior Project Engineer

About the Role

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 involves managing multiple projects, coordinating cross-functional teams, and ensuring projects are delivered within defined scope, cost, schedule, quality, and engineering requirements.

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.

Requirements

• 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.