Senior Project Engineer

Katalyst CRO; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a project leader to plan and execute capital projects for the API Pilot Plant and laboratories within the Synthetic Molecule CMC Research and Development organization. You will drive projects up to $5M, coordinating with multiple teams while ensuring alignment with regulatory expectations and business goals.

The role emphasizes delivering on time, within budget, and with compliant designs across process systems, equipment, and facilities, in a fast-paced, collaborative

Qualifications

• Bachelor's degree in Chemical Engineering or Mechanical Engineering with 10+ years of significant engineering experience.
• Strong technical background in pharmaceutical/chemical process system design including P&ID development, equipment specification, sizing and control systems.
• Experience planning and executing capital projects including scope development, cost estimating, budgeting, scheduling, and construction supervision.
• Has demonstrated competency with financial systems and fiscal control.
• Familiarity with commissioning and qualification activities including user requirement specifications and protocol development/execution.

Responsibilities

• Lead planning and execution of small- to medium-size capital projects up to $5M for the API Pilot Plant and laboratories.
• Identify, plan, and manage multiple concurrent projects; meet deadlines.
• Work cross-functionally to establish scope, priorities, and schedules; perform economic analyses and feasibility studies.
• Ensure design compliance with engineering standards and customer needs; conceptualize complete solutions.
• Maintain project controls for cost, scope, and schedule; develop execution strategy including procurement.

Skills

Project management

Budget management

Cross-functional leadership

Regulatory/compliance awareness

Strong communication

P&ID development

Process engineering knowledge

Education

Bachelor's degree in Chemical Engineering or Mechanical Engineering

Tools

Financial systems

P&ID software (e.g., AutoCAD/Autodesk)

Job description

Job Summary

• The primary function of this role is to lead the planning and execution of small to medium size capital projects supporting the API Pilot Plant and laboratories within the Synthetic Molecule CMC Research and Development organization of Client.
• The API Pilot Plant supports Client's pharmaceutical pipeline through process development and manufacturing of Active Pharmaceutical Ingredients (APIs) for pre-clinical toxicology studies, clinical trials, formulation development, and registration runs.

Roles & Responsibilities

• The primary function of this role is to lead the planning and execution of small to medium size capital projects supporting the API Pilot Plant and laboratories within the Synthetic Molecule CMC Research and Development organization of Client.
• The API Pilot Plant supports Client's pharmaceutical pipeline through process development and manufacturing of Active Pharmaceutical Ingredients (APIs) for pre-clinical toxicology studies, clinical trials, formulation development, and registration runs.
• Identifies, plans, and conducts small- to medium-size capital projects (up to $5M) related to the installation of new process/laboratory equipment and/or renovation of existing facilities. Manages multiple, often concurrent, projects and meets deadlines.
• Works cross-functionally to establish scope, priorities, and schedules on multiple projects. Independently performs economic analysis and feasibility studies related to complex and often multiple competing project alternatives. Responsible for achieving the project's financial targets in support of business objectives.
• Leads project teams in using established project management tools and techniques to stay within authorized budget limits and achieve the overall project and organizational objectives.
• Independently executes, and/or directs others in the execution of the design of processes, equipment, systems, and facilities by applying Client engineering theories, concepts, and techniques across multiple engineering disciplines. Ensures the project design complies with all engineering standards, project objectives, and customer needs. Conceptualizes complete solutions.
• Maintains project controls and reporting for cost, scope and schedule; develops execution strategy including procurement; balances multiple demands within an assignment. Understands the business needs of the company when developing a project scope. Incorporates business foresight of emerging technological trends.
• Responsible for compliance with applicable policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies.
• Fosters an environment of innovation and exchange of ideas. Integrates experiences and approaches from multiple projects/disciplines to develop the best solution in the total business context.

Education & Experience

• Bachelor's degree in Chemical Engineering or Mechanical Engineering with a desired 10+ years of significant engineering experience.
• Strong technical background and working knowledge in pharmaceutical/chemical process system design including P&ID development, process equipment specification, sizing and selection, instrumentation and control systems.
• Experience in the planning and execution of capital projects including scope development, cost estimating, preparation of requests for capital expenditure, scheduling, cost control, and construction supervision.
• Has demonstrated competency with financial systems and fiscal control.
• Familiarity with commissioning and qualification activities including development of user requirement specifications and protocol development/execution.
• Working knowledge of government regulations including building and fire codes, FDA cGMPs, local and federal environmental regulations, and OSHA regulations.
• Strong interpersonal and communication skills with demonstrated ability to work within a team environment. Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Technical background in pharmaceutical, biologics, or similar industries (preferred).