Bachelor's degree in Chemical or Mechanical Engineering
10+ years of significant engineering experience
Strong background in pharmaceutical/chemical process design
Proficient in capital project planning and execution
Demonstrated competency with financial systems and fiscal control
Familiar with commissioning and qualification activities
Knowledge of government regulations including FDA cGMPs and OSHA regulations
Responsibilities
Identify, plan, and conduct small- to medium-sized capital projects up to $5M
Work cross-functionally to set project scope, priorities, and schedules
Lead project teams using established management tools to stay within budget
Execute and direct design of processes, equipment, and facilities
Maintain project controls for cost, scope, and schedule, and develop execution strategy
Ensure compliance with policies and procedures, enhancing quality and effectiveness
Foster innovation and integrate approaches from multiple projects
Benefits
Opportunities for professional development
Collaborative work environment
Exposure to cutting-edge technologies
Engagement in impactful projects
Strong team-oriented culture
Full 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:
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).
