Principal Continuous Improvement Engineer

Principal Continuous Improvement Engineer

The Principal Continuous Improvement Engineer executes the vision for translating Curium NA's strategy and goals to efficient, sustainable and repeatable processes using Six Sigma, Lean and advanced project management techniques. The position creates value by reducing execution time, cost and errors within the three key operational functions: Development, Manufacturing and Compliance.

Essential Functions:

• Designs and implements processes, systems and governance consistent with Curium's continuous improvement vision.
• Collaborates with Development, Manufacturing and Compliance teams to apply continuous improvement principles (Six Sigma, Lean, etc) to reduce execution time and improve first-time right performance.
• Leads ad-hoc expediting efforts, rapid action teams, root cause analysis efforts and Kaizen events to achieve continuous improvement goals.
• Functions as a supplemental project manager when projects get off-track or face significant barriers.
• Leverages cross-functional collaboration to achieve timely outcomes from these activities.
• Partners with Development, Manufacturing and Compliance teams to plan and execute improvement programs.
• Provides Lean, Six Sigma, data analysis and process design skills to support these programs.
• Leads data and statistical analysis efforts.
• Guides teams on leveraging data / statistical outcomes to improve decision making.
• Reduces execution time and shortens time to detect / resolve critical problems with advanced predictive statistical models and simulations.
• Shortens new product development time through the use of statistical design of experiments.
• Administers systems used to support the continuous improvement vision.
• Develops procedures, reports and training to facilitate leveraging these systems to efficiently achieve program goals.
• Develops and manages metrics for monitoring process and system performance.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements:

• Bachelor Degree in engineering or related scientific field.
• 8 -10 years of experience in the pharmaceutical industry required.
• Assignments in at least two of the following areas: new product development, technical transfer, manufacturing operations, supply chain operations and compliance (FDA, NRC, OSHA, EPA).
• Trained in Six Sigma and/or Lean; certification as a Six Sigma Black Belt preferred.
• At least 5 years of demonstrated improvement gains achieved through application of Six Sigma / Lean skills.
• Excellent critical thinking and problem solving skills.
• History of leading high profile problem resolution in high stress / tight timeline situations.
• Strong business acumen, demonstrating the ability to translate technical process activities to business / financial results.
• Demonstrated project management experience in estimating, developing and managing schedules / resource plans.
• Experience with project management systems and application to multi-stage drug development projects desired.
• Knowledge of drug manufacturing and related compliance programs (FDA, NRC, EPA, OSHA).
• Knowledge of radiochemistry, aseptic processes, equipment procurement / construction / qualification an added benefit.
• Demonstrated skills in leading improvement teams. Skills include team facilitation, process mapping, data collection and analysis, risk assessment, innovation and change implementation.
• Can create and deliver effective reports and presentations.
• Skilled in balancing technical and behavioral elements of improvement and change management programs.
• Works well under pressure; able to function with abstract knowledge and short deadlines.
• Capable of leading multiple simultaneous projects.

Working Conditions:

Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.