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Curium Pharma · 3 weeks ago

Senior Principal Continuous Improvement Engineer

St Louis, MO

Full-time

Onsite

Senior Level, Lead/Staff

12+ years exp

Curium Pharma is focused on improving operational processes, and they are seeking a Senior Principal Continuous Improvement Engineer to enhance efficiency through Six Sigma and Lean methodologies. The role involves designing and implementing processes, leading improvement programs, and ensuring compliance with regulatory standards.

Pharmaceutical

Hiring Manager

Michael Gruen

Responsibilities

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)

Qualification

Six SigmaLeanProject ManagementData AnalysisProcess DesignRisk AssessmentChange ManagementCritical ThinkingProblem SolvingTeam Facilitation

Required

Bachelor Degree in engineering or related scientific field

Twelve or more years of relevant experience 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