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Senior Continuous Improvement Engineer

Date:  Sep 22, 2022
Location: 

Maryland Heights, MO, United States

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

 

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

 

Summary of Position

The Senior Continuous Improvement Engineer executes the vision for translating Curium NA’s strategy and goals to efficient, sustainable and repeatable processes.  The position designs and implements engineering solutions for newly developed products, creating value by reducing execution time, cost and errors.

Essential Functions

  • Applies good engineering practices and analytical skills to identify, characterize and control process variability.  Uses structured tools (root cause analysis, FMEA, fault trees, etc) to identify and mitigate potential process failures related to newly developed products.
  • 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.
  • Designs, tests and implements process improvements to achieve reliability goals for newly developed products. 
  • Designs training for newly developed products and processes.  Delivers training to manufacturing technical teams and production operators.  Assists manufacturing technical teams with product support after new products are commercialized. 
  • Participates in root cause investigations of process deviations.  Designs and implements mitigation and containment solutions.
  • Utilizes technical writing strategies to create clear, concise and complete documentation supporting production operations (batch records, SOPs, specifications and training documents).  Prepares protocols, reports, change control and other regulatory documentation to support execution of reliability activities.
  • Creates preventative / predictive maintenance programs for new, critical equipment.  Assists development teams with equipment qualification and validation.

Requirements

  • Bachelor Degree in engineering or related scientific field required.  
  • Minimum of 5 years professional experience w/knowledge of pharmaceutical manufacturing and related compliance programs (FDA, NRC, EPA, OSHA) required.  
  • Knowledge of radiochemistry, aseptic processes, equipment procurement / construction / qualification preferred.
  • Demonstrated understanding of cGMP and related regulations.
  • Knowledge of reliability / continuous improvement methodologies:  Six Sigma, Lean, Root Cause Analysis, Failure Mode Analysis.
  • Excellent critical thinking and problem solving skills.  Demonstration of problem resolution in high stress / tight timeline situations.  
  • Strong business acumen, demonstrating the ability to translate technical process activities to business / financial results.
  • Knowledge of project management principles related to estimating, developing and managing schedules / resource plans. 
  • Proficiency in computer skills and experience with Microsoft Word, PowerPoint and Excel.
  • Strong time management, written and oral communication skills.   
  • Demonstrated ability to be effective as a collaborator in diverse teams.  
  • Agile approach and willingness to learn new things in a dynamic setting. 

 

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.
  • Standard office environment, coupled with approximately 50% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
  • Must be willing to wear a variety of personal protective equipment.  
  • Responsibilities also include the ability to lift up to 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.  
  • May be required to sit or stand for long periods of time while performing duties. 
  • Must be able to work outside of regular work hours, including weekends and overtime as needed.
  • Willingness to work in a team-based environment. 
  • Close attention to detail required. 

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 


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