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curium jobs

Posted on 19th October 2018

Lead Quality Engineer – New Product Support

United States
Quality
Permanent
1218

About Curium:

Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC.  Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.

Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe.  In fact, we have over 6,000 customers in over 70 countries world-wide.

At Curium, every single dose counts in helping doctors and patients diagnose and treat disease.  That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”.  We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration.  Our North American headquarters is in Maryland Heights, MO.  Come grow with us!

Scope of Position: 

The Lead Quality Engineer will work in a dynamic organization in the Project Support Group (PSG) for North America.  This role has the responsibility for supporting and implementing projects related to Curium’s business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products.  This role will help support activities associated with BD&L, M&A, PMO, and CMO activities.  Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc.  The Lead Quality Engineer will be responsible for working in collaboration with R&D, project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects from concept evaluation through commercial product launch.

Essential Functions:

  • Support large cross-functional projects and project teams through Subject Matter Expert quality compliance guidance in process evaluation, design, and implementation of processes
  • Provide cGMP, Regulatory, and Validation guidance in evaluation of new products within existing or new manufacturing equipment and clean room manufacturing areas
  • Partner with R&D, Manufacturing, Quality, Engineering, and Maintenance to develop applicable SOP’s, Batch Records, and Training Documents.
  • Define requirements for and generate project validation plans
  • Estimate quality and validation project activities to provide accurate cost and schedule targets
  • Manage project quality assurance and validation activities and resources
  • Generate, execute , and manage protocols
  • Work collaboratively with Project Manager to quickly move projects from scoping to implementation
  • Partner with Quality Leadership to ensure good quality and cGMP practices and their implementation in new product launch
  • Provide input to forecast estimates for project related costs and general project task tracking for adherence to project milestone goals
  • Generate and maintain quality risk assessments, including Failure Mode and Effects Analysis (FMEA)
  • Provide support for and manage preparation of documentation for regulatory filings

Requirements:

  • Bachelor Degree required; in Engineering or Sciences preferred
  • Five to seven years’ experience in quality assurance or validation roles in pharmaceutical manufacturing required
  • Experience in pharmaceuticals desired – willing to consider other development areas such as medical device experience; aseptic manufacturing experience highly preferred
  • Verifiable working knowledge of cGMP regulations and guidelines in a manufacturing environment required, application of cGMPs in an aseptic environment preferred
  • Management experience required, this position will have up to six direct reports charged with overseeing manufacturing design, ensuring adherence to GMP, interfacing with Regulatory Affairs, developing methods, implementing instrumentation, calibrating and validating, etc.
  • This position serves as the final approver of documentation for submissions, current knowledge of regulations is required
  • Strong project management and organizational skills, including ability to work independently and as a team member
  • Knowledge of regulatory requirements, and validation activities needed for manufacturing parenteral products
  • Familiar with project management tools and best practices
  • Experience applying formal Root Cause Analysis and problem solving methodologies
  • Proven ability in setting priorities and organizing work to meet deadlines
  • Technical understanding of the pharmaceutical development process from concept to launch; experience with stage gate processes for ANDA submissions preferred
  • Proven experience within complex multi-discipline project teams in a highly regulated environment
  • Strong oral and written communication skills with proven ability to communicate effectively in high pressure environments
  • Ability to react to problems and lead the team to develop solutions while communicating effectively to project leadership and stakeholders
  • Ability to maintain collaboration in a results driven environment
  • Agile approach and willingness to learn new things – ability to work “on the fly” in a dynamic setting
  • Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
  • Travel may be required up to 10% of the time
  • Lean and/or Six Sigma certification preferred

Working Conditions:

  • Willingness to work in a 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 xxxx% time in radiopharmaceutical manufacturing and laboratory environments.
  • Must be willing to wear a variety of personal protective equipment.
  • Willingness to work in a team based environment.
  • Close attention to detail required.
  • 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.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
  • Must possess good hand-eye coordination.

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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