Posted on 15th March 2019
Principal Process Engineer – New Product Support
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 Principal Process Engineer will work in a dynamic organization in the New Product Initiatives (NPI) group 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 Principal Process 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.
- Support large cross-functional projects and project teams through process evaluation, design, and implementation of robust processes
- Technical evaluation of new products relative to current site processes; process design for new products within existing or new manufacturing equipment
- Experience as product start-up manager responsible for coordinating product launch activities preferred
- Work collaboratively with Project Manager to quickly move projects from scoping to implementation
- Provide Aseptic Manufacturing expertise and guidance of evaluation and design of new processes
- 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
- Bachelor’s degree in Chemical Engineering or related field
- Eight years or more of experience in cGMP manufacturing environments
- Significant experience in optimization of processes, including establishment of process KPI’s
- Experience in pharmaceuticals desired, experience with medical isotopes preferred
- Strong project management and organizational skills, including ability to work independently and as a team member
- Experience with radiation safety programs (preferred but not required)
- Knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products, including lyopyhilization preferred
- Knowledge of current industry practices and technologies
- 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
- 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; experience with Smartsheet preferred
- Travel may be required up to 25% of the time
- Lean and/or Six Sigma certification preferred
- 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.
- 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 also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
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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