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A truly unique and exciting opportunity to contribute in a process/ equipment engineering capacity for Blow-Fill-Seal (BFS) technology, supporting company objectives with respect to process design, technology transfer and project management.
You will work with and/or lead teams to identify, develop and execute projects to meet or exceed all company goals. This could include: developing user requirement specifications, performing risk assessments, executing development protocols to support manufacturing, packaging, and cleaning processes. The successful candidate will provide process support to Operations, ensuring effective and efficient production of products… particularly in the unit dose categories of Blow-Fill-Seal (BFS) and stick pack.
• Provides technical expertise in process development from bench-top through scale-up and commercialization.
• Develops manufacturing, packaging, and cleaning processes in support of product development, clinical supplies, process development/scale-up, and commercial operations.
• Manages complex, multidisciplinary projects including project spending and project scope changes to ensure that required deliverables are realized within approved spending limits.
• Develops detailed project plans, budgets and timelines using project management tools such as Microsoft Project, and coordinates and ensures timelines with other departments (QA/Validation, Engineering, Operations, external resources, etc.)
• Ensures that team members understand and are committed to their specific objectives and to the ultimate goal of the project(s).
• Identifies project roadblocks early in the process, and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution. Insures resolution of cross-functional issues within the project team. When no resolution can be reached, ensures that issues are promoted.
• Closely monitors the status and results of all activities carried out under the project plan(s).
• Keeps plans up-to-date and ensures discrepancies are being resolved.
• Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
• Provides technical leadership on project teams and task groups, ensuring scientifically valid outcomes.
• Ensures smooth and on time technology transfer to launch / commercial site.
• Jointly leads process validation activities.
• Effectively identifies critical process parameters with appropriate ranges to ensure robust, capable manufacturing processes.
• Close collaboration with internal and external customers to meet their needs including both project and site initiatives.
• Identifies and implements continuous improvement opportunities to eliminate waste and drive the business forward.
• Writes technical reports and presentation relevant to drug product continuous processing activities
• Prepares regulatory submission documents.
• A Bachelor’s degree (or above) in engineering/ life sciences with a minimum of 5 years relevant experience is expected.
• Project management background is critical (PMP certification preferred).
• Work history in pharmaceutical, medical device industry strongly preferred and hands on experience with unit dose (BFS) manufacturing highly desired.
• 10 years of highly relevant, industry specific experience will be considered in lieu of degree.
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