Jobs: Principal Scientist- Ultimate Solution Corp. Arroyo, PR

Elvin Joel Estrada Garcia's picture

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Description

The selected Professional must have experience in Sterility Validation Process areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry. The Principal Scientist will lead the sterility assurance scientific effort. This position is the key contact for Injection Molding Center of Excellence and Product Transfer project manager(s) on progress against project goals and deadlines for sterility assurance scientific matters.  As needed, represents the scientific effort at Management meetings. Advises on cross functional/divisional teams on new and potential products in respects to scientific principles, including but not limited to sterilization, sterile packaging systems, disinfection technologies, material compatibility and cleaning processes. Demonstrates leadership skills, acts as a role model to the company; promotes good communications and team work with the scientific arena.

Responsibilities
  • May serve as a sterility assurance expert to other sites as required.
  • Provide key technical input in scientific projects and to foster information sharing and implementation strategies which influence/drive the site short term and long term objectives.
  • Take active lead in the improvement of existing scientific processes and procedures to ensure consistently high quality outputs.
  • Investigate the feasibility of applying a wide variety of scientific principles and concepts to potential products, and problems.
  • Provide interpretation of results, guidance and scientific support to the Management team as required.
  • Hands-on involvement to identify and empirically evaluate new technologies to advance rapid microbiological methods and develop data-driven scientific and regulatory approach for their implementation where appropriate.
  • Participate in the development of clean room design/expansion projects.
  • Active participation in the Injection Molding Center of Excellence & Product Transfer projects through scientific advice in topics such as sterilization, sterile packaging systems, disinfection technologies, material compatibility and cleaning processes.
  • Deployment of Sterility Assurance Roadmap.
  • Approver of changes regarding sterilization, sterile packaging systems, disinfection technologies, material compatibility and cleaning processes. Active participation in investigations related to these topics.
  • Research projects to produce effective solutions for sterilization validation alternatives.
  • Demonstrate command of the required technical skills, as well as, an understanding of the broader general business responsibilities for partner cross-functional areas
  • Organize and facilitate effective meetings. Identify and delegate action items, follow-up/track action items to resolution, update project plans & deliverables, and as required, identify issues and ultimately resolve issues off-line (to ensure effective meetings at all levels)
  • Able to effectively communicate technical activities (both verbally and in writing) to all levels within the company and externally when required.
  • Continuously fully comply with all quality regulatory standard requirements and company policies.
  • May manage and evaluate directly and/or indirectly the activities of exempt and non-exempt employees.
 
Education
Bachelor of Science Degree in Science, Biology, Microbiology, and Chemistry preferred
 

https://usolutionspr.catsone.com/careers/index.php?m=portal&a=apply&jobOrderID=7071294&portalID=9941

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