- 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.
Ultimate Solutions Corp is an Equal Opportunity Employer