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For the degreed engineer with a passion for leading edge process equipment technology in the pharmaceutical industry, please read on…
Unither Pharmaceuticals is Europe’s leader in unit dose pharmaceutical manufacturing for such products as eye drops, saline solutions, and sterile unit-dose asthma drugs using Blow-Fill-Seal (BFS) technology. Unither is also a global entity, with its US headquarters located in Rochester, NY.
After an extensive training program (including time spent in Europe) you would be assigned to projects pertaining to unit dose processes and equipment including…
- Develop user requirement specifications.
- Perform risk assessments.
- Execute development protocols to support manufacturing, packaging, and cleaning processes.
- Provide process support to Operations, ensuring effective and efficient production of BFS product.
The Career Evolution
Over time, and with experience you will learn to…
- Provide technical expertise in process development from bench-top through scale-up and commercialization.
- Develop manufacturing, packaging, and cleaning processes in support of product development, clinical supplies, process development/scale-up, and commercial operations.
- Manage complex, multidisciplinary projects including project spending and project scope changes to ensure that required deliverables are realized within approved spending limits.
- Develop 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.)
- Ensure that team members understand and are committed to their specific objectives and to the ultimate goal of the project(s).
- Identify project roadblocks early in the process, and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution.
- Resolve cross-functional issues within the project team. When no resolution can be reached, escalate the issue.
- Prepare project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
- Provide technical leadership on project teams and task groups, ensuring scientifically valid outcomes.
- Effectively identify 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.
- Identify and implement continuous improvement opportunities to eliminate waste and drive the business forward.
- Write technical reports and presentation relevant to drug product continuous processing activities
- A Bachelor’s degree in Electrical, Mechanical, Chemical or Industrial Engineering with 0-2 years of experience is expected.
- Internship in a relevant role/ or industry is a plus.
- Willingness to travel and/or live outside the U.S. for periods of time is required.
- Bilingual in English/ French preferred.
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