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Senior Process Engineer (Packaging Equipment Technology) : USA Application
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In this exciting and challenging opportunity, you will work as technical resource in support of current/ future, equipment/ process design and technology transfer, with specific emphasis on the filling and packaging portions of the process in a cGMP environment. Responsibilities include working with and/or leading teams to purchase, install, troubleshoot, optimize and maintain pharmaceutical grade equipment. This includes managing the change control process, writing and executing technical (Risk Assessments, Protocols, SOPs) documents and evaluating process deviation impacts. The incumbent provides process support to Operations, ensuring effective and efficient production of products.
- Provides technical expertise in packaging process development from bench-top through scale-up and commercialization, including equipment selection, purchase, installation, and validation.
- Evaluates new business opportunity
- Evaluates technology requirements for new business opportunities and recommends new technology or if existing technology can be modified
- Identifies and provides justification for critical process parameters with appropriate ranges to ensure robust, capable manufacturing processes.
- 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.
- Effectively communicates technical concepts in a way that non-technical personnel can understand.
- 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.
- Work history in pharmaceutical, medical device industry strongly preferred
- Hands on experience with packaging equipment, process and controls desired.
- 10 years of highly relevant, industry specific experience will be considered in lieu of degree.
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