Responsibilities include:
- Evaluating and communicating new product/process feasibility
- Conducting process development and validation of new products
- Performing scale up processes from pilot to production
- Performing process FMEAs for new products
- Conducting plant trials/start up in support of process qualifications
- Developing validation scope documents for project planning and management
- Developing process qualification and validation protocols for technology transfer projects
- Conducting protocol training, executing process qualification and validation protocols, documenting and resolving deviations for technology transfer projects
- Writing reports and return field copy to QA validation with associated deviations completed
- Initiating, implementing and validating changes via change control processes
- Qualifying new alternate materials and components in products and processes
- Defining requirements, critical characteristics and specifications for new technologies, materials, components and processes
- - Initiating travel both domestically and internationally in order to ensure job objectives are met
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