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Job Summary Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches.
Assigned projects will have a limited scope.
Assists in preparing the manufacturing site for the manufacture of new products.
Communicates as necessary with the various plant departments, other support departments, project team members, and other internal customers.
Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches.
Works with management to translate development findings into manufacturing processes.
Technically assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
Provides information and documentation needed for regulatory submissions or responses as required.
Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
Executes necessary investigative studies to address product deviations and changes to a manufacturing process.
Supports product life cycle through execution of continued process verification reports.
Supports cleaning validation/verification program by calculating limits, acting as study director for protocols, swab sampling, and evaluating products for cross contamination.
Assesses feasibility of simple research and design concepts related to modernizing a product/product family or enhancing knowledge of a product/product family which includes but not limited to compatibility studies for tubing, vials, and stoppers, thermal cycling studies, light studies, and studies which support product insert.
Consult with senior peers on non-complex projects to learn through experience.
Technical reviewer for tables and basic protocols and final reports.
Updates Standard Operating Procedures based on supporting validation.
Perform any other tasks/duties as assigned by management.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.