Engineer, Continuous Improvement

·         Evaluates product quality through deviation trend analysis to ensure products and processes are consistently produced within their quality attributes.

·         Coordinates the investigation and follow up processes for assigned site using various analytical tools (FMEA analysis, Ishikawa diagrams, etc.)  in collaboration with the appropriate departments, outside suppliers, vendors, and contract manufacturers.

·         Prepares investigations and incidents reports and recommends corrective actions as necessary for all product and process issues, and ensures timely completion of all investigations and corrective actions,

·         Recommends disposition of all involved product to the Quality Unit

·         Collaborates within a work group and may include cross functional projects

·         Other duties as needed

·         Bachelor’s Degree in engineering, chemistry pharmaceutical sciences or related field preferred; Associate degree and at least 4+ years manufacturing experience in similar role required

·         Demonstrated strong analytical, interpersonal, and technical writing skills. Familiarity with cGMP, FDA regulations, including experience with investigations and/or developing and recommending process improvements.

·         Computer literacy with a working knowledge Microsoft Office (Excel, Word) and SAP experience. 

·         Demonstrated ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.

·         Knowledge of principles, concepts and practices in pharmaceutical sciences and manufacturing processes.