Pfmea manufacturing engineer - as284 - (Zelienople, PA)

Duties and Responsibilities: * Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ). * Define and document equipment & process requirements. * Develop/improve and maintain specifications and procedures for manufacturing, test and inspection processes, tooling and equipment. * Develop and execute test protocols (eg, validation protocols), author test reports, technical memos, investigations and document changes in accordance with regulatory and corporate requirements. * Perform risk assessments * Perform root cause analysis. Develop and implement corrective actions. * Support existing manufacturing product line(s). * Responsible for the production line efficiency improvements (processes, layouts, fixtures/tooling, etc). Utilize Lean tools to eliminate waste, increase capacity, and drive cost out of the process. * Trouble-shoot processes, designs, equipment and quality systems. * Participate in product, design and/or technology transfers.