Principal Engineer, Process Improvements
Company: PCI Services Limited
Posted on: November 9, 2018
This position is a key individual contributor role focusing on Quality, Process Improvements, and waste. The individual in this position will evaluate the current sampling plans for effectiveness, define improvements in the sampling methods and process controls, and execute the improvements. This position will collaborate with Quality, Engineering, and Operations to accomplish this goal. The expectation is to remediate all current validations, inspection plans, and process controls while implementing a strategy to create a documented process for project teams to use when launching new business. The documented process will become the global, standard solution for all of PCI. This individual must collaborate cross functionally and with all levels in the organization in order to deliver overall site goals, implement improved systems/processes/equipment, and develop site capabilities to support growth. This position reports to the Vice President, Engineering and will travel up to 50%. PRIMARY DUTIES: Statistically analyze all current and historical processes in order to determine optimum configuration and resourcing. Develop and present new and innovative options that will meet and/or exceed customer requirements while improving Quality, reducing waste, and enhancing efficiencies. Work with Operations, Engineering, and Business Development to assist customers in defining requirements while simultaneously helping to develop time-bound project plans to ensure timely execution. Monitor, track, and report key metrics such as Safety, Quality, Downtime, Throughput, and Spending in order to confirm that the projects of highest risk or biggest impact are being appropriately prioritized. Provide technical support to Operations as needed to minimize quality problems and improve process reliability. Develop and maintain standardized work, operational standards, and quality documentation related to quality and process enhancements. Collaborates with the Training Manager to develop and provide technical training for any new or improved process. Maintain and continuously improve the site/facility to meet all regulatory requirements, key customer needs, and support internal department requirements. Prepare monthly reports to management detailing the status of all open projects that support the quality, capacity, regulatory and process improvement requirements of the plant. Collaborate with Operations and the Planning Department to schedule and qualify project work. Utilize and promote Lean Six Sigma, Statistical Analysis, and Operational Excellence methodologies to deliver on all objectives, improve quality, and develop talent. Utilize data and the results of the statistical and process analysis in order to interact with customers and drive them all to an optimized and standardized process. The execution of all other duties assigned by Vice-President, Global Engineering. Requirements QUALIFICATIONS: BS Degree in a scientific or engineering discipline, advanced degree a plus A combination of Quality and Process Improvement experience that exceeds 10+ years CQE Certification Experience working with a pharmaceutical, biotech, or medical manufacturing environment Familiarity with foreign and domestic GMP regulatory and statutory requirements Proficient at performing statistical analyses and calculating process capability indices (i.e. CpK values, etc.) Equal Opportunity Employer/Vet/Disabled
Keywords: PCI Services Limited, Rockford , Principal Engineer, Process Improvements, Engineering , Rockford, Illinois
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