Manufacturing Engineer in Minneapolis, MN

ion systems, regulatory, technology transfer, etc. staff members to ensure relevant input and support for projects assigned. br br Essential Duties and Responsibilities br br Manufacturing Systems br br Performs review of packaging equipment, materials and test methods in support of manufacturing. br Investigates manufacturing problems, reviews factors relevant to determination of solutions, and prepares proposals for resolution as requested. br Review existing and develop new standard operating procedures to assure compliance with GMPs, Customer qualifications, and adherence to regulatory qualifications. br Implement process flow diagrams, line layouts and training to facilitate process improvement utilizing methods such as Lean and 5S. br Supports the documentation and periodic review of product and equipment specifications for all products, and associated development of in-process testing andor inspections to assure achievement of required specifications. br Represents the Manufacturing Department on special projects to investigate, plan and implement improved systems, whether manual or automated. br Coordinates plans and responses relating to internal and external audits assuring follow-through. br Conducts manufacturing related investigations, writes investigation reports, recommends corrective actions, and assures execution of agreed upon corrective actions through documentation and training. Process Improvement Support br br Supports the plan and execution of process time studies. br Identifies methods for optimizing production processes, to improve quality, and to contain cost. br Supports implementation of approved improved processes through development or modification of associated documentation, through training of personnel, and interface with Customers. br Supports development of plans for software engineering and validation as needed. br br New Business Support for Manufacturing br br Develops specifications, evaluates and recommends equipment and materials associated with packaging and product manufacturing in order to meet Customer needs br Conducts IQOQPQ activities in coordination with the Validation department. br Prepare protocols, sampling plans and other relevant documentation qualifications in compliance with ISO qualifications. br Works in conjunction with other designated departments in the development of package test methods. br Assists in evaluation of new manufacturing business opportunities and in preparation of associated bid proposals as requested. br Participates in Team meetings to develop project plans for initiation of new technology transfers or for revision of existing product lines. br Consults with internal and external Teammates, as well as, other entities to assure identification of relevant issues, cost, and manufacturing qualifications. br Works with the Project Team to assure development of methods for addressing issues and qualifications. br Prepares communication of manufacturing plans to relevant parties using appropriate media and format. br Coordinates and assists with start-up of associated new manufacturing operations by working jointly with the Customer and other designated members of Manufacturing, Validation, Laboratory, Accounting, etc. br Develops associated procedures, assures collection of relevant drawings, Bills of Materials, inventory records, etc. Production Planning and Scheduling br br Works with Customers, Technology Transfer, and Manufacturing to ensure availability of production resources and staff planning as requested to support project timelines. br Supports maintenance of production related items such as, equipment and SOPs to assure production schedules are meet. br br Production Resource Planning br br Supports the operation and maintenance of production equipment ensuring coordination with Validation and Quality. br Supports the development and design of work flow patterns to ensure efficient and effective use of facility space. br Provides training to manufacturing personnel to assure efficient use of equipment, materials and space such that operational goals are achieved. br 2yrs background working with packaging equipment and materials for use in the medical device, pharmaceutical or food industry with a demonstrated understanding of and background in Burst, Peel, Bubble Leak, and Dye testing standards and methods br Background in validating test methods for burst, peel, and bubble leak. br Demonstrate understanding of Distribution and Accelerated Aging standards and methods. br Expertise to use statistical methods such as Cpk analysis. br Proven expertise to interface with internal and external individuals regarding factors relevant to manufacture of medical devices or pharmaceutical products. br Expertise to work well with employees within the manufacturing area and with all functional areas of the company. br Willing to work on variable schedule as unexpected events occur. br Expertise to work with computers, Microsoft office suite applications, Microsoft excel, and other related software. br Expertise to organize and communicate complex details. br Expertise to lift and exert force of up to 25 pounds. br Color vision with the expertise to accurately identify and distinguish colors. br Corrected vision to 2020. br br Join Biotest Laboratories, br a STERIS Corporation company in its vision to see the world free from br Infection and Contamination as a br br Packaging Engineer br br STERIS is a 1B, publicly traded NYSE organization of over 5000 employees and is dedicated to providing innovative infection prevention, decontamination, and health science technologies, products and services. STERIS Corporation is an equal opportunityaffirmative action employer. br br STERIS Corporation Biotest Laboratories, Inc. complies with all obligations with respect to on-line application systems under guidelines provided by the US Department of Labors Office of Federal Contract Compliance Programs. If you are a disabled person who requires reasonable accommodation to complete an on-line application, please contact Rebecca Hoppe by phone at [removed phone], for assistance. br brListing originally posted at http

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