Department: Operations | Location: Victor, NY | Reports to: Manufacturing DirectorJob Summary: The Process Engineer will support all aspects of process development including packaging. They will have an integral role in supporting equipment commissioning and qualification, development of cGMP operating procedures, and supporting ongoing operational capabilities. This includes qualifications, testing, troubleshooting, and continuous improvement.Key Tasks & Responsibilities:Provides daily on-the-floor technical support working closely with Team Leaders, Supervisors, and Engineers.Coordinate packaging process changes and new packaging introductions into cleanrooms, controlled environments, and material handling/boxing/labeling support areas.Identifies and drives implementation of improvements to maximize throughput and capacity utilization working closely with Continuous Improvement team.Lead in the selection, installation, and validation of medical device packaging equipment utilizing project management tools, Risk Analysis/pFMEA, and Lean Manufacturing techniques.Participate in developing Preventive Maintenance (PM) procedures and executing PMs for cleanroom equipment and production equipment associated with packaging or production activities.Support Engineering Change Management by maintaining routers, Bills of Materials, work instructions, and process setup forms including deviation requests.Support equipment qualifications (IQ, OQ, PQ) on new and existing processes and packaging equipment.Ensure that project and process development documentation are compliant with requirements and objectives. Review design, change specifications, and plan against process requirements.Knowledge, Skills & Abilities:Working knowledge of ISO 11607, ASTM D6198 and ASTM D4169.Knowledge of ASTM and ISTA package test methods.Experience in Design for Manufacturing, FMEA, DOE, and Validations.Experience using 3D CAD Design Software.Problem solving and decision-making skills are necessary and ability to work independently and with a team.Frequently communicates with other departments who have inquiries about projects, packaging specifics and sterilization procedures. Must be able to exchange accurate information in these situations.Education & Experience:BS Degree packaging Science and experience in the medical device or pharmaceutical industry.Physical Demands & Work Environment:Frequently required to lift, carry, push and/or pull from 30-50 lbs.Ability to periodically climb and use color vision/depth perception.Sitting, standing and/or walking for up to eight hours per day.LSI SOLUTIONS is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic.Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran. Associated topics: delivery, foam, fold, gluer, pack, packaging, packaging banding, seal, styrofoam, wrap
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