Lean Biologix is a full-service consulting company focusing on project management, testing and process improvement for FDA regulated manufacturers. We collaborate with our clients' internal resources to manage and execute projects that have a lasting impact. We provide on-time delivery and focus not only on project completion but sustainability. We leverage technology and lean principles to deliver efficient and manageable solutions to our clients most pressing problems. We currently have an immediate opening for a goal oriented and enthusiastic Packaging Engineer. The ideal candidate will have a minimum of either a BS in Packaging Engineering or a BS in other engineering discipline with experience with packaging qualifications relevant to the Pharmaceutical or Medical device industries. Knowledge of ISTA/ASTM testing procedures and GMP requirements a plus. This position will work closely with various clients in an effort to support clinical and commercial programs as well as work with our affiliated manufacturers and testing partners to define and implement packaging solutions that are compliant with industry standards and regulations.The position will require not only technical skills but good interpersonal and communication skills. This position also requires a person that can work independently but can work well with others and collaborate as a team member. The position offers competitive compensation and benefits.Responsibilities:Develop packaging User Requirement Specification (URS) with internal stakeholdersDevelop testing strategies and associated documentationLead qualification activities for shipping systems in support of product packaging that requires temperature control throughout various supply chainsWork with vendors to optimize packaging solutions based on client requirementsCommunicate with internal stakeholders to monitor project timelines, status and packaging requirements are met in support of regulatory filingsCoordinate material procurement and testing oversightSupport the implementation and maintenance of packaging solutionsDevelop cold chain and packaging procedures ?Preferred Qualifications & Experience:BS degree in Packaging or other Engineering discipline1- 3 years experience relating to Packaging within the medical industryExperience relating to Good Documentation Practices / Good Manufacturing PracticesHands-on approach to problem solving, risk identification and resolutionExcellent Microsoft Office skills (Word, Excel, Project)Ability to work on multiple projects simultaneously / adjust workload based upon prioritiesEffective analytical skills with demonstrated success in problem solvingExcellent verbal and written communication, organizational, and interpersonal skills If interested, please contact us at ...@leanbiologix.com. Associated topics: baler, delivery, distribution, foam, fold, label, packaging, packaging banding, packing, straw sealing
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