{"id":1222288,"url":"https://alion.io/job/lupin-manufacturing-engineer-ii","title":"Manufacturing Engineer II","company":{"id":2071871,"name":"Lupin","domain":"lupin.com","url":"https://alion.io/company/lupin-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["United 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maintains manufacturing documents including engineering drawings, BOMs & Travelers, manufacturing process instructions, and engineering change orders\nCoordinating engineering and production builds, including drafting manufacturing process instructions\nCommunicate manufacturing capabilities, production schedules, or other information to facilitate production processes.\nAuthors and perform process development activities including but not limited to Process Development, Preventive Maintenance & Calibration Requirements, IQ / OQ / PQ.\nDemonstrates application of Design or Experiments, SPC, Process Capability, Gage R&R and MSA for the Manufacturing Process Controls.\nAuthors and utilize xFMEAs to identify and address potential manufacturing defects, and minimize risk to patient safety.\nAbility to solve complex technical problems with equipment and/or manufacturing processes using 5-why, Fishbone, Is-Is Not frameworks.\nAble to understand and operate semi-automatic, and automatic assembly equipment to assemble drug device combination products.\nParticipate in vendor discussions, evaluate and recommend equipment product specifications and arrange equipment, material purchase, with the help of internal subject matter experts.\nUpdate and maintain engineering documents and files in accordance with company policy.\nResponsible for identifying and addressing line issues including but not limited to manufacturing process and component non-conformances, Deviations, Equipment inefficiencies.\nEmploy Design for Manufacturing/Assembly (DFx) during product development and manufacturing process development.\nDesign, develop and procure tooling, fixtures, and equipment in Solidworks.\nEnsure adherence to the applicable Standard Operating Procedures of the Quality System.\nQualification and Experience\nMinimum: BS or MS in Mechanical Engineering or equivalent and 3 Years of experience\nHighly Desirable: Experience in medical device industry and pharmaceutical development experience.\nSome experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualifications desirable.\nAbility to deploy Lean Manufacturing and Six-sigma principles for continuous improvement.\nExperience with applicable regulatory, QA, cGMP and industry best practices (ISO, ASTM and ICH standards).\nPrior experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays and nebulizers is preferred.\nLeadership and coaching skills.\nDemonstrated ability to communicate effectively and professionally with diverse stakeholders, including management, cross-functional teams, customers, and suppliers, across both technical and non-technical domains and multicultural environments.\nCompetencies\nCollaboration\nCustomer Centricity\nDeveloping Talent\nInnovation & Creativity\nProcess Excellence\nResult Orientation\nStakeholder Management\nStrategic 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