Manufacturing Engineer

OUR WORK MATTERSAt Kindeva we make products that save lives ensuring better health and well-being for patients around the worldROLE SUMMARYThis is a great opportunity to support commercial manufacturing operations within a 24/7 pharmaceutical manufacturing environment by providing technical support troubleshooting processes continuous improvement and project execution. This individual will be supporting assigned production lines driving corrective actions and executing engineering deliverables that improve safety quality reliability and RESPONSIBILITIESManufacturing Support (24/7 Facility)Provide daily technical support for assigned production troubleshooting of equipment process and quality in root cause investigations and corrective significant production risks line recovery efforts during downtime visibility online performance downtime losses and recurring issuesProcess Ownership & OptimizationServe as engineering owner for assigned manufacturing assigned action items and corrective actions to OEE uptime yield scrap reduction and throughput and implement process validation qualifications and change-control technical documentation and engineering recordsCAPA Quality and ComplianceSupport investigations deviations and assigned quality actions by committed due compliance with cGMP audits and inspection readiness in Engineering Change Control processes)Project ExecutionExecute assigned engineering projects and multiple assignments project risks and delays agreed-upon completion regular status updates to implementation of capital and continuous improvement projectsQUALIFICATIONSRequiredBachelors degree in mechanical electrical systems engineering manufacturing or other engineering discipline from an accredited institution or a bachelors degree with manufacturing experience.3 years in pharma/biotech/medical device manufacturing is knowledge of root cause investigation methodologies and corrective action knowledge of cGMP requirements quality systems change control deviations and CAPA troubleshooting manufacturing processes equipment and production to manage multiple assignments and priorities ability to execute engineering projects from concept through written and verbal communication supporting manufacturing operations in a production with Microsoft Office applications and engineering documentation to work effectively with Production Maintenance Quality Validation and Engineering to provide support within a 24/7 manufacturing operation when business conditions require additional Familiarity with automated systems and with Lean Manufacturing Six Sigma DMAIC Kaizen SPC or DOE participating in equipment qualifications validations and commissioning with RCAs CAPAs deviations and investigation supporting OEE downtime reduction scrap reduction and productivity improvement in inhalation or transdermal manufacturing is preferred.#LI-Onsite#JJ