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The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role The Technical Operations Process Engineer provides direction and support to the manufacturing area utilizing industry standard problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include, but are not limited to, development / definition of new process specifications, reduction of variation, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, SOPs, etc.), validation of new or improved manufacturing processes / equipment and integrating new products from R&D into manufacturing. This position will be located onsite in Athens, Ohio. The Responsibilities Characterize, optimize, and validate manufacturing processes to improve efficiency and robustness of current processes. Assist / Lead in multi-site technical transfer activities from R&D to Operations Develop / characterize material property specification for critical to quality raw materials Assists Supply Chain and Supplier Quality Engineering in qualifying new vendor's for established raw materials Design, characterize and validate new processes or equipment to improve manufacturability Leads / supports evaluation of NC's, CAPA's, Failure Investigation and Deviation arising from Manufacturing for complex manufacturing processes. Owns and executes assigned deliverables from R&D development meetings as it relates to scale up and current production capabilities in Mfg. Develop / characterize testing or performance specification for manufacturing processes Executes all tasks in accordance with QuidelOrtho's Quality System and carries out duties in compliance with established business policies. Liaison for contract manufactures Establishment as subject matter expert for all manufacturing processes at the Athen's facility Multi-site travel will be required, up to 25%. Perform other duties & projects as assigned. The Individual Required: BA/BS in engineering or related field and 3-5 years' experience within a cGMP manufacturing environment or equivalent. Strong analytical and problem-solving skills Strong knowledge of process optimization, scale up and standardization. Well versed in time management and ability to manage multiple projects at a time Good organizational skills, and the ability to manage multiple tasks Ability to execute and analyze Desing of Experiments (DOE's) and make data driven decisions independently Ability to develop new processes and set specifications Characterize materials and set specifications Troubleshoot problems Write and execute associated validations Ability to work within cross-functional teams / sites Good communication skills, written and verbal. Knowledge of relevant analytica