Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. The MSAT Engineer I provides support for biotechnology manufacturing by generating supportive documentation and operational assistance of Right First Time manufacturing. Working under the guidance of multi-departmental staff, individuals in this role take part in process transfer, resolving technical issues, and providing documentation to Manufacturing and Quality Assurance staff. The MSAT Engineer I has a high degree of personal integrity and can work independently. The MSAT Engineer I continuously seeks subject matter experts' knowledge and integrates that knowledge into MSAT processes. Essential Job Duties/Responsibilities * Supports upstream and/or downstream Drug Substance commercialization and new product introduction assuring process fit to plant achieving right first time manufacturing in accordance with FDA/EMA/ICH regulations/guidance. * Lead root cause investigations, writing and completing Quality investigations and corrective actions, such as CAPAs, CRs, and Deviations * Lead troubleshooting efforts in manufacturing operations. Provide technical leadership to Manufacturing and other departments associated with GMP operations. * Support/Lead resolution of deviations, investigations, and process issues. * Develops and maintains strong relationships with Process Development (PD), Manufacturing, Quality Control (QC), Quality Assurance (QA), Engineering (ENG) and Project management (PM) to support robust launch, commercialization and batch disposition. * Drive continuous manufacturing improvements for greater ease of use by collaborating with end-users on their departmental needs including the establishment of metrics and KPI tracking. * Route MSAT documentation through Quality Management Software, and ensure that required documentation is reviewed and approved by key subject matter experts in a timely manner Skills * Strong technical skills with an emphasis on applying the needs of end-users to manufacturing processes * Strong collaborative skills with an emphasis on seeking the advisement and gaining the consensus of subject matter experts * Strong analytical problem solving skills to support technical transfer of new products Required QUALIFICATIONS * 0-3 years of relevant industry experience * BS/MS in engineering * Experience with GMP manufacturing or other scientific laboratories procedures * Demonstrated proficiency with Microsoft applications * Demonstrated proficiency in collaborating with various subject matter experts with effective communication skills necessary to interact with internal stakeholders Preferred * Experience with SharePoint * Experience with Quality Management Software, such as TrackWise Digital * Experience with Upstream and/or Downstream manufacturing operations and equipment Compensation $66,960 - $92,070 Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood@oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>