Production Expert II

Our Team, Your Impact This position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production, Engineering, Quality Control (QC) Laboratory, and related support areas. How You’ll Spend Your Day Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations/nonconformances/atypical events), ensuring clear problem statements, accurate timelines, and timely closure. Coordinate event triage and immediate actions, including containment and escalation; support batch disposition decisions. Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (batch records, equipment/maintenance logs, MES/SCADA/historian data, calibrations, environmental monitoring, test results). Facilitate cross-functional root cause analysis using structured tools (5-Why, fishbone, fault tree) and document conclusions and product impact assessments. Define, document, and track CAPAs with due dates and effectiveness checks; support on-the-floor verification. Prepare investigation/CAPA records; support trending and continuous improvement; support audit/inspection readiness. Complete training requirements and maintain 100% compliance; perform work safely per cGMP and SOPs. Education/Certification/Experience Master’s or Ph.D. in a scientific or engineering discipline with relevant experience in pharmaceutical manufacturing/engineering/QC investigations; OSD experience preferred. Experience using electronic quality and data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending, AI tools) preferred. Skills/Knowledge/Abilities OSD manufacturing and complex process/equipment knowledge. Strong technical writing/documentation using GDP. Knowledge of cGMP, quality systems, and data integrity. Root cause analysis using 5-Why/fishbone/fault tree. Ability to interpret and trend data using eQMS/MES/LIMS/historian/Excel. Cross-functional facilitation/communication; proficiency in Microsoft Office (Word, PowerPoint, Excel, SharePoint); confidentiality and discretion. Application Instructions Apply through the internal career site on Twist. #J-18808-Ljbffr Scorpion Therapeutics