Principal Engineering Investigator

Lead end-to-end analytical and manufacturing-related investigations, including out-of-specification (OOS), out-of-trend (OOT), analytical deviations, data anomalies, and lab incidents. Ensure investigations are scientifically sound, compliant, and completed within defined timelines, meeting all cGMP and regulatory expectations (FDA, EMA, USP <797>/<800>, and 503B guidance). Apply structured problem-solving tools to determine true root causes and recommend durable corrective and preventive actions. Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams to collect data, review trends, and verify CAPA effectiveness. Review, approval, and/or author high-complexity investigation reports, technical assessments, and CAPA documentation to ensure technical accuracy and regulatory compliance. Identify and trend recurring issues, conducting periodic reviews to drive continuous improvement initiatives that enhance product quality and operational consistency. Perform thorough data review, analytical method assessments, equipment troubleshooting, and sample/laboratory workflow evaluation. Lead investigation, readiness, efforts and support internal and external audits, providing detailed summaries of investigation history, CAPA status, and site performance metrics. Collaborate with stakeholders to implement CAPAs, track progress, and verify effectiveness. Promote a culture of accountability and right-first-time documentation. Train others on Root Cause methodologies. Implement CAPA's with a mindset of driving the process with a Poke Yoke solution. Prepare clear, concise, and defensible investigation reports that meet internal quality standards and FDA/EMA regulatory expectations. Support internal, customer, and regulatory inspections by presenting investigation logic, risk reasoning, and CAPA justification.