Investigator I/II

Role: Investigator II within Technical Operations, responsible for independently managing moderate- to high-complexity investigations related to manufacturing, facilities, engineering, equipment, and validation systems in a biopharma setting. Objectives include assessing product quality, patient safety, and regulatory compliance through root cause analysis, risk assessments, and robust investigation documentation. Responsibilities encompass leading end-to-end investigations, analyzing manufacturing and environmental data, supporting product disposition, and contributing to continuous improvement and regulatory readiness. Requirements: BS/BA in engineering, science, or related field; 4-6 years of cGMP experience in biotech, pharma, or regulated industries; expertise in investigation methodologies, risk assessment, and review of manufacturing records; proficiency in eQMS systems; strong technical writing and cross-functional collaboration skills. Preferred: experience with biologics, cell therapies, or gene therapies, and supporting regulatory inspections. The role involves collaboration with subject matter experts, supporting audits, and ensuring compliance with quality standards. Location: Raritan, NJ, with the need for compliance with regulations and data integrity standards.