Quality Control Environmental Monitoring Scientist II

Role: Subject Matter Expert in industrial/pharmaceutical Environmental Monitoring at Novo Nordisk’s manufacturing site, primarily overseeing microbiological control and compliance programs. Responsibilities include leading the site EM program, managing aseptic contamination controls, conducting risk assessments, supporting audits, handling deviations and CAPAs, and reviewing data/trending reports. The role demands technical expertise in microbiology, GMP compliance, and cross-functional collaboration for support on EM program setup, investigations, and qualification activities. Qualifications: Bachelor’s in microbiology or related field with a minimum of 8 years’ experience in biopharma manufacturing; advanced degrees preferred with fewer years of experience. Proven leadership in environmental monitoring, project management, and microbiology techniques is required. High-Value: Focus on aseptic processes, microbiological assays, GMP, and compliance in a biologics manufacturing environment. Physical demands include site inspections and working in diverse environments, with minimal travel (~0-10%). The role involves independent judgment, technical mentoring, and ensuring adherence to regulatory standards.