Senior Specialist – Contamination Control and Investigations

Role: Senior Specialist in Contamination Control and Investigations at Amgen's biologics manufacturing site, leading contamination risk management, investigations, and compliance efforts. Responsibilities: manage and lead complex deviation investigations related to microbial excursions, environmental monitoring, and aseptic processes; develop and optimize contamination control strategies; represent the site in industry networks; support inspections, audits, and regulatory responses; perform trend analyses to identify systemic risks; mentor investigators and collaborate across functions including Microbiology, Engineering, and Quality. Requirements: Doctorate with 2+ years, Master's with 4+ years, Bachelor's with 6+ years, or equivalent experience in microbiology, sterility assurance, or manufacturing within biotech/pharma; strong knowledge of GMP, contamination control programs, and regulatory expectations (FDA, EMA, Annex 1); experience with investigations, root cause analysis, and quality systems like Veeva QMS; excellent communication and cross-functional collaboration skills. Preferred: 7+ years of industry experience, microbiology background, project management skills, and familiarity with environmental/utility monitoring and aseptic processing. HighValue: biologics, contamination control, investigations, GMP compliance, regulatory inspections, and risk management in a cGMP manufacturing environment. Work setup: not specified but likely onsite with potential for hybrid arrangements.