Senior Specialist – Contamination Control and Investigations

Senior Specialist – Contamination Control and Investigations

In this vital role, you will serve as a key member of the team responsible for advancing the site's Contamination Control Strategy while leading complex contamination-related investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between GMP manufacturing teams and stakeholder groups including Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing, and Quality.

This position is responsible for ensuring contamination risks are proactively identified, assessed, controlled, and continuously improved while leading high-impact investigations and supporting inspection readiness across the site.

• Manage complex contamination-related deviation investigations including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events, and product quality investigations.
• Represent the site in the Contamination Control Network and collaborate with network partners to align contamination control strategies, standards, lessons learned, and best practices while driving implementation of network initiatives and continuous improvement opportunities.
• Provide technical leadership for contamination control‑related audit and inspection responses, partnering with cross‑functional teams to assess observations, develop risk‑based remediation strategies, and ensure effective and sustainable corrective actions.
• Support development, implementation, maintenance, and continuous improvement of the site's contamination control strategy.
• Drive improvements to contamination control programs, contamination risk assessments, and investigation processes.
• Lead contamination control inspection readiness activities and serve as a contamination control SME during regulatory inspections, internal audits, and management reviews.
• Present contamination control strategies, investigation outcomes, and risk assessments to inspectors, auditors, and site leadership.
• Perform trend analysis of environmental monitoring, utilities, contamination‑related deviations, and quality events to identify emerging risks.
• Coordinate and effectively lead cross‑functional teams through complex contamination‑related investigations and complete milestones on schedule.
• Identify systemic contamination risks and drive site‑wide corrective and preventive actions.
• Partner with CCS network leads, QC Microbiology, Manufacturing, Engineering, Process Development, and Quality organizations to strengthen contamination prevention programs.
• Apply advanced root cause analysis methodologies and quality risk management principles.
• Navigate ambiguity and provide a structured, science‑based problem‑solving approach.
• Develop metrics and tracking tools to ensure on‑time closure of investigations and ongoing effectiveness of contamination control programs.
• Mentor investigators and operational personnel on contamination control principles, contamination risk management, and investigation excellence.
• Serve as a site SME for contamination control principles, contamination risk management, and contamination prevention strategies.

• Doctorate degree & 2 years of directly related experience
• Master's degree & 4 years of directly related experience
• Bachelor's degree & 6 years of directly related experience
• Associate's degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience

• 7+ years related work experience (microbiology, sterility assurance, manufacturing, process development, engineering, or quality assurance) in the biotechnology or pharmaceutical industry with progressively increasing responsibility.
• Strong experience with contamination control programs, contamination risk management, investigations, quality systems, and compliance.
• Degree in Science or Engineering. Microbiology studies or major a plus!
• Experience developing, implementing, or maintaining contamination control strategies and contamination risk management programs.
• Experience leading highly complex…