Senior Specialist – Contamination Control and Investigations

Amgen • Holly Springs, NC

10d • Onsite

About The Position

This role serves 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. The position involves communication and interface between GMP manufacturing teams and stakeholder groups including Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing, and Quality. The role 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.

Requirements

• Doctorate degree & 2 year of directly related experience Or Master's degree & 4 years of directly related experience Or Bachelor's degree & 6 years of directly related experience Or Associate's degree & 10 years of directly related experience Or High school diploma / GED & 12 years of directly related experience
• Strong background in contamination control, microbiology, sterility assurance, manufacturing, investigations, and quality systems with demonstrated technical leadership and cross-functional collaboration skills.

Nice To Haves

• 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 contamination-related investigations and performing contamination risk assessments to support quality and manufacturing operations.
• Knowledge of Annex 1, FDA, EMA, and global GMP requirements related to contamination control and sterility assurance.
• Experience using Veeva QMS for deviation investigations and CAPAs.
• Experience presenting during regulatory inspections and internal audits.
• Experience assessing and responding to contamination control-related audit or inspection observations and driving sustainable corrective actions.
• Demonstrated project management ability.
• Strong knowledge of environmental monitoring, utility monitoring, aseptic processing, and contamination prevention principles.
• Excellent written and verbal communication skills.
• Ability to work in a matrix environment and build strong cross-functional partnerships.
• Strong interpersonal and technical leadership skills.

Responsibilities

• 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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior