Senior Specialist – Contamination Control and Investigations

Amgen • Holly Springs, NC

9d • Onsite

About The Position

Amgen is seeking a Senior Specialist – Contamination Control and Investigations for its newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility. This facility combines single-use technologies with traditional stainless steel equipment for maximum operational flexibility and integrates industry 4.0 capabilities with sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. In this role, you will be a key member of the team responsible for advancing the site's Contamination Control Strategy and leading complex contamination-related investigations. You will interface between GMP manufacturing teams and various stakeholder groups, including Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing, and Quality. The position focuses on proactively identifying, assessing, controlling, and continuously improving contamination risks, leading high-impact investigations, and supporting site-wide inspection readiness.

Requirements

• Doctorate degree & 2 year 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
• Strong background in contamination control, microbiology, sterility assurance, manufacturing, investigations, and quality systems
• 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.
• Drive 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
• 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
• Education Level: No Education Listed