Specialist Manufacturing Environmental and Contamination Control

Join Amgen’s mission of serving patients. At Amgen, if you feel you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

In this vital role you will be accountable technical authority for microbial-related deviations (e.g., EM excursions, bioburden, contamination events) within your functional domain, ensuring scientifically robust investigations, risk-based decisions, and effective CAPA implementation aligned to GMP and regulatory expectations.

• Technical ownership of microbial investigations
  • Provide functional SME oversight for microbial events, including:
  • Environmental Monitoring (EM) excursions
  • Bioburden / endotoxin / contamination signals
  • Ensure investigations are scientifically sound and microbiologically justified
  • Ensure true root‑cause identification with supporting data and rationale
• Accountability for investigation quality & CAPA
  • Ensure thorough root‑cause analysis (RCA)
  • Implement appropriate Corrective and Preventive Actions (CAs/PS) to prevent recurrence
  • Validate that each root cause has a corresponding action and that CAPAs are effective, risk‑based, and sustainable
• Decision authority for product and process risk
  • Accountable for documented rationale for continued processing or disposition
  • Collaborate with QA to ensure decisions are defensible, risk‑appropriate, and aligned with GMP expectations
• Deviation classification & designation support
  • Contribute to major vs minor classification decisions based on impact and controls
  • Ensure classification reflects true microbiological risk
• Resource & investigation oversight
  • Ensure appropriate SME engagement (e.g., Microbiology, QC, MFG)
  • Adequate resources are deployed to support investigation depth
• Cross‑functional integration (critical for microbial events)
  • Work closely with QC Microbiology (EM data interpretation), Manufacturing (aseptic behavior, execution), and QA (final decision authority)
  • Embedded within ECC model with dedicated microbial expertise and deviation FAO support
  • Own the ECC Genba program and ensure cross‑functional participation, effective engagement, and actionable outcomes
• Engagement across deviation lifecycle
  • Maintain active involvement from triage through closure
  • Ensure timely decisions, strong documentation, and alignment across stakeholders
• Inspection readiness & defense
  • Act as key spokesperson during inspections for microbial events
  • Clearly articulate root cause, defend classification rationale, and demonstrate CAPA effectiveness

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self‑starter with the following qualifications.

• High school diploma/GED and 10 years of directly related experience
• Associate’s degree and 8 years of directly related experience
• Bachelor’s degree and 4 years of directly related experience
• Master’s degree and 2 years of directly related experience
• Doctorate degree

• BS/BA or equivalent (Microbiology/Life Science)
• 8+ years of microbiology industry experience in the pharmaceutical industry
• Experience applying AI or other digital tools to generate insights and streamline workflows
• Strong understanding of GxP and deviation management processes and microbiology/contamination control principles
• Ability to apply risk‑based decision making, influence cross‑functional teams & communicate clearly under inspection pressure
• Strong understanding of EM program design and limitations, objectionable organisms & contamination pathways and aseptic processing risk
• Knowledge of network and industry trends in managing and responding to microbial contamination risk

• A 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
• Flexible work models where possible