Specialist Manufacturing Environmental and Contamination Control

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

Since 1980, Amgen has pioneered the world of biopharma, fighting the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. Through a broad and deep pipeline, we develop medicines for cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions.

In this vital role you will be the accountable technical authority for microbial-related deviations (e.g., environmental monitoring excursions, bioburden, contamination events) within your functional domain. You will conduct scientifically robust investigations, make risk‑based decisions, and implement effective CAPA in line with GMP and regulatory expectations.

• Technical ownership of microbial investigations
• Provide functional SME oversight for microbial events, including:
  • Environmental Monitoring excursions
  • Bioburden / endotoxin / contamination signals
• Ensure investigations are scientifically sound and microbiologically justified
• Root‑cause identification with supporting data and rationale
• Ensure thorough root‑cause analysis and appropriate corrective/preventive actions to prevent recurrence
• Validate that each root cause has a corresponding action and CAPAs are effective, risk‑based, and sustainable
• Decision authority for product & process risk; document rationale for continued processing or disposition
• Collaborate with QA to ensure decisions are defensible, risk‑appropriate, and aligned with GMP expectations
• Support deviation classification and designation – contribute to major vs minor decisions based on impact and controls
• Resource and investigation oversight – engage relevant SMEs and deploy adequate resources
• Cross‑functional integration – work closely with QC Microbiology, Manufacturing, and QA; embedded within the ECC model with dedicated microbial expertise
• Engage throughout the deviation lifecycle from triage through closure
• Inspection readiness and defense – act as spokesperson, clearly articulate root cause, defend classification rationale, and demonstrate CAPA effectiveness

All listed tasks and responsibilities are essential functions of this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

• 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 in Microbiology/Life Sciences
• 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, and communicate clearly under inspection pressure
• Strong knowledge of EM program design, 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 – 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

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will provide reasonable accommodation for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive other employment benefits.