Specialist Manufacturing Environmental and Contamination Control

Career Category

Operations

Specialist Manufacturing Environmental & Contamination Control

Accountable technical authority for microbial‑related deviations within their functional domain, ensuring scientifically robust investigations, risk‑based decisions, and effective CAPA implementation aligned to GMP and regulatory expectations.

• Provide functional SME oversight for microbial events, including Environmental Monitoring excursions and bioburden/endotoxin/contamination signals.
• Ensure investigations are scientifically sound and microbiologically justified.
• Identify root causes with supporting data and rationale.
• Ensure thorough root cause analysis and appropriate corrective, preventive, and eradication actions to prevent recurrence.
• Validate that each root cause has a corresponding action and that CAPAs are effective, risk‑based, and sustainable.
• Accountable for decision and documented rationale for continued processing or disposition.
• Collaborate with QA to ensure decisions are defensible, risk‑appropriate, and aligned with GMP expectations.
• Contribute to major vs minor classification decisions based on impact and controls, ensuring classification reflects true microbiological risk.
• Ensure appropriate SME engagement and that adequate resources are deployed to support investigation depth.
• Work closely with QC Microbiology, Manufacturing, and QA to integrate cross‑functional efforts.
• Maintain active involvement from triage through closure, ensuring timely decisions, strong documentation, and alignment across stakeholders.
• Act as key spokesperson during inspections for microbial events, clearly articulating root cause, defending classification rationale, and demonstrating CAPA effectiveness.

• 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 or 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 understanding of EM program design and limitations, objectionable organisms and contamination pathways, and aseptic processing risk.
• Knowledge of network and industry trends in managing and responding to microbial contamination risk.

• Competitive salary based on experience and qualifications.
• Amgen Total Rewards Plan, including health and welfare plans, retirement and savings plan, group medical, dental, vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program or sales‑based incentive plan for eligible roles.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where applicable.

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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 to individuals with disabilities for the application process, interview, job functions, and benefits. Please contact us to request accommodation.