Specialist Manufacturing Environmental and Contamination Control

Amgen Specialist Manufacturing Environmental & Contamination Control

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like 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.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

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

Responsibilities:

• 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

• Ensure:

  • Thorough root cause analysis (RCA)

  • Appropriate Corrective / Preventive Actions (CA/PA/EV) to prevent recurrence

• Validate that:

  • Each root cause has a corresponding action

  • 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

• Ensure classification reflects true microbiological risk (not convenience or precedent)

• Ensure:

  • Appropriate SME engagement (e.g., Microbiology, QC, MFG)

  • Adequate resources are deployed to support investigation depth

• Work closely with:

  • QC Microbiology (EM data interpretation)

  • Manufacturing (aseptic behavior, execution)

  • 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

• Maintain active involvement from triage through closure

• Ensure:

  • Timely decisions

  • Strong documentation

  • Alignment across stakeholders

• Act as key spokesperson during inspections for microbial events

• Must:

  • Clearly articulate root cause

  • Defend classification rationale

  • Demonstrate CAPA effectiveness

• Demonstrate Microbial science depth

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

What we expect of you

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

Basic Qualifications

• High school diploma/GED and 10 years of directly related experience OR

• Associates degree and 8 years of directly related experience OR

• B…