Manager Manufacturing Environmental and Contamination Control

Career Category:
Operations Job Description 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.

Let’s do this. Let’s change the world. In this vital role you will be responsible for day‑to‐day delivery of deviation records and investigations, ensuring Deviation Owners and FAOs execute with rigor, speed, and compliance, particularly for microbial and EM‑related events. This role shall report to the Senior Manager of the Environmental and Contamination Control (ECC) team.

• Lead and coordinate:

  • Deviation Owners (execution)

  • Process Specialists (technical oversight)

• Ensure:

  • Clear ownership assignment and appropriate planning and distribution of workload

  • Timely movement of records

• Oversee:
  Initiation → triage → investigation → closure

• Ensure records are complete, accurate, and audit‑ready

• Remove barriers to timely closure and escalation

• Ensure:

  • Robust root cause analysis (RCA)

  • Appropriate scoping and impact assessment

• Challenge teams to avoid superficial or convenience‑based conclusions

• Ensure microbial deviations receive appropriate SME engagement (QC Micro, aseptic SMEs)

• Verify:

  • Investigations reflect true contamination risks

  • Classification reflects risk (not bias or precedent)

• Facilitate alignment between:

  • FAO

  • QA

  • Deviation Owner

• Ensure decisions (classification, disposition) are clearly documented

• Ensure CAPAs are:

  • Assigned

  • Owned

  • Completed effectively

• Confirm clear linkage between root cause and actions

• Lead daily deviation triage for environmental and contamination control‑related events

• Prioritize high‑risk (e.g., microbial, major deviations)

• Ensure effective tools and business processes are in place for tracking and reporting record progress

• Allocate resources appropriately

• Prepare team to:

  • Speak to deviations directly

  • Defend scientific rationale

• Ensure records are inspection‑ready at all times

• Create a culture of continuous improvement among the ECC team and facilitate implementation of tools and processes that streamline the investigation process, making appropriate use of AI and other digital tools.

• On‑time closure (OTD)

• Aging backlog

• Investigation effectiveness

• CAPA cycle time

• Audit/inspection observations

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.

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.

• High school diploma/GED and 12 years of manufacturing or operations experience OR

• Associates degree and 10 years of manufacturing or operations experience OR

• Bachelor’s degree and 5…