Manager Manufacturing Environmental and Contamination Control

Manager Manufacturing Environmental & Contamination Control

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

• Direct Management of Deviation Owners & FAO's
  • Lead and coordinate Deviation Owners (execution) and Process Specialists (technical oversight)
  • Ensure clear ownership assignment and appropriate planning and distribution of workload, timely movement of records
• Deviation Lifecycle Execution
  • Oversee initiation triage, investigation, and closure
  • Ensure records are complete, accurate, and audit-ready
  • Remove barriers to timely closure and escalation
• Investigation Quality Oversight
  • Ensure robust root cause analysis (RCA) and appropriate scoping and impact assessment
  • Challenge teams to avoid superficial or convenience-based conclusions
• Microbial Event Execution (Critical Focus)
  • Ensure microbial deviations receive appropriate SME engagement (QC Micro, aseptic SMEs)
  • Verify investigations reflect true contamination risks and classification reflects risk (not bias or precedent)
• Decision Facilitation & Alignment
  • Facilitate alignment between FAO, QA, and Deviation Owner
  • Ensure decisions (classification, disposition) are clearly documented
• CAPA Execution & Follow-Through
  • Ensure CAPAs are assigned, owned, and completed effectively
  • Confirm clear linkage between root cause and actions
• Triage & Prioritization
  • 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
• Inspection Readiness Support
  • Prepare team to speak to deviations directly and defend scientific rationale
  • Ensure records are inspection-ready at all times
• Continuous Improvement
  • 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.
• Key Performance Metrics
  • On-time closure (OTD)
  • Aging backlog
  • Investigation effectiveness
  • CAPA cycle time
  • Audit/inspection observations

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative leader 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
• Bachelors degree and 5 years of manufacturing or operations experience OR
• Masters degree and 3 years of manufacturing or operations experience OR
• Doctorate degree
• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

• The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent
• BS/BA or equivalent (science/engineering/psychology preferred)
• 8+ years of experience in the pharmaceutical industry
• Experience applying AI or other digital tools to generate insights and streamline workflows
• Strong understanding of deviation management process, root cause analysis & GMP compliance
• Ability to drive execution through others, manage multiple competing priorities, influence cross-functional teams & provide performance management and…