Manager Manufacturing Environmental & Contamination Control

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.

Responsibilities

The Front-Line Manager

• 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.

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 12 years of manufacturing or operations experience OR

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

• Bachelor’s degree and 5 years of manufacturing or operations experience OR

• Master’s 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

Preferred Qualifications

• 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 coaching for a team of professionals

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

.

Salary Range