Specialist Manufacturing Environmental and Contamination Control

Career Category

Operations

Job Description

Responsibilities:

Technical Ownership of Microbial Investigations

• 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

Accountability for Investigation Quality & CAPA

• 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

Decision Authority – Product & Process Risk

• 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

Deviation Classification & Designation Support

• Contribute to Major vs Minor classification decisions based on impact and controls

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

Resource & Investigation Oversight

• Ensure:

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

  • Adequate resources are deployed to support investigation depth

Cross-Functional Integration (Critical for Microbial Events)

• 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

Engagement Across Deviation Lifecycle

• Maintain active involvement from triage through closure

• Ensure:

  • Timely decisions

  • Strong documentation

  • Alignment across stakeholders

Inspection Readiness & Defense

• Act as key spokesperson during inspections for microbial events

• Must:

  • Clearly articulate root cause

  • Defend classification rationale

  • Demonstrate CAPA effectiveness

Key Differentiators – Microbial FAO vs Standard FAO

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] 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

• Bachelor’s degree and 4 years of directly related experience OR

• Master’s degree and 2 years of directly related experience OR

• Doctorate degree

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 (Microbiology/Life Science)

• 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 & communicate clearly under inspection pressure  

• Strong understanding of EM program design and limitations, objectionable organisms & contamination pathways and aseptic processing risk

• Knowledge of network and industry trends in managing and responding to microbial contamination risk

What you can expect from 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.

Application deadline

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

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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 ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Salary Range

107,545.40USD -145,502.60 USD