Specialist Manufacturing Environmental and 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.

Specialist Manufacturing Environmental & Contamination Control

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:

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.

About Us

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.For more information, visit www.amgen.com and follow us on www.twitter.com/amgen