Specialist Manufacturing Environmental and Contamination Control

Amgen • West Greenwich, RI

3d • $107,545 - $145,503

About The Position

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.

Requirements

• 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
• 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

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 and 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) and 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), and 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, and alignment across stakeholders.
• Inspection Readiness & Defense: Act as key spokesperson during inspections for microbial events. Must clearly articulate root cause, defend classification rationale, and demonstrate CAPA effectiveness.
• Key Differentiators – Microbial FAO vs Standard FAO: Demonstrate Microbial science depth.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level