Specialist Manufacturing Environmental and Contamination Control

Location: West Greenwich

** 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…