Manager, Manufacturing Environmental and Contamination Control
Amgen
June 26, 2026
On-site
West Greenwich, RI
$106,148 - $143,612 USD yearly
Operations
Manager Manufacturing Environmental & Contamination Control
What you will do
- Lead day-to-day delivery of deviation records and investigations, ensuring Deviation Owners and FAOs execute with rigor, speed, and compliance—especially for microbial and EM-related events.
Responsibilities
- Directly manage Deviation Owners and coordinate Process Specialists.
- Ensure clear ownership, appropriate workload planning, and timely movement of records.
- Oversee deviation lifecycle: initiation → triage → investigation → closure; ensure records are complete, accurate, and audit-ready.
- Provide investigation quality oversight: robust root cause analysis, appropriate scoping/impact assessment, challenge superficial conclusions.
- Microbial event focus: ensure SME engagement (QC Micro, aseptic SMEs); verify investigations reflect true contamination risk and classification reflects risk.
- Facilitate alignment among FAO, QA, and Deviation Owner; ensure classification/disposition decisions are documented.
- Ensure CAPA assignment, ownership, effective completion, and linkage to root cause.
- Lead daily deviation triage for environmental/contamination control events; prioritize high-risk items; ensure tracking/reporting and allocate resources.
- Support inspection readiness and defend scientific rationale.
- Drive continuous improvement; streamline investigations using AI/digital tools.
- Track key performance metrics: on-time closure (OTD), aging backlog, investigation effectiveness, CAPA cycle time, audit/inspection observations.
Basic Qualifications
- High school/GED + 12 years manufacturing/operations OR Associate + 10 years OR Bachelor + 5 years OR Master + 3 years OR Doctorate.
- Plus experience directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications
- BS/BA or equivalent (science/engineering/psychology preferred); 8+ years pharmaceutical industry experience.
- Experience applying AI/digital tools; strong knowledge of deviation management, root cause analysis, and GMP compliance.
- Ability to drive execution through others, manage competing priorities, influence cross-functional teams, and coach performance.
Total Rewards Plan (if eligible)
- Comprehensive employee benefits: retirement/savings, medical/dental/vision, life/disability, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field roles), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application instructions
- In submitted materials, you may redact age-identifying information (age, date of birth, or school attendance/graduation dates); you will not be penalized.
What you will do
- Lead day-to-day delivery of deviation records and investigations, ensuring Deviation Owners and FAOs execute with rigor, speed, and compliance—especially for microbial and EM-related events.
Responsibilities
- Directly manage Deviation Owners and coordinate Process Specialists.
- Ensure clear ownership, appropriate workload planning, and timely movement of records.
- Oversee deviation lifecycle: initiation → triage → investigation → closure; ensure records are complete, accurate, and audit-ready.
- Provide investigation quality oversight: robust root cause analysis, appropriate scoping/impact assessment, challenge superficial conclusions.
- Microbial event focus: ensure SME engagement (QC Micro, aseptic SMEs); verify investigations reflect true contamination risk and classification reflects risk.
- Facilitate alignment among FAO, QA, and Deviation Owner; ensure classification/disposition decisions are documented.
- Ensure CAPA assignment, ownership, effective completion, and linkage to root cause.
- Lead daily deviation triage for environmental/contamination control events; prioritize high-risk items; ensure tracking/reporting and allocate resources.
- Support inspection readiness and defend scientific rationale.
- Drive continuous improvement; streamline investigations using AI/digital tools.
- Track key performance metrics: on-time closure (OTD), aging backlog, investigation effectiveness, CAPA cycle time, audit/inspection observations.
Basic Qualifications
- High school/GED + 12 years manufacturing/operations OR Associate + 10 years OR Bachelor + 5 years OR Master + 3 years OR Doctorate.
- Plus experience directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications
- BS/BA or equivalent (science/engineering/psychology preferred); 8+ years pharmaceutical industry experience.
- Experience applying AI/digital tools; strong knowledge of deviation management, root cause analysis, and GMP compliance.
- Ability to drive execution through others, manage competing priorities, influence cross-functional teams, and coach performance.
Total Rewards Plan (if eligible)
- Comprehensive employee benefits: retirement/savings, medical/dental/vision, life/disability, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field roles), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application instructions
- In submitted materials, you may redact age-identifying information (age, date of birth, or school attendance/graduation dates); you will not be penalized.