Senior F&E Engineer: Environmental & Contamination Control

Amgen SA; West Greenwich (RI); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen in the United States is seeking a Sr. Engineer for F&E Environmental & Contamination Control to lead deviation investigations, own the end-to-end process, and ensure investigations are scientifically justified and inspection-ready within a regulated manufacturing environment.

The role requires strong technical writing, RCA leadership, and cross-functional collaboration with QA, automation, facilities, process development, and capital projects, while driving CAPAs and continual improvement

Qualifications

• Extensive experience in pharmaceutical/biotech manufacturing environments.
• Strong technical writing and analytical problem-solving skills.
• Ability to influence and lead cross-functional teams without direct authority.
• Experience applying AI, analytics, or digital tools to support investigations.
• Knowledge of facilities & engineering systems and commissioning & qualification.

Responsibilities

• Deviation Ownership & Execution: translate events into concise, technically accurate documentation.
• Lead deviation investigations from initiation through closure with quality system compliance.
• Maintain data integrity and timely progression of deviations.
• Prioritize multiple investigations in a dynamic manufacturing environment.
• Technical Investigation & Root Cause Analysis: develop investigation strategies for equipment, utility, and automation events.
• Conduct field assessments, walkdowns, and system reviews to gather evidence.
• Lead RCA sessions with cross-functional stakeholders.
• Corrective and Preventive Actions (CAPA): develop robust CAPAs addressing immediate and systemic causes.
• Support effectiveness verification and long-term monitoring.
• Identify opportunities to improve reliability and maintenance practices.
• Cross-Functional Collaboration: partner with Manufacturing, QA, QC, Automation, Facilities, ETA, Process Development, Capital Projects, Global Engineering.
• Drive alignment and data-driven decision-making across stakeholders.
• Engage SMEs and challenge assumptions.
• Documentation & Technical Decision Making: develop narratives and assessments with event chronology, causality, risk, and conclusions.
• Support impact assessments for equipment modifications, utility changes, and automation updates.
• Ensure alignment with QMS requirements and inspection expectations.
• Regulatory & Inspection Readiness: serve as SME during regulatory inspections and audits.
• Defend technical conclusions and risk-based decisions.
• Support inspection preparation and response as needed.
• Data Analysis & Continuous Improvement: analyze deviation trends and identify recurring issues.
• Leverage data analytics and digital tools to improve investigation efficiency.
• Contribute to reliability and inspection-readiness initiatives.

Skills

Technical writing

Root Cause Analysis

Deviation ownership

Cross-functional collaboration

Data analysis

Regulatory readiness

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Doctorate

Tools

DeltaV

BAS

PI

Job description

Amgen in the United States is seeking a Sr. Engineer for F&E Environmental & Contamination Control to lead deviation investigations, own the end-to-end process, and ensure investigations are scientifically justified and inspection-ready within a regulated manufacturing environment.

The role requires strong technical writing, RCA leadership, and cross-functional collaboration with QA, automation, facilities, process development, and capital projects, while driving CAPAs and continual improvement