Specialist Manufacturing Deviation Owner Environmental and Contamination Control

Responsibilities

• Manage end-to-end deviation records, including investigation, documentation, and resolution to ensure regulatory compliance.
• Act as a technical writer to articulate complex manufacturing events into clear, inspection-ready documentation.
• Define and execute investigation strategies, including shopfloor observations, Gemba activities, and interviews.
• Conduct root cause analyses (RCA) and ensure scientific justification for all conclusions.
• Lead the identification and development of Corrective and Preventive Actions (CAPA) and support effectiveness verification.
• Coordinate with cross-functional teams including Quality Assurance, QC, Process Development, and Engineering.
• Serve as a Subject Matter Expert (SME) during regulatory inspections to defend investigation rationale.
• Support deviation trending and data analysis to identify recurring issues and implement prevention strategies.

Requirements

• Bachelor’s degree and 4 years of directly related experience, OR
• Associate degree and 8 years of directly related experience, OR
• High school diploma/GED and 10 years of directly related experience, OR
• Master’s degree and 2 years of directly related experience, OR
• Doctorate degree.
• Strong technical writing and root cause analysis skills.
• Experience with CAPA development and maintaining data integrity.
• Ability to coordinate effectively across multiple functional departments.

Preferred Qualifications

• BS/BA in Science, Engineering, or Psychology.
• 8+ years of experience within the pharmaceutical industry.
• Experience applying AI or digital tools to streamline workflows and generate insights.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, leveraging human genetics and biologics manufacturing expertise to improve health outcomes worldwide.