Specialist Manufacturing - Deviations

Responsibilities

• Lead the optimization of critical manufacturing processes and serve as a subject matter expert for specific equipment or systems.
• Own and maintain SOPs, batch records, and technical documentation to ensure compliance with cGMP and regulatory standards.
• Lead troubleshooting efforts for complex process or equipment issues, conducting root cause analyses and implementing preventive measures.
• Manage deviations, change controls, and CAPAs to ensure consistent product quality and regulatory compliance.
• Monitor manufacturing data and performance metrics to identify trends, risks, and opportunities for continuous improvement.
• Represent Manufacturing in cross-functional meetings, audits, and investigations.
• Provide formal training and mentorship to team members on complex manufacturing processes.

Requirements

• Doctorate degree OR Master's + 2 years experience OR Bachelor's + 4 years experience OR Associate's + 8 years experience OR High school + 10 years experience in Manufacturing Support.
• Experience in Quality Systems, specifically managing Major Deviations, CAPA, and CAPA Effectiveness Verification (EV).
• Proven expertise in conducting root cause investigations and driving cross-functional alignment.
• Strong technical writing skills with the ability to produce inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices.
• Experience working within a regulated GxP environment.

Preferred Qualifications

• Ability to perform advanced data trending and analysis to identify systemic quality risks and recurring failure modes.
• Experience engaging directly with manufacturing operations, including floor support and personnel interviews.
• Proven experience supporting regulatory inspections and interacting with regulatory agencies.
• Proficiency in leveraging digital tools, automation, and emerging technologies to improve investigation effectiveness.

Benefits

• Comprehensive employee benefits package including medical, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and an annual site shutdown.

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients living with serious illnesses. Since 1980, Amgen has pioneered innovations in Oncology, Inflammation, General Medicine, and Rare Disease, delivering life-changing medicines to millions of patients worldwide.