Manufacturing Investigation Lead – Deviation & CAPA

Amgen SA; Thousand Oaks (CA); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen Thousand Oaks is seeking a Specialist Manufacturing to investigate deviations across manufacturing, QA, and supply chain, determining scope, root cause, and effective CAPAs. You will collaborate with cross‑functional teams to ensure regulatory alignment and robust documentation.

You will lead investigations, present findings to regulators and internal auditors, and drive process improvements while mentoring teams and maintaining clear technical communications across functions.

Qualifications

• Doctorate degree required.
• Master’s degree with 2 years manufacturing experience.
• Bachelor’s degree with 4 years manufacturing experience.
• Associate’s degree with 8 years manufacturing experience.
• High school diploma / GED with 10 years manufacturing experience.
• 5+ years related work experience in biotech or pharmaceutical industry.
• Degree in Science or Engineering.

Responsibilities

• Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process
• Defend investigations to regulatory inspectors and internal auditors
• Present complex topics clearly to large and small groups at all levels in the company
• Build effective relationships across functions
• Clear and concise technical writing

Job description

Amgen Thousand Oaks is seeking a Specialist Manufacturing to investigate deviations across manufacturing, QA, and supply chain, determining scope, root cause, and effective CAPAs. You will collaborate with cross‑functional teams to ensure regulatory alignment and robust documentation.

You will lead investigations, present findings to regulators and internal auditors, and drive process improvements while mentoring teams and maintaining clear technical communications across functions.