GMP Manufacturing Engineer I — Biotech Impact

Amgen Inc.; Thousand Oaks (CA); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen is seeking an Engineer I to support manufacturing activities at the Thousand Oaks site. You will collaborate with Automation, Maintenance, Project Management, and Quality to ensure equipment reliability, safety, and compliance with cGMP standards.

The role emphasizes data-driven decision making, risk-based improvement, and mentoring of project teams within a team-based environment.

Qualifications

• Master’s degree or equivalent in engineering/manufacturing with experience.
• Alternate pathways: Bachelor’s with 2 years’ related experience; Associate’s with 6 years; or HS diploma with 8 years total experience.

Responsibilities

• Model leadership behaviors to create a positive working environment.
• Ensure equipment performance and reliability.
• Provide oversight for verification work by outsourced staff.
• Act as liaison between Engineering, Automation, Maintenance, Instrumentation and Quality Assurance.
• Ensure validation protocols are executed per cGMP and safety practices.
• Initiate and drive continuous improvement projects to completion.
• Mentor project teams using risk-based approaches.
• Participate in internal audits and develop business metric performance.

Skills

Strong communication

Technical writing

Facilitation and collaboration

Leadership

Risk-based thinking

Education

Master’s degree

Bachelor’s degree + 2 years engineering/manufacturing

Associate’s degree + 6 years engineering/manufacturing

High school diploma / GED + 8 years engineering/manufacturing

Tools

DeltaV

Rockwell

Plant information systems

Job description

Amgen is seeking an Engineer I to support manufacturing activities at the Thousand Oaks site. You will collaborate with Automation, Maintenance, Project Management, and Quality to ensure equipment reliability, safety, and compliance with cGMP standards.

The role emphasizes data-driven decision making, risk-based improvement, and mentoring of project teams within a team-based environment.