Manufacturing Process Specialist – Continuous Improvement

Amgen; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Stock-based incentives

Flexible work models

Retirement plan

Job summary

Amgen is seeking an Associate Manufacturing professional to join the Thousand Oaks team. You will support preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate in Building 7.

You will work in cleanrooms and help set up critical equipment, ensuring smooth operations and adherence to GMP standards. You will participate in training, qualification activities, and continuous improvement initiatives while collaborating with cross-functional teams to deliver reliable

Qualifications

• Bachelor's degree or equivalent technical training in a related field.
• Experience in manufacturing environments with GMP exposure.
• Knowledge of aseptic operations in Grade 5 cleanrooms and CFRs.
• Strong technical writing and documentation skills.

Responsibilities

• Operate in classified cleanrooms, Grade 9 through Grade 5 environments.
• Set-up, CIP, and SIP of production equipment.
• Operate equipment on the production floor per SOPs.
• Monitor manufacturing processes and elevate issues to management.
• Support commissioning and qualification of new equipment.
• Coordinate improvement projects to drive efficiency.
• Own and manage minor deviations with on-time closure.
• Champion safety and regulatory compliance at all times.

Skills

Cleanroom operations

GMP compliance

Equipment operation

Process monitoring

Problem solving

Education

Bachelor's degree

Associate's degree + 6 months experience

High school diploma + 2 years experience

Tools

DeltaV

Bioreactors

Roller bottle systems

UF/DF

Sterile cleaning systems

Job description

Amgen is seeking an Associate Manufacturing professional to join the Thousand Oaks team. You will support preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate in Building 7.

You will work in cleanrooms and help set up critical equipment, ensuring smooth operations and adherence to GMP standards. You will participate in training, qualification activities, and continuous improvement initiatives while collaborating with cross-functional teams to deliver reliable