Manufacturing Technician - Purification & GMP Ops

BioSpace; Thousand Oaks (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Amgen Thousand Oaks Drug Substance plant is seeking a Manufacturing Associate to support development, clinical and commercial launch activities. Under general supervision, you will perform operations in the manufacturing area following SOPs and GMP requirements.

You will set up, clean, monitor processes, draft documents, and participate on cross-functional teams. Base qualifications include a Bachelor’s or an Associate with experience, or a high school diploma with relevant experience; shift

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• Alternative: Associate degree with 6 months of manufacturing/operations experience.
• Or high school diploma/GED with 2 years of manufacturing/operations experience.

Responsibilities

• Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures.
• Perform and monitor critical processes.
• Complete routine validation protocols.
• Follow GMPs.
• Draft and revise routine documents (e.g. MPs, SOPs, reports).
• Initiate Quality incidents.
• Identify and implement improvements after approval.
• May train staff or act as safety representative.
• Work shift rotations (12-hour days/nights) for 24/7 manufacturing.

Skills

Hands-on operations

GMP knowledge

Troubleshooting

Quality incident handling

Cross-functional collaboration

Technical writing

Process monitoring

Education

Bachelor's degree

Associate degree + 6 months experience

High school diploma/GED + 2 years experience

Tools

LIMS access

DeltaV / Automation

Job description

Amgen Thousand Oaks Drug Substance plant is seeking a Manufacturing Associate to support development, clinical and commercial launch activities. Under general supervision, you will perform operations in the manufacturing area following SOPs and GMP requirements.

You will set up, clean, monitor processes, draft documents, and participate on cross-functional teams. Base qualifications include a Bachelor’s or an Associate with experience, or a high school diploma with relevant experience; shift