Senior Biologics GMP Manufacturing Associate - Swing Shift

Miltenyi Biotec, Inc.; San Jose (CA); On-site; USD 67,000 - 78,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Miltenyi Biotec, Inc. in San Jose, CA is seeking a Senior Manufacturing Associate I for swing shift (1:00 pm - 9:30 pm) to manufacture biologics under cGMP conditions. You will follow SOPs, complete batch records, maintain cleanroom practices and support equipment readiness.

The role involves assisting with investigations, developing SOPs, and maintaining accurate GMP documentation while ensuring inventory and safety compliance. On-site, full-time position with competitive benefits.

Qualifications

• High School diploma or equivalent; 2+ years related experience.
• Previous GMP and aseptic technique experience is desired.

Responsibilities

• Adhere to clean room SOPs for gowning, traffic flows and modes of operation.
• Support manufacturing schedules; ensure equipment availability and material supply.
• Execute batch records; complete GMP documentation and review records for accuracy.
• Assist Manufacturing leads in investigations and corrective actions as required.
• Contribute to development and review of SOPs, MSs, SMPs and BPRs.
• Responsible for cleaning and maintenance of production equipment in accordance with cGMPs and safety policies.
• Maintain inventory and restock supplies; assist in troubleshooting processing issues and root-cause analysis.
• Collect, trend, and analyze process data using MS Excel.
• Swing Shift Schedule: 1:00 pm to 9:30 pm, Monday thru Friday

Skills

Articulate production equipment issues

Cross-department communication

Computer literacy

Quality & safety mindset

Job description

Miltenyi Biotec, Inc. in San Jose, CA is seeking a Senior Manufacturing Associate I for swing shift (1:00 pm - 9:30 pm) to manufacture biologics under cGMP conditions. You will follow SOPs, complete batch records, maintain cleanroom practices and support equipment readiness.

The role involves assisting with investigations, developing SOPs, and maintaining accurate GMP documentation while ensuring inventory and safety compliance. On-site, full-time position with competitive benefits.