Senior Manufacturing Associate I (Swing Shift - 1pm - 9:30pm) PC 567

Miltenyi Biotec•San Jose, CA

About The Position

This position is responsible for manufacturing biologics under cGMP conditions. The employee follows established procedures, executes batch production records using good documentation practices, and adheres to gowning procedures for cleanroom work. The role also supports training new hires, troubleshooting, preparation of controlled documentation, and other manufacturing duties. The position works in a sanitized, temperature-controlled laboratory setting and routinely uses standard medical and research equipment. Employees are frequently exposed to cultured human cells and lentivirus-derived vector particles and must wear appropriate clothing and protective equipment when entering or leaving the laboratory. The swing-shift schedule is 1:00 p.m. to 9:30 p.m., Monday through Friday.

Requirements

High school completion.
At least 2 years of related experience.
Ability to communicate production equipment and manufacturing process problems accurately and in detail, including to multiple departments.
Excellent computer, verbal communication, and written communication skills at all levels.
Quality and safety mindset.
Ability to learn quickly.
Ability to handle multiple tasks while working at a rapid pace and maintaining attention to detail.
Ability to meet the physical demands of the role, including occasionally lifting or moving up to 50 pounds.

Nice To Haves

Previous GMP experience.
Previous aseptic technique experience.

Responsibilities

Follow cleanroom SOPs for gowning, traffic flows, and modes of operation.
Support manufacturing and production schedules; ensure equipment is available and released for use, maintain materials supply, and perform process setup, operations, and monitoring.
Execute batch record instructions and SOPs, complete GMP documentation, and assist with reviewing executed batch records for completeness and accuracy.
Assist Manufacturing Team Leads with investigations and corrective actions.
Contribute to developing, writing, and reviewing SOPs, Material Specifications, Standard Manufacturing Procedures, Batch Production Records, and other GMP documentation.
Clean, maintain, and use production equipment in accordance with cGMPs, SOPs, and safety policies.
Maintain inventory and restock supplies as needed.
Troubleshoot processing issues, support investigations, and establish root cause and resolution or corrective action.
Collect, trend, and analyze process data using MS Excel.
Support training new hires and perform other manufacturing duties.