Manufacturing Associate II PC 570

Miltenyi Biomedicine•San Jose, CA

8d•$28 - $33•Onsite

About The Position

This position is responsible for the manufacture of biologics (LV) under cGMP conditions. Staff must follow established procedures, execute batch production records using good documentation practices and adhere to gowning procedures required for work in a cleanroom environment. Supports training new hires, troubleshooting, preparation of controlled documentation, and other Manufacturing duties.

Requirements

Bachelor’s degree (B.S.) from a four-year college or university and at least 2 years of related experience.
Previous GMP experience is desired, as is good aseptic technique.
Able to work a Flexible schedule: Monday – Friday with occasional overtime on weekdays & weekends.

Responsibilities

Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.
Complete successful gowning aseptic processes qualification.
Follow batch record instruction and complete GMP documentation, review same for completeness and accuracy.
Draft Change Controls, Investigations and Deviations as required.
Contribute to the development, writing, and review of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
Responsible for the proper maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies.
Responsible for cleaning of equipment and work areas as required.
Insure and maintain inventory and restock supplies when needed.
Complete Purchase Order Requests.
Assist in troubleshooting processing issues, support investigation and establishing root cause and resolution/corrective action.
Follow manufacturing schedules, ensuring adequate supplies and equipment are available and released for use.
Participate in calibration and validation activities as needed.
Keep supervisor informed of issues.
Help train new staff as needed.