Manufacturing Associate I PC 365

Miltenyi Biotec•Gaithersburg, MD

About The Position

This position manufactures biologics (LV) under current Good Manufacturing Practice (cGMP) conditions. The employee follows established procedures, completes batch production records using good documentation practices, and adheres to gowning requirements for work in a cleanroom environment. The role includes working in a temperature-controlled, sanitized laboratory setting. Employees routinely use standard medical and research equipment and are frequently exposed to cultured human cells and lentivirus-derived vector particles. Appropriate clothing and protective equipment must be worn when entering and leaving the laboratory. The work environment generally has moderate noise.

Requirements

High school diploma.
0–1 years of experience.
Ability to handle more than one task at a time and work at a rapid pace while maintaining attention to detail.
Ability to meet the physical demands of the role, including regularly walking; using hands to finger, handle, or feel; reaching, talking, and hearing; standing; climbing or balancing; stooping, kneeling, and crouching; and occasionally lifting or moving up to 50 pounds.
Vision abilities including close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Responsibilities

Follow cleanroom Standard Operating Procedures for gowning, traffic flows, and modes of operation.
Complete aseptic gowning-process qualification successfully.
Follow batch-record instructions and complete GMP documentation.
Use production equipment properly in accordance with cGMP requirements, SOPs, and safety policies.
Clean equipment and work areas as required.
Assist with revising and reviewing established documentation, including SOPs and BPRs.
Maintain inventory and restock supplies when needed.
Complete purchase order requests.