High School Diploma or GED with 4+ years of experience in a cGMP manufacturing environment; OR Associate degree in Life Sciences, Engineering, or a related technical discipline with 2+ years of cGMP manufacturing experience; OR Bachelor's degree in Life Sciences, Engineering, or a related technical discipline; OR equivalent military training or experience.
Experience supporting purification, chromatography, filtration, recovery, or other downstream manufacturing operations.
Experience working within a GMP-regulated biologics, biotechnology, or pharmaceutical manufacturing environment.
Familiarity with automated manufacturing control systems and electronic batch records.
Experience operating AKTA systems, chromatography skids, tangential flow filtration (TFF) systems, depth filtration equipment, or other downstream processing equipment.
BioWork certification.
Ability to stand for extended periods while performing manufacturing tasks.
Ability to perform repetitive tasks using hands, wrists, and fingers for equipment operation and documentation.
Ability to bend, push, pull, reach, and lift materials up to 33 pounds as part of routine manufacturing activities.
Ability to ascend and descend ladders and access manufacturing equipment safely.
Ability to work in manufacturing environments requiring personal protective equipment, including respiratory protection when necessary.
Ability to work in temperature-variable manufacturing environments.
Knowledge of cGMP regulations and safety requirements applicable to biopharmaceutical manufacturing operations.
Comfort using manufacturing systems and process control platforms such as DCS and MES.
Capability to perform cleaning and sanitization activities, including CIP and SIP processes.
Hands-on experience with purification, chromatography, and filtration processes in a manufacturing setting.