Job Title: Biologics Process Assistant

Work Location: McLennan County, Texas

Summary:

The Biologics Process Assistant plays a key role in converting raw materials into finished biologic products. This position involves the set-up, operation, and cleaning of process equipment, as well as handling and storage of blood-derived components in a regulated cleanroom environment.

Responsibilities:

• Assist with aseptic biologics processing by following established SOPs, Master Batch Records, and GMPs in an ISO 7 cleanroom environment.
• Operate and maintain manufacturing equipment such as centrifuges, biosafety cabinets, incubators, freezers, steam autoclaves, and ovens.
• Perform cleaning and sanitization of facilities, equipment, and tools, including autoclaving as required.
• Receive and properly store human blood-derived component units, ensuring material quality and compliance with procedures.
• Ensure plasma and blood-derived components are stored and handled according to SOPs, including management of unsuitable units and samples.
• Document all activities accurately and in compliance with SOPs, maintaining strong attention to detail and adherence to safety policies.
• Support continuous plant operations by being flexible with work hours and shifts, including exposure to dry ice and biological hazards.
• Maintain compliance with all safety, documentation, and operational protocols while working in a cleanroom for extended periods.

Qualifications:

• High school diploma or GED required; Associate’s degree or applicable certification preferred.
• Experience and knowledge in bio-aseptic techniques and cleanroom environments.
• Proactive, results-oriented, and detail-focused with a strong work ethic and sound judgment.
• Strict adherence to SOPs, safety policies, and documentation standards.
• Ability to read, write, and speak English fluently.
• Computer literacy, including proficiency in MS Office (Outlook, Word, Excel).
• Flexible availability to accommodate a 7-day plant operation schedule.
• Ability to lift/move up to 40 pounds, gown and work in an aseptic/cleanroom environment for up to five hours at a time, and perform tasks requiring manual dexterity.

Published Category: Manufacturing & Technical Operations