Production Worker Biological Products

Schedule:

Monday to Friday 6:45 am to 3:15 pm

The Bio Production Technician will manufacture core company products including, but not limited to, brain powder, tissue, complement, and other blood products. The role will follow written procedures throughout the manufacturing process, provide timely notice, and seek proper instruction to manage manufacturing issues. The Bio Production Technician will also prepare media, substances, solutions, and reagents and perform related duties as required.

The Bioproduction Technician is responsible for executing manufacturing processes in a controlled and regulated environment to support the production of biological products such as proteins, antibodies, vaccines, or other biotechnology-based materials. The role involves operating equipment, maintaining accurate documentation, and ensuring compliance with good safety standards.

• Responsible for equipment usage, monitoring, basic troubleshooting, and calibration per established standard operating procedures.
• Responsible for setting up systems and equipment along with disassemble and maintenance of multiple pieces of equipment.
• Prepares flow paths, connections and routing of process equipment and pathways needed for process flows.
• Perform upstream and/or downstream bioprocessing operations (e.g., cell culture, fermentation, purification).
• Perform sterile and aseptic processing of animal serums and plasmas used in therapeutic and diagnostic applications.
• Prepare and monitor media, buffers, and other process solutions according to batch records
• Monitor critical process parameters and report deviations to supervisors.
• Operate and monitor biomanufacturing equipment including centrifuges, filtration systems, and lyophilizers.
• Execute process steps including fractionation, precipitation, purification, lyophilization
• Conduct in-process sampling and documentation for quality control and regulatory compliance.
• Follow standard operating procedures (SOPs), batch records, and good documentation practices meticulously.
• Clean, sanitize, and maintain production areas and equipment in accordance with cleanroom and biosafety standards.
• Maintains equipment standards to include calibration of equipment and coordinates with supervision for equipment maintenance and reliability programs.
• Participate in continuous improvement initiatives and troubleshooting efforts.
• Support inventory management and materials handling within the production area.
• Work collaboratively with Quality Assurance, Engineering, and R&D teams when needed.
• Assist in equipment calibration, troubleshooting, and process validation.
• Maintain accurate and detailed production logs and deviation reports.
• Comply with all safety, hygiene, PPE and biosafety procedures related to biological materials handling Work and participate in a team environment where shared responsibilities, problem solving, achieving team goals, and continuous improvements of the production process are basic expectations.
• Ensure all finished products are meticulously inspected for labeling or package defects.
• Understand and promote the quality system as a part of the Company's overall goal toward continual improvement through strict adherence to all company policies and procedures, as well as actively supporting and upholding the principles and values of the company.
• Comply with Pel-Freez, United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), ISO, Occupational Safety and Health Administration policies and procedures, food safety standards, general safety, animal welfare, quality, and good manufacturing practices.
• Exhibit exemplary attendance and punctuality.
• Perform other duties as assigned.

Based on the essential duties listed above, this position is considered safety-sensitive and therefore all work must be performed following quality standards and established safety procedures.

• A high school diploma or equivalent GED is required.
• Previous related experience preferred.
• Some college coursework in science is preferred.

• Knowledge and understanding of safety procedures and industry regulations and guidelines required by the Occupational Safety and Health Administration (OSHA), United States Department of Agriculture (USDA), and Food Safety and Inspection Service (FSIS).
• Basic understanding of planning and higher-level operational objectives.
• Familiarity with biological production is preferred.
• A…