Bio-Manufacturing Operator I

Bio-manufacturing Operator I

Job Code
MNFMT1

FLSA Status
Non-Exempt

Position Summary

Performs entry-level bio-manufacturing operations associated with fermentation, drying, and downstream processing of Bacillus and other spore-forming bacteria. Operates production equipment under supervision, follows SOPs and batch records, and maintains safety, quality, and documentation standards in a GMP manufacturing environment.

Key Responsibilities

• Assist with loading, setting up, and harvesting bioreactor tanks according to SOPs and batch records.

• Fill slurry product into trays and perform standard and/or cryo-freezing while ensuring proper labeling and traceability.

• Load frozen slurry product into storage freezers and transfer materials to downstream processing areas.

• Assist with loading and unloading freeze dryers and spray dryers under direction of senior operators or supervision.

• Weigh out raw materials and ingredients accurately in accordance with production formulas and instructions.

• Clean product trays, racks, addition cans, and equipment following approved sanitation procedures and chemical handling guidelines.

• Refill and set up addition cans and related equipment in a hygienic and safe manner.

• Assist with receiving and loading of goods, including raw materials, packaging, and supplies.

• Prepare finished product and materials for shipping, including labeling, palletizing, and staging.

• Operate basic plant equipment (e.g., scales, tray washer, pallet jack, forklift if certified) in a safe and efficient manner.

• Maintain accurate, legible, and timely production records, logs, and cleaning documentation.

• Follow all SOPs, work instructions, cGMP, HACCP, FSMA, OSHA, and site-specific safety procedures.

• Identify and promptly communicate safety, quality, equipment, or process issues to supervision.

• Contribute to maintaining a clean, organized, and audit-ready work environment.

Additional Responsibilities

• Participate in cross-training to build proficiency across fermentation and downstream areas.

• Support troubleshooting and continuous improvement initiatives related to safety, quality, and efficiency.

• Assist in training new or less experienced operators as knowledge and proficiency increase.

• Perform general area housekeeping, including waste handling and inventory organization.

• Perform other duties as assigned to support production schedules and business needs.

Work Environment

• Majority of work performed in a fermentation production facility with wet, humid, dusty, and noisy conditions.

• Exposure to processing equipment, moving mechanical parts, and sanitation chemicals.

• May be exposed to airborne particles and chemicals used in fermentation and cleaning processes.

• Work is primarily on-site; shift, weekend, and overtime work may be required based on production needs.

Minimum Qualifications

• High school diploma or equivalent.

• Ability to follow written SOPs, work instructions, and verbal directions with attention to detail.

• Basic math skills and ability to use a computer for data entry and production records.

• Ability to perform physically active work, including standing and walking for most of the shift and lifting up to 50 lbs.

• Ability to work safely with chemicals and cleaning agents while using required PPE.

• Ability to work effectively as part of a team and communicate clearly with coworkers and supervisors.

Preferred Qualifications

• Associate’s degree or higher in biotechnology, microbiology, chemistry, or a related technical field.

• 1 or more years of experience in fermentation, food production, biotech, pharmaceutical, or chemical manufacturing.

• Familiarity with cGMP, HACCP, FSMA, and basic quality systems.

• Experience operating fermentation, drying, or related processing equipment.

• Experience with basic material handling equipment, including forklifts and pallet jacks.

Technical Skills

• Basic understanding of manufacturing processes, particularly fermentation and/or downstream processing.

• Ability to operate scales, tray washers, freezers, and basic production equipment after training.

• Ability to complete production documentation accurately and in compliance with quality requirements.

Non-Technical Skills

• Strong attention to detail and commitment to safety and product quality.

• Reliable, punctual, and able to adapt to changing production priorities.

• Team-oriented with good interpersonal and communication skills.

• Willingness to learn new equipment, procedures, and technologies.

Licenses/Certifications

• Forklift certification preferred or ability to obtain certification upon hire.

• Other site-specific safety or equipment certifications as required.

Physical & Safety Requirements

• Ability to lift, carry, push, and pull up to 50 lbs. on a regular basis.

• Frequent standing, walking, bending, reaching, and occasional kneeling or crouching.

• Mandated use of company-issued uniform and appropriate Personal Protective Equipment (PPE).

• Adherence to all company safety procedures, including lockout/tagout and chemical handling guidelines.

Disclaimer

Adherence to all food safety procedures as per FDA regulations, including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal, state, or local food safety regulations.