Bio-manufacturing Operator I (500AM-200PM)

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

Associates 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.