Manufacturing Associate I - Night Shift

Role Summary

As a Manufacturing Associate I, you will perform and document daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment and will execute validation protocols. You will report to the Manufacturing Supervisor. This is a night shift role with a rotating schedule (5:45 PM to 6:15 AM).

Responsibilities

• Perform dispensing, labeling, and transferring/staging of raw materials and parts.
• Assemble/disassemble, clean, and sterilize components, parts, and equipment.
• Maintain equipment, area, and cleaning logbooks.
• Assemble and operate biologics production equipment (bioreactors, filtration units, chromatography systems, fixed/portable vessels) with general guidance.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities following SOPs, including batch records, work orders, and equipment logbooks.
• Assist with processing steps and manufacturing support activities by managing process parameters in batch records and control systems.
• Execute batch records and validation protocols under supervision.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Perform data entry into LIMS.
• Perform cleaning/sanitizing of production equipment.

Qualifications

• High school diploma or GED.
• Experience in GMP environment preferred.
• Associates degree or higher in a scientific discipline preferred.
• Understanding of cGMP and GDP preferred.
• Knowledge of QC, Regulatory, QA, and/or Materials Management a plus.
• Prior experience with lab equipment a plus.
• Knowledge of mathematical calculations and rounding.
• Basic computer operations (MS Office, email, training via Web Based Training).
• Familiarity with cGMP in Biotech or Pharmaceutical operations a plus.

Skills

• Ability to operate manufacturing equipment and interpret basic documentation.
• Attention to detail and accuracy in data entry and record-keeping.
• Problem-solving and basic troubleshooting capabilities.

Education

• High school diploma or GED required; an associates degree or higher in a scientific discipline preferred.

Additional Requirements

• May be required to wear PPE and clean room garments daily.
• Work in a cold, wet environment; stand/walk for long periods; lift up to 50 pounds; climb, bend, kneel, and perform overhead work as part of job duties.
• Ability to work assigned shift (including weekends) and travel to offsite meetings or training events on rare occasions.