Manufacturing Associate I - Day Shift

Role Summary

Manufacturing Associate I - Day Shift performing and documenting daily manufacturing operations in a cGMP environment, operating biologics production equipment, and executing validation protocols. Reports to the Manufacturing Supervisor.

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 using SOPs; main documentation includes 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.
• Enter data 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, Web Based Training).
• Familiarity with cGMP in Biotech or Pharmaceutical operations a plus.

Skills

• Operative skills for maintaining cleanroom practices and equipment.
• Documentation and data entry proficiency.
• Ability to follow SOPs and regulatory requirements.

Education

• Not specified beyond qualifications above; applicable for preferred candidates with relevant degrees.

Additional Requirements

• May be required to wear PPE and clean room garments daily.
• Work in a cold, wet environment; stand/walk for long periods; frequent lifting up to 50 pounds; occasional travel for offsite meetings or training.
• Ability to work assigned shift (day or night) and multiple shifts including weekends as necessary.