Manufacturing Associate I - Night Shift

Role Summary

Manufacturing Associate I – Night Shift. Location: Brooklyn Park, MN. This role operates on a rotating night schedule from 5:45 PM to 6:15 AM and involves performing and documenting daily manufacturing operations in a cGMP environment, operating biologics production equipment, and executing validation protocols.

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 per 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 a GMP environment preferred.
• Associates degree or higher in a scientific discipline preferred.
• Understanding of cGMP and GDP preferred.
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, or Materials Management a plus.
• Prior experience with lab equipment a plus.
• Knowledge of basic mathematical calculations and rounding.
• Ability to perform basic computer operations (MS Office, email, Web Based Training).
• Familiarity with cGMP within Biotech or Pharmaceutical operations a plus.

Education

• High school diploma or GED.
• Associates degree or higher in a scientific discipline (preferred).

Skills

• Documenting data accurately in accordance with SOPs.
• Basic equipment operation and troubleshooting.
• Data entry and use of SAP and LIMS systems.

Additional Requirements

• May be required to wear PPE and clean room garments daily (safety shoes, safety glasses, aprons, face shields, lab coats, gowns, hair nets, gloves, hearing protection).
• Must remove makeup, jewelry, contact lenses, nail polish while in manufacturing environment.
• Work in a cold, wet environment; stand/walk for extended periods; lift up to 50 pounds; climb and bend as required; overhead reaching and repetitive arm/ wrist use.
• Work multiple shifts, including weekends; travel to offsite meetings or training on rare occasions.