1st Shift Sterile Fill Operator – GMP

Aerotek; Kentucky; On-site; USD 25,000 - 33,000; Full time

Job summary

Aerotek is hiring for a 1st Shift Fill Operator to support sterile pharmaceutical manufacturing in a regulated cleanroom. Responsibilities include GMP-compliant batch preparation, compounding, and filling, with meticulous documentation and adherence to SOPs.

The role requires handling of materials and operation of computerized equipment, with PPE and gowning in place to maintain a controlled environment and product quality.

Qualifications

• Must have GMP manufacturing experience in a regulated environment.
• Experience with batch mixing, compounding, or following recipes and batch records.
• Strong documentation skills for GMP and batch records.
• Proficiency using computer systems for documentation, training, and SOP access.
• Ability to work in a cleanroom or highly regulated manufacturing environment.
• Must lift up to 40 pounds repeatedly.
• Must be able to stand and walk throughout shift.
• Comfort with gowning, respirators, and full PPE in FDA-regulated conditions.

Responsibilities

• Perform daily cleaning and sanitization of production equipment and areas.
• Complete GMP batch records and documentation accurately.
• Batch compounding and mixing of sterile products following procedures.
• Operate formulation systems and HMIs to support production.
• Assemble production components and prepare lines for runs.
• Conduct filter integrity testing and flushing procedures.
• Follow SOPs for material handling and production processes.
• Work in sterile cleanroom environments with required PPE.
• Access SOPs and training modules via computer systems and document management.
• Meet output targets while maintaining quality and safety.
• Visually inspect products and components for defects.
• Assist with packaging, labeling, and quality inspection.

Education

High school diploma or GED

Tools

HMIs

Computerized equipment

Job description

Aerotek is hiring for a 1st Shift Fill Operator to support sterile pharmaceutical manufacturing in a regulated cleanroom. Responsibilities include GMP-compliant batch preparation, compounding, and filling, with meticulous documentation and adherence to SOPs.

The role requires handling of materials and operation of computerized equipment, with PPE and gowning in place to maintain a controlled environment and product quality.