Aseptic Filling Operator - 1st Shift (GMP/Cleanroom)

Guerbet; Raleigh (NC); On-site; USD 65,000 - 87,000; Full time

Job summary

Guerbet is seeking a Filling Setup Operator to prepare manufacturing equipment for producing pharmaceutical products in an aseptic environment. You will monitor batches, ensure quality and safety, and complete all required documentation in compliance with cGMP and GDP guidelines.

The role requires setting up equipment, operating autoclaves, and maintaining aseptic conditions. This is a 1st shift position: Mon-Thurs, 5:00 AM to 3:30 PM, located at our Raleigh facility with growth opportunities.

Qualifications

• High School Diploma, GED, or equivalent required.
• 2-5 years’ experience as a Production Set-Up Operator in a pharmaceutical manufacturing environment preferred.
• Knowledge of basic computer skills and Microsoft Office.
• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.
• Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.

Responsibilities

• Set up and configure filling equipment for specific products, ensuring proper calibration and compliance with SOPs and GMP standards.
• Disassemble the filling equipment as necessary.
• Troubleshoot minor mechanical issues and escalate complex problems to maintenance as needed to ensure smooth operations.
• Operate autoclave equipment for sterilization and filling processes.
• Monitor and adjust filling equipment to ensure efficient and accurate production.
• Perform environmental monitoring and in-process checks to ensure regulatory compliance.
• Perform cleaning and sanitization of clean room areas using approved disinfectants and aseptic techniques.
• Maintain strict adherence to aseptic techniques during all operations, including gowning and material transfer.
• Understand and apply principles of sterility assurance and monitoring of aseptic conditions.
• Demonstrate understanding of cGMP and regulatory guidelines in an aseptic environment.
• Accurately complete batch records, logbooks, and deviation reports in line with cGMP and data integrity.

Skills

Filling equipment setup

GMP compliance

Aseptic processing

Documentation accuracy

Equipment troubleshooting

Sterile techniques

Quality monitoring

Education

High School Diploma or GED

Tools

Autoclave operation

Pallet jack

Environmental monitoring tools

Job description

Guerbet is seeking a Filling Setup Operator to prepare manufacturing equipment for producing pharmaceutical products in an aseptic environment. You will monitor batches, ensure quality and safety, and complete all required documentation in compliance with cGMP and GDP guidelines.

The role requires setting up equipment, operating autoclaves, and maintaining aseptic conditions. This is a 1st shift position: Mon-Thurs, 5:00 AM to 3:30 PM, located at our Raleigh facility with growth opportunities.