2nd Shift Filling Setup Operator — GMP/Aseptic

Guerbet; Raleigh (NC); Hybrid; USD 52,000 - 66,000; Full time

Job summary

Guerbet is seeking a Filling Setup Operator to prepare manufacturing equipment for pharmaceutical products in an aseptic environment, ensuring quality and safety on every batch.

The role requires SOP and GMP adherence, documentation, and environmental monitoring, with a 2nd shift schedule (Mon-Thu, 3:00pm–1:30am) and OT as needed. Join Guerbet to contribute to life-improving imaging solutions globally.

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 elevate 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 aseptic techniques during gowning, material transfer, and interventions in clean rooms.
• Understand and apply cGMP and FDA/EMA guidelines in an aseptic environment.
• Accurately complete batch records, logbooks, and deviation reports in compliance with cGMP and data integrity.

Skills

Filling equipment setup

Equipment disassembly

Troubleshooting

Autoclave operation

Aseptic techniques

Gowning procedures

cGMP compliance

Documentation

Environmental monitoring

Microsoft Office

Hand tools

Education

High School Diploma or GED

Tools

Autoclave equipment

Job description

Guerbet is seeking a Filling Setup Operator to prepare manufacturing equipment for pharmaceutical products in an aseptic environment, ensuring quality and safety on every batch.

The role requires SOP and GMP adherence, documentation, and environmental monitoring, with a 2nd shift schedule (Mon-Thu, 3:00pm–1:30am) and OT as needed. Join Guerbet to contribute to life-improving imaging solutions globally.