Aseptic Filling Setup Operator - 1st Shift

Guerbet; Raleigh (NC); On-site; USD 30,000 - 39,000; Full time

Job summary

Guerbet is hiring a Filling Setup Operator for 1st shift in the Raleigh, NC area. The role involves preparing filling lines for sterile pharmaceutical products, ensuring GMP compliance, and maintaining strict aseptic conditions in a controlled environment.

The successful candidate will set up equipment, document batch records, and assist in deviations investigations while coordinating with maintenance and quality teams. Ongoing training and adherence to safety standards are emphasized.

Qualifications

• High School Diploma or GED 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 handling of sterile components.

Skills

Aseptic processing knowledge

GMP compliance

Documentation & recordkeeping

Basic computer skills

Hand tool handling

Education

High School Diploma or GED

Tools

Microsoft Office

Pallet jack operation

Cleanroom equipment handling

Job description

Guerbet is hiring a Filling Setup Operator for 1st shift in the Raleigh, NC area. The role involves preparing filling lines for sterile pharmaceutical products, ensuring GMP compliance, and maintaining strict aseptic conditions in a controlled environment.

The successful candidate will set up equipment, document batch records, and assist in deviations investigations while coordinating with maintenance and quality teams. Ongoing training and adherence to safety standards are emphasized.