Aseptic Filling Operator — 2nd Shift

Guerbet; Raleigh (NC); On-site; USD 36,000 - 54,000; Full time

Job summary

Guerbet, based in Raleigh, NC, seeks a Filling Operator to operate aseptic filling equipment and maintain product quality in a cGMP environment. You will monitor equipment, complete batch records, and ensure sanitation and sterility throughout the manufacturing process.

Requirements include a high school diploma and 1–2 years of pharmaceutical production experience; strong aseptic and cleanroom knowledge is essential; the role is 2nd shift with potential for growth within a global leader in

Qualifications

• High School diploma, GED, or equivalent required.
• 1-2 years’ experience as a Production 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

• Operate and monitor filling equipment to ensure efficient and accurate production.
• Monitor production equipment while in operation to ensure quality of product.
• Perform cleaning and sanitization of aseptic areas using approved disinfectants and techniques to maintain sterile conditions.
• Maintain strict adherence to aseptic techniques during all operations, including gowning, material transfer, and interventions with controlled environments.
• Understand and apply principles of sterility assurance, including proper handling of sterile components and monitoring of aseptic conditions.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.
• Accurately complete all documentation including but not limited to batch records, logbooks, and deviation reports in compliance with cGMP and data integrity requirements.
• Ensure a high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Promptly report and assist in investigation of any contamination events or deviations.
• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.
• Performs other duties as assigned by management
• Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
• Collaborate with Engineering, Validation, and other departments initiating and implementing programs such as Continuous Improvement (Lean and 5S) and Total Productive Maintenance.
• Cross-training to perform tasks and roles outside of the primary responsibilities.
• Performs other duties as assigned.

Skills

Aseptic processing

Cleanroom standards

Sterile techniques

Manual dexterity

Math aptitude

Communication skills

Education

High School diploma / GED

Tools

Microsoft Office

Hand tools

Job description

Guerbet, based in Raleigh, NC, seeks a Filling Operator to operate aseptic filling equipment and maintain product quality in a cGMP environment. You will monitor equipment, complete batch records, and ensure sanitation and sterility throughout the manufacturing process.

Requirements include a high school diploma and 1–2 years of pharmaceutical production experience; strong aseptic and cleanroom knowledge is essential; the role is 2nd shift with potential for growth within a global leader in