Operator, Aseptic Filling (Night Shift)

Role Summary

Operator, Aseptic Filling (Night Shift) supporting startup activities for a new parenteral manufacturing site, then operating and maintaining continuous production to ensure safe, quality medicines meet capacity plans. Role involves aseptic filling, formulation, barrier filling, visual inspection, and cross-functional collaboration with a focus on safety and quality. Opportunity for growth into leadership and technical roles at a growing site.

Responsibilities

• Support startup activities required to bring the area into service, potentially including formulation, aseptic isolator barrier filling, and visual inspection.
• After project completion, operate the process, troubleshoot, and collaborate cross-functionally to sustain continuous supply while upholding safety and quality standards.
• Run the manufacturing process to meet production schedules and assist in checking execution documentation (Electronic Batch Records, SAP, Cleaning Logs).
• Provide technical leadership on the shop floor, administer technical training, and train operators to perform tasks.
• Develop and maintain area operational procedures, quality controls, and ensure adherence to CGMPs and quality systems.

Qualifications

• Required: High School Diploma or GED
• Required: Valid driver’s license
• Required: Pass a “fitness for duty” physical exam
• Required: Legally authorized to work in the United States (no visa sponsorship anticipated)
• Required: Vision tests confirming normal or corrected-to-normal vision and color vision requirements; ability to work a 2-2-3 schedule

Skills

• Ability to communicate effectively (electronic, written, and verbal)
• Lead and train team members; troubleshoot and triage challenges
• Computer proficiency (desktop software, MS Office)
• Knowledge of CGMPs and Manufacturing Execution Systems
• Experience in operations or manufacturing environments; ability to work in a cleanroom environment (Grade C, ISO 8)
• Continuous improvement mindset (Lean, Six Sigma familiarity)
• Ability to wear PPE and operate highly automated, semi-automated, or manual equipment

Education

• High School Diploma or GED