Operator, Aseptic Filling (Night Shift)

Role Summary

Operator, Aseptic Filling (Night Shift) responsible for supporting startup activities during project phase and, post-startup, for reliably running aseptic filling operations, troubleshooting, and cross-functional collaboration to ensure continuous supply of medicines. Opportunities for growth into leadership and technical roles exist as the site expands.

Responsibilities

• Support startup activities required to bring the Parenteral (PAR) area into service, including formulation, aseptic isolator barrier filling, and visual inspection.
• Become the expert in assigned area and educate the team on proper operation of the facility.
• After project phase, expertly run the process, troubleshoot, and collaborate cross-functionally to maintain safety and quality while meeting production capacity plans.
• Lead on manufacturing floor to ensure safety, quality, and productivity; mentor others and maintain compliant operations.
• Administer technical training and ensure operators are trained to perform tasks; assist in documenting execution (e.g., Electronic Batch Records, SAP, Cleaning Logs).

Qualifications

• Required: High School Diploma or GED
• Required: Valid driver's license
• Required: Pass a fitness-for-duty physical; pass a vision exam with 20/20-equivalent near vision; color vision sufficient for job tasks
• Required: Legal authorization to work in the United States (sponsorship not anticipated)
• Required: Ability to work a 2-2-3 schedule

Preferred

• STEM degree or certifications
• Aseptic filling, single-use assemblies, isolator technology experience
• Experience with CGMPs and in pharmaceutical, medical device, or related manufacturing environments
• Experience with Manufacturing Execution Systems and electronic batch release; SAP
• Lean, Six Sigma, continuous improvement experience

Skills

• Strong problem-solving and troubleshooting abilities
• Effective communication (electronic, written, and verbal)
• Ability to train and educate team members; leadership capability
• Adaptability to troubleshoot and triage challenges; flexible scheduling
• Proficiency with desktop software (MS Office)

Education

• High School Diploma or GED