Asepsis, Automated Assembly Equipment, Biotech and Pharmaceutical, Cleanroom, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High School Diploma, ISO (International Organization for Standardization), Manual Dexterity, Manufacturing, Manufacturing Equipment Maintenance, Microsoft Office, OSHA, Problem Solving Skills, Process Improvement, Quality Metrics, Regulatory Compliance, SAP, Safety Standards, Safety/Work Safety, Standard Operating Procedures (SOP), Team Building, Team Player
The Pharmaceutical Packaging Operator is responsible for operating high-speed packaging lines in compliance with SOPs, cGMPs, and safety standards.
They ensure product quality, accurate documentation, and efficient line performance while supporting team goals and continuous improvement.
- Operate and monitor manual/automated equipment for assembly, filling, labeling, and packaging.
- Perform line set-ups, changeovers, and clearances per SOPs and GMPs.
- Conduct in-process inspections, verify components, and reconcile product counts.
- Maintain cleanrooms and equipment following cGMP and 5S standards.
- Complete batch records, logbooks, and documentation accurately.
- Accept/reject products based on quality standards.
- Collaborate with maintenance and team members to resolve issues and improve processes.
- Participate in training, meetings, and team development activities.
Regulatory compliance includes adherence to FDA, ISO 13485, OSHA, and other standards, with support for environmental and safety initiatives.
Requirements include a high school diploma, 1+ year manufacturing experience (preferably pharma), familiarity with GMP and aseptic production, and basic Microsoft Office and SAP skills.
Skills needed are strong attention to detail, communication, manual dexterity, and physical ability to lift, stand, and work any shift.
Time is allocated approximately as 50% equipment operation, 30% documentation, and 20% teamwork and process improvement.
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Katalyst Healthcares & Life Sciences