Off-Shift SPO Technician

Responsibilities

Complete Lyophilized (LYO) cabinet operations
Operate manual, automatic, and semi-automatic packaging equipment
Perform set-up, troubleshooting, and minor repairs of equipment as needed
Use computer systems to operate equipment where necessary
Run equipment for containers, stoppers, caps, and other packaging components; clear jams with minor adjustments and communicate issues to technicians/supervisors
Complete required log sheets, batch records (including two-person reviews, sampling, and accountability calculations), training rosters, and other documentation with Right First Time (RFT) accountability
Enter and manage data in departmental systems/databases and complete timely, accurate SAP transactions (Q.E., PCL entries, start/end batches, etc.)
Conduct in-process testing/monitoring via paper/electronic systems (dose/seal checks, leak checks, broken glass checks, standards/challenges, reconstitution, control charts, etc.)
Set up and operate steam and dry heat sterilizers, including computer interface operations
Assemble, wash, and clean equipment/components
Prepare LYO cabinets for operations (computer interface operations and manual cleaning)
Load/unload and operate LYO cabinets
Coordinate inventory management of supplies, components, and equipment to meet production schedules
Ensure materials are organized, stored, segregated, and staged for production
Set up, operate, and troubleshoot packaging equipment, making minor repairs as necessary
Education Requirements

High School Diploma or equivalent
Required Experience/Skills

Successful completion of SPO Operator – Level 2 Aptitude test
Equipment

Steam sterilization equipment; thaw baths; lyophilization cabinets; inspection/labeling/packaging and material handling tools/equipment

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