Blister Filling Line Operator
2 months ago
Overview:
Operator on a primary filling/blistering line. Responsibilities include, completing and reviewing related BFL paperwork, Operating the equipment, performing basic maintenance tasks like PMs and set-ups, maintain necessary supply levels of materials needed for BFL operation, assisting with the coordination of cleans. Maintaining certification in the area(s) you are running. Work with all supervision and employees to ensure that cGMPs, and Praxis SOPs, policies and work instructions are being followed. Complete batch related documentation in a careful, legible manner with minimal errors. Determine batch yield and reconcile all components as part of batch record completion.
Responsibilities:- Know and accurately complete all paperwork (ex: batch record, PLCL, CPO, Clean-up, Start-up, Log book, Rate Sheets, Skid Tickets, MFG Board, etc.).
- Operate BTL primary and secondary equipment
- Troubleshooting all regular equipment faults
- Performing basic maintenance including but not limited to Preventive maintenance, Change overs and Setups.
- Review completed batch records for accuracy and completeness, as needed.
- Check all products and components with each job on the line for accuracy and record required product and component information in the batch record.
- Check the quality of the product and call for Quality Assurance when needed.
- Adjust operations as necessary to achieve quality and efficiency goals for the line.
- Perform minor adjustments on machines (i.e. label, and tape changes).
- Challenges vision systems.
- Make sure the line is cleared per the proper line clearance procedure and cleaned between jobs and at the end of the shift.
- Communicate any problems or concerns with the Shift Supervisor.
- Tag and remove skids from the line.
- Have sufficient amount of product and components on the line to allow for a steady flow of work.
- Comply with all safety, quality, and GMP practices.
- Coordinate room cleans with personnel, ensure clean is conducted correctly and timely.
- Assist in the monitoring of acceptable levels of necessary BFL related materials and supplies.
- Assist in ensuring smooth and efficient line changeover, which may occur during the shift, engaging Maintenance when required.
- Ensure maintenance issues are communicated and resolved promptly.
- High school diploma or equivalent required, Associates Degree or equivalent combination preferred
- 2-4 years similar experience required.
- Lead/Group Leader experience preferred.
- Basic Mechanical and mathematical aptitude required.
- Ability to comprehend and follow written English instruction and specifications, required.
- Ability to speak, read and write English in a manner that is sufficient for effective communication with supervisors, employees, and customers to include reading and writing skills to understand and complete necessary customer paperwork, required.
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