What are the responsibilities and job description for the Process Mechanic position at LTS Nasal and Sterile Drug Products?
This is a third-shift role with hours from 11:00 PM - 7:00 AM, Sunday - Thursday.
- Perform Line change over, set-up, start-up, including vision system training and data collection
- Identify parts needed for repairs using parts manual for specific equipment, and will assemble requisition for supervisor to order parts.
- Responsible for on-going preventative maintenance of machinery or equipment
- Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines.
- Maintain, repair and troubleshoot electronics on all production equipment on the sterile filling and packaging lines to minimize production downtime.
- Use computer and logic controllers to perform system analysis of equipment.
- Troubleshoot and repairs logic controls/PLC, steam regulators, steam traps, steam strainers, steam valves, temperature control loops associated with autoclaves, tunnels, ovens.
- Troubleshoot vision systems and automated weight checkers
- Fabricate and install simple control systems to enhance line performance.
- Perform changeover of packaging line equipment from one size and product to another accurately documenting the activities in accordance with procedures.
- Lead/Support small to medium sized process improvement projects to improve quality, safety and efficiency.
- Shift flexibility per business needs, and willingness to work overtime
- Demonstrated ability to be flexible and open to change, self-directed, motivated, and task oriented
- Make effective decisions and take action based on deductive reasoning and potential product impact.
- Identify improvement opportunities in given processes / procedures
- Possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means.
- Must be able to gown to work in a clean room environment and maintain gowning status
- Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.