Process Mechanic
LTS Nasal and Sterile Drug Products · Lakewood, NJ · 3 wk ago
On-siteManagementFull-time
Responsibilities
- 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
- On-going preventative maintenance of machinery or equipment
- 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
- Make effective decisions and take action based on deductive reasoning and potential product impact
- Identify improvement opportunities in given processes / procedures
Qualifications
- Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines
- Must be able to gown to work in a clean room environment and maintain gowning status
- Possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means
- Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems