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Pharmaceutical Manufacturing Technician
1 month ago
Responsible for the setup, operation of Converting and packaging equipment that produces Transdermal Pharmaceutical drugs.
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity
The converting technician is responsible for effectively utilizing their skills to produce a product that meets established GMP quality standards.
In addition, the converting technician is expected to accomplish this by following and executing the Manufacturing Order instructions and Plant SOPs.
The converting technician is also responsible for ensuring the Converting and Packaging equipment is operated within established process parameters, and any additional implemented methods that apply.
ROLE RESPONSIBILITIES
· Operates Converting and Packaging equipment and ensures correct components are used in the correct amounts per manufacturing order requirements for all products being manufactured.
· Performs Converting and Packaging equipment parts installations, change-over and set-up operations in a timely, efficient, safe, accurate and compliant manner.
· Performs daily routine frequent line monitoring of the entire Converter and Packager and insures Converting and Packaging equipment are operating under established operating parameters. Any equipment observed as running outside of the established parameters must be reported to the supervisor and Process Engineer immediately.
· Ensures all products manufactured and packaged by the Converter and Packager meets GMP manufacturing specifications. Any deviations from the GMP requirement must be reported to the Supervisor and Process Engineer immediately.
· Performs proper and accurate materials verification timely as required in the SOP and ensures all raw materials used are cleared for usage when needed.
· Follows all cleaning procedures outlined in department SOP`s, manufacturing orders and PROTOCOLS for the Converting and Packaging equipment used in the manufacture of product Rollstock. Reports all or any discrepancies to Supervisor and Process Engineer immediately when discovered.
· Follows all safety procedures outlined in the EHS SOP for proper machine guarding and Lock Out Tag Out requirements. Reports any safety equipment failures to supervisor or EHS Engineer immediately.
· Able to trouble-shoot routine equipment problems and recognizes when supervision and maintenance should be notified which contributes to the plant goal of minimizing equipment down time per established OEE targets.
· Keeps Converting equipment running efficiently and per the production plan; immediately communicates with Supervisor and process engineers any issues that prevent equipment from running as scheduled.
· Communicates current production activities, schedule changes and equipment status changes of Converting with technicians on all shifts.
· Solid understanding and knowledge of in-process product quality requirements.
· Ensures all products Converted and Packaged are defect free from all contaminants. All defects found must be reported to supervisor and process engineer immediately.
· Accurately records process and lot information on Production Orders, manufacturing orders, PROTOCOLS, log books, labels, etc, in accordance with SOP, M.O. and cGMP requirements
· Always wears appropriate personal protective equipment (PPE) per EHS requirements when handling drug products and solvents during the Converting and Packaging processes.
· Operates manual and electric pallets jacks and is required to operate a fork lift in a safe manner under the plant safety guidelines.
· Expected to participate in Factory Experiments and Designs of Experiment as required by the Supervisor or Converting Process Engineer. This includes any applicable documentation: written summaries, graphs, test parameters, PM`s, etc.
· Hazardous Waste Duties including handling or generating hazardous waste and preparing hazardous waste for shipment and/or loading hazardous waste onto transport units
PHYSICAL QUALIFICATIONS
Physical effort involves lifting 25-65 lbs (latter on occasion); push/pull weight of approximately 30-60 lbs utilizing a dolly lifting assisted devices