Production Operator

Kindeva is passionate about helping you realize the full potential of your career. We have the vision to see what’s possible, the expertise to make it happen and the agility to overcome any challenge along the way.  Together, as One Team, we will manufacture many more tomorrows. We are a hiring TDD Production Operators to join our team! We are hiring for all shifts.  Please apply with as much open availability as possible!   ROLE SUMMARY Responsible for the setup, operation of Converting and packaging equipment that produces Transdermal Pharmaceutical drugs. 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. The Converting Technician may also be responsible for operator activities within the production area as needed. Must be able to perform the essential functions of the job, as listed in the Essential Function Analysis Form, with or without a reasonable accommodation. 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 thorough and accurate line clean checks to ensure there is no risks of product cross contamination as required. 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. Maintains and ensures Converting and Packaging area is clean and orderly and reports any property damages to Supervisor immediately. Knows and uses good safety work practices during the scheduled work shift. Takes ownership for ensuring the Converting and Packager are running a safe operational state, promptly communicates all unsafe conditions in the Converting department to Supervision and Management.Identifies opportunities for improving safety and actively participates in safety programs. Operates all material handling equipment in safe manner and follows all safety plant safety requirements for material handling equipment. Anticipates and plans for lot kitting, staging, Converting and Packaging operations for the efficient transition to the next lot. 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. Takes leadership and ensures that co-workers also follow PPE requirements. When required, may be asked to cover for and/or relieve other Converting technicians and at times work as a production operator. Performs material handling operations as required. Provides leadership with the production operators. Works with Maintenance to resolve equipment issues and any production related interruptions. Operates manual and electric pallets jacks and is required to operate a fork lift in a safe manner under the plant safety guidelines. Functions as the SME technician for training of new technicians for all required Converting and Packaging equipment processes. 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. May be required to temporarily change shifts, work mandatory overtime or to help in other areas in TDD or in the plant. Attends and Participates in required production meetings. Takes the initiative to help when required or needed within the total production operation Works in other areas of the department at the discretion of the supervisor. Hazardous Waste Duties including handling or generating hazardous waste and preparing hazardous waste for shipment and/or loading hazardous waste onto transport units BASIC QUALIFICATIONS Excellent attention to details is essential Must be able to follow written and verbal instructions; able to read, write legibly, understand, and communicate in English Must become certified in job performance within the specified amount of time allowed, this also applies to yearly re-certification requirements. Uses a calculator and has good basic math skills including metric conversions and percentages Report all labor activities accurately into computerized labor reporting system. Excellent teamwork & interpersonal skills, able to effectively communicate process and equipment information to co-workers and FOT management Must be proficient in the operation of all Converting and Packaging equipment 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   #LI-Onsite