Under the direction of supervision (i.e. supervisor and/or team leader), the machine operator is responsible for tending, monitoring and/or performing operational tasks of assigned equipment and machinery to meet production schedules.
Assist and support the department trainer in training new operators and shall assist in troubleshooting problem product conditions• Perform machine operation of production equipment within multiple areas in addition to processing over-the-counter (OTC) products• Perform new product validations and provide mechanical support for Product Development pilots• Make recommendations to technical staff and leadership for new equipment, special projects and ergonomics• Perform minor repairs on equipment and machinery within parameters of work instructions• Serve as proxy for manufacturing team leaders as needed• Properly changeover, disassemble, clean, reassemble and operate all production related equipment in the assigned department in a safe and efficient manner• Operation of necessary machinery related to the job classification including documentation of the processing steps in the batch record and/or other necessary paperwork (i.e. initial setup, raw material usage, quality/weight checks and finished product quantity)• Setup, operating, adjusting programmable logic control (PLC) equipment for each batch formulation (minimum 10 or more daily)• Responsible for breaking-down, cleaning, tooling, setting up and preparing solution for (if required) equipment• Pull, deliver and stage all materials needed; Complete stock and raw/in-process/finished material transfers• Operate, monitor and troubleshooting equipment: hand tools, viscosity meters, pneumatic equipment, pressers, melters, manual hand joggers, coaters, blenders, technophars, turret lifts, dust removers, part washers, hoppers, mills and solution tanks• Utilize Mettler moisture analyzers to perform moisture checks on core products• Must adhere to work instructions to ensure a consistent material is generated per customer specifications are achieved in an safe, effective and efficient manner• Utilize company ERP system (AS400) for inventory transactions, scanning, label creation, verifying additions to batch records and data entry• Utilize Microsoft Office Suite (Word, Excel and Outlook) to log production outputs, create product start-up documents to record relative standard deviations (RSDs), friability, disintegration, reliability/quality testing)• May use (but not limited to) power equipment such as a forklift, hand tools, and other devices operated in a warehouse environment (i.e. electric jacks, sit down, stand ups, and cherry picker forklifts for applicable area(s))• Monitor and adjust machine parameters in specification to maintain finish product quality and ensure proper machine operation• Ensure that codes/lots and finished products are not mixed• Removal and reconciliation of excess and unused materials• Perform calibrations as necessary to keep all parameters in specification• Perform routine preventative maintenance: Routine clean-up during operation, quick clean between lots, and full clean when required• Other duties as assigned, overtime as requiredSkills and Abilities• Adherence to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) in effect, assuring the quality and quantity of product produced as required• Maintain clean work environment at all times, including and not limited to hygiene practices• Ensure proper labeling of finished product while completing all necessary paperwork / documentation as required (i.e batch records)• Know and understand the cGMP and other regulatory compliance• Ensure job specific safety procedures are established and followed• Maintain awareness and enforcement of health and safety practices and activities• Be involved in the development, implementation, and updating of health and safety plans and procedures• Actively participate in health and safety training programs and demonstrate competency based on training received• Make safety a priority in daily operations by:• Actively participating in health and safety activities,• Ensuring compliance with regulatory requirements,• Ensuring adequate resources are provided, and• Providing suggestions for improvement to the health and safety progra
High School diploma or equivalent• 1 year machine operation experience in a manufacturing environment• Capacity to perform basic computer transactions.• Ability to read and comprehend simple instructions, short correspondence, and memos in English. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to other employees of the organization.• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.• Ability to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations
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