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 required
Skills 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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