As part of the Integrated Process Team (IPT), the Production Operator performs a range of production and operational tasks within an empowered team environment. The role supports the manufacture and reliable supply of product while ensuring objectives are achieved in alignment with company requirements for compliance, safety, quality, and customer supply.
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Operate and/or monitor production activities and support equipment using MES, DCS, and PLC-based systems to ensure optimal equipment uptime and achievement of target outputs. Equipment may include, but is not limited to:
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Maintain a Right First Time (RFT) mindset in all production activities.
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Perform cleanroom cleaning, housekeeping, and materials management across production areas, with a focus on continuous process improvement using Lean principles.
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Achieve and maintain full certification and proficiency on all equipment, processes, and tasks within the assigned area.
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Understand factory priorities and schedules through RTMS and act proactively without direct supervision.
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Manage equipment flow, including:
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Tracking soiled and clean hold times
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Ensuring proper labeling
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Inventory management of clean and sterile equipment
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Using Kanban systems and automated MES to assign QC status and manage expiry of sterile equipment
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Perform routine maintenance, preventative maintenance tasks, troubleshooting, and minor repairs where qualified.
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Participate in writing, revising, and rolling out operational procedures and training materials; ensure adherence to approved documentation.
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Support continuous improvement initiatives by:
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Participating in investigations and report writing
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Supporting change control execution and development
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Contributing to Kaizen events and improvement projects
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Performing root cause analysis using tools such as FMEA, Fishbone diagrams, and 5 Whys
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Implementing corrective actions through the change management system
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Identify and escalate roadblocks or issues related to safety, quality, delivery, or personnel in a timely manner.
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Perform routine day-to-day problem-solving independently or as part of a team.
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Actively participate in Tier 1 meetings at the start and end of each shift, providing relevant updates and raising appropriate questions.
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Ensure compliance with global policies, procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP) in all daily activities.
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Take ownership of personal safety and adhere to all safety programs and procedures.
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Obtain and maintain all required safety certifications independently.
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Collaborate with colleagues to foster a safe and compliant operational culture.
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Perform additional duties as assigned.
