Operator II

About the role

Responsible for processing Customer product under their care, custody, and control, utilizing industrial sterilization modalities in a highly regulated FDA, ISO and GMP environment. Responsible for the safe operation of processing equipment in accordance with all (Federal and State) operating regulations and procedures. Reviews and adheres to Customer provided work instructions and processing documents. Places and retrieves sterile, test or biological sampling devices to monitor appropriate processing levels. Performs intermittent Team Leader duties including supervising the plant floor and employee training during assigned shift, and assuming lead position for day-to-day activities as needed. Engages and embraces in Continuous Improvement, Lean, Quality, and Safety Initiatives.

Responsibilities

• Protects Customer product by assuring proper processing and handling according to operating procedures, Customer, quality, regulatory and internal company specifications; reviews and completes all appropriate processing documentation.
• Places and retrieves dose verification devices.
• Loads/unloads product into processing rooms and/or vessels.
• Loads product onto pallets.
• Stages processed product in shipping storage area.
• Ensures production schedule is followed and maintains critical product flow through the facility by effectively coordinating daily tasks and personnel to meet production demands and prevent unplanned downtime.
• Maintains required Operator certification(s), knowledge and understanding associated with the processing modality for which they are certified.
• Understands the scheduling process and can make recommendations to scheduling adjustments as needed.
• Monitors processing operation, control systems and equipment functionality to ensure safety and Customer specifications are met.
• Responds to process and equipment alarm conditions while acting within operational and safety guidelines.
• Maintains a safe and clean working environment by monitoring environmental control systems and inspecting equipment for unsafe conditions and reporting to supervision as required; generates maintenance work orders for repairs; responds to process and equipment alarm conditions and acting within operational and safety guidelines; conducts area housekeeping on a daily basis.
• May participate in scheduled or unscheduled safety rounds.
• Performs intermittent Team Leader duties including supervising the plant floor and employee training during assigned shift, and assuming lead position for day-to-day activities as needed.
• Assists management in ensuring proper processing of Customer products, serving as backup, and performing lead duties as needed.
• Provides guidance and direction and assists in training activities.
• Collaborates with supervision to ensure completion and effectiveness of training requirements, performance objectives and goals.
• Contributes to a team effort by performing in accordance with all STERIS policies, Values, GMP, Lean principles and other directives; supports the