Manufacturing Specialist
ICU Medical, Inc.

Job Description

Position Summary

Coordinates area activities to include job assignments (rotation schedules) for the production and/or equipment operators, general housekeeping activities, compliance to all SOP, cGMP and safety policies and practices. Must respond to, monitor and record all mechanical downtime, participate in routine maintenance activities, account for all commodities allocated to the work order, perform a comprehensive review of all data entered, and assure a timely and accurate completion of the batch record, for submission to MQA.

Reports to: Dennis Rios

Dept: 1268 / PF Overwrap

Shift: 2Z - 6p - 6a

Essential Duties & Responsibilities:

• Organizes and assists in lot changes, performs line clearances, performs and documents cleaning operations, parameters, label copy verifications, "use" and "cleaning" log books, and daily room checklists. Inputs data onto work order and/or computer as needed.
• Prepares, set-ups, runs and monitors area equipment. Operates electrical, mechanical and air components, performs periodic checks on quality of product, trouble shooting and resolving machine problems as needed. Monitors and analyzes statistical process control. Ensures all area operations and employees' tasks are performed in compliance with cGMP's.
• Works directly with the supervisor and the area employees to ensure/maintain an orderly, safe and clean work environment. Ensures employees have the necessary/required tools, supplies, materials, components to perform their assigned tasks. Plans and makes routine decisions regarding the conduct of the operation. Follows up on all operational tasks. Reports all accidents immediately to the area supervisor. Ensures safety glasses, hearing protections and and/all PPE (personal protective equipment) is used as required.
• Participates in the equipment set up, changeovers and preventative maintenance. Communicates and supports the established labor and scrap standards for the respective tasks. Accurately completes the batch record, including all calculations.
• Works with both internal and external customers at all levels of the organization. Shares information, provides feedback to area supervisor and support functions on how the operation and machinery are running.
• Must be able to coordinate multiple activities at a time and make effective, timely assessments of operational needs.
• Communicates between shifts and support teams. Sets the example, consistent with Company policies and practices so that others may learn and follow. Is positive and receptive to change. Assists in the training of new employees. Anticipates operational and personnel problems and acts to minimize potential negative impact. Assists and supports area improvements, cost reductions, department changes and meetings.
• Adhere to cGMP guidelines, SOP's and plant policies/rules.
• Adjusts employees' work schedules to compensate for unexpected operational changes and keeps employees and support area informed regarding routine operational matters.
• Acts as liaison between mechanics and production operators to minimize mechanical issues.
• Efficiently handles production overflow, while ensuring all employees perform their work within established cGMP, safety, SOP and housekeeping guidelines.
• Perform other related duties as assigned or required.

Knowledge & Skills

• Must be able to demonstrate the ability to read, write and communicate in English, effectively, as it relates to area operations and functions.
• Must demonstrate ability to perform mathematical calculations as required in the work order documents.
• Must be able to demonstrate an understanding of various mechanical/electrical processes and theory of operations.
• Must be willing to handle additional responsibilities, such as employee involvement team participation.
• Past performance and, where applicable, performance improvement efforts will also be assessed. Special emphasis will be placed on performance and attendance over the past 24 months.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• High school diploma or equivalent
• Minimum of 24 months experience as a production operator preferred, equipment operator and/or MQA inspector.
• Must become a Qualified Fellow Employee (QFE).
• Due to the nature of the extrusion / blending area, six months experience as an Equipment Operator in the same area as the opening is preferred. The Wet Side also prefers six months experience in the same area as the opening.

Work Environment.

• Typically requires travel less than 5% of the time
• Daily interaction with Supervisor or designee.
• This position is required to ensure production standards are met.
• Works in a manufacturing environment.
• Must wear hearing protection safety shoes, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in areas.
• May be asked to assist with material from the warehouse or move product outside for disposition.
• Must be able to lift up to 50 lbs., unassisted, and up to 100 lbs., assisted.

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