Technician, Operations (Operator w/Mechanical Skill)

Job Description

Position Overview – Essential Functions Essential Functions include, but are not limited to:

• Operates automated and non-automated packaging equipment according to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs)

• Prepares packaging equipment for production according Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs)

• First responder to challenges with packaging equipment

• Performs equipment set-up and dial on packaging equipment including but not limited to: product flow alignment, container size change adjustment, selection of

• correct qualified recipe parameters, set-up of qualified vision/inspection systems and verification of proper functionality of detection/rejection systems

• Ensure all tasks are completed in a safe manner

• Partners with maintenance personnel to reduce overall line downtime, and develop a deeper operational knowledge of equipment.

Primary Activities Primary Activities include, but are not limited to:

Operates automated and non-automated packaging equipment according to SOPs and GMPs:

• Load packaging material into process flow

• Move packaging material to different locations on the packaging line

• Inspect material rejected from equipment for defects prior to repackaging

• Waste material which cannot be repackaged

• Utilizing Tracksys data, trend and escalate equipment performance issues to maintenance and reliability teams as appropriate.

• Document activities within applicable batch documentation

Prepares and maintains packaging equipment for production according to SOPs and GMPs:

• Clear/Clean packaging equipment

• Inspect packaging equipment post cleaning

• Setup and Adjust the equipment

• Use appropriate tools

• Ensure proper alignment

• Ensure proper clearances

• Partners with maintenance personnel to assist with non-routine equipment repairs, including helping with repairs under guidance of maintenance, initiating work

• orders and retrieving parts from the stockroom as required.

• Provides occasional assistance to maintenance personnel that are executing PMs in order to develop a better operational understanding of the equipment functionality

First responder to challenges with packaging equipment:

• Determine if the challenge is due to the equipment or the component being run on the equipment

• Gather/Document key information at time of the challenge to aide in current and if necessary, future trouble shooting activities

• Make minor equipment adjustments as needed to return the equipment to a functional state

• Document activities using the computerized maintenance management system

• Use technical manuals for troubleshooting/verification of proper set-up and functionality

• Leverage vendor training when troubleshooting

• Escalate to Maintenance when the challenge/issue has not been resolved within the expected timeframe or requires modification of control systems, electrical

• troubleshooting, advanced troubleshooting or significant equipment failure has occurred.

Ensure all tasks are completed in a safe manner:

• Follow established safety standards while following SOPs and GMPs

• Actively take accountability for personal safety as well as the safety of others.

• Identify, report, and document unsafe conditions

• Recognize and utilize safety equipment when needed

Education / Skill Requirements

Required:

• High School diploma or equivalent and 2 years maintenance experience with a focus in industrial, pharmaceutical, food industry, and/or laboratory equipment

• OR An applicable Associates Degree.

Preferred:

• Ability to read controller logic and electrical diagrams.

• Experience with lock-out-tag-out (LOTO)

#MSJR

Required Skills:

Analytical Problem Solving, Biological Manufacturing, Cleanroom Gowning, Computer Literacy, Document Management, Equipment Repairs, General Safety, GMP Operations, Good Manufacturing Practices (GMP), Laboratory Processes, Machinery Operation, Maintenance Troubleshooting, Manufacturing Quality Control, Package Management, Packaging Equipment, Packaging Machinery, Packaging Management, Packaging Operations, Packaging Processes, Pharmaceutical Manufacturing, Production Scheduling, Safety Standards, Shift Work