Manufacturing Technician III, Mechanic - Device Assembly (Days)

Job Summary

Required Qualifications

• •Must have experience in a regulated production environment, specifically responsible for equipment maintenance and performance
• •Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language
• •Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair
• •Must be able to acquire and maintain all required certifications and qualifications for the assigned work area
• •Strong mechanical and electronic knowledge and aptitude
• •Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team
• •Proven ability to work effectively in a team environment
• •Ability to interpret technical documents
• •Candidate should possess the ability to work in and adapt to a changing/demanding environment
• •Some overtime may be required with minimal advance notice to support business needs
• •Must be able to operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) as the need arises to safely move, store or deliver material to the proper location
• •Must be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls
• •Must perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety and quality procedures
• •Must be able to perform batch records, GMP documentation, and CMMS entries
• •Must be able to perform mathematical computation as needed
• •Must be able to act as a certified OJT trainer on the team on assigned equipment or process tasks
• •Must be able to train and conduct evaluations on other team members for training qualifications
• •Must be able to review process documents such as operational SOPs, PM procedures, forms and batch records for accuracy
• •Must be able to identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise
• •Must be able to execute protocols as required as a part of equipment qualification and process validation work
• •Must be flexible and support other work areas within the Process Execution Team as needed
• •Must be able to perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed
• •Must be able to operate, monitor, troubleshoot, and perform maintenance tasks on packaging equipment including picker, sorter, labeler, packer, checkweigher, printer, inspection equipment, palletizer, stretch-wrapper and conveyors
• •Must be able to work collaboratively with technical resources to resolve equipment issues as needed
• •Must be able to act as a first-line technical resource for the team
• •Must be able to provide technical support to production technicians
• •Must be able to resolve equipment-related issues including equipment start-up, machine recipe selection, recipe format set-up, critical sensor challenge, and production issues
• •Must be able to proactively monitor equipment and perform preventative maintenance tasks
• •Must be able to identify and investigate abnormal conditions and potential defects to prevent unplanned equipment downtime
• •Must be able to perform technician tasks as required including start-up, equipment operation, manual inspection, batch execution, material handling, rework, cleaning, housekeeping and line clearance activities
• •Must be able to monitor material quality of incoming, in-process and finished materials
• •Must be able to promptly escalate concerns to Lead Technician and Manager/ Supervisor as needed
• •Must be able to perform lean activities and process improvement work such as performing 5S in the work area
• •Must be able to participate in problem-solving
• •Must be able to manually track performance data for OEE and process improvement analysis
• •Must be able to lead Level 0 problem-solving on equipment related issues as needed
• •Must be able to review process documents such as operational SOPs, PM procedures, forms and batch records for accuracy
• •Must be able to identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise
• •Must be able to execute protocols as required as a part of equipment qualification and process validation work
• •Must be able to be flexible and support other work areas within the Process Execution Team as needed
• •Must be able to perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed
• •Must be able to work in and adapt to a changing/demanding environment
• •Must be able to work effectively in a team environment
• •Must be able to interpret technical documents
• •Must be able to acquire and maintain all required certifications and qualifications for the assigned work area
• •Must be able to have strong mechanical and electronic knowledge and aptitude
• •Must be able to be capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team
• •Must be able to have proven ability to work effectively in a team environment
• •Must be able to have the ability to interpret technical documents
• •Must be able to have the candidate should possess the ability to work in and adapt to a changing/demanding environment
• •Must be able to have some overtime may be required with minimal advance notice to support business needs

Desired Qualifications

• •High school graduate, vocational school graduate or equivalent
• •Minimum three years of experience in a regulated production environment, specifically responsible for equipment maintenance and performance
• •Associate's in engineering or mechanical trade school graduate preferred
• •Previous experience with automated equipment
• •Training in mechanics, hydraulics, and electronics systems
• •Knowledge of computerized maintenance management system such as SAP
• •Experience with OEE, TPM, LEAN or other Continuous Improvement methodology