Manufacturing Technician III, (Mechanic - Device Assembly) Day Shift

Great Oaks; Blue Ash (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

Great Oaks is seeking a Manufacturing Technician III (Mechanic - Device Assembly) to support device assembly operations on the manufacturing floor. The role includes setup, changeover, repairs, and preventive maintenance for equipment across production areas, with a focus on mechanical and electronic troubleshooting.

The incumbent will train others, support continuous improvement projects, and ensure adherence to GMP and safety procedures while collaborating with cross-functional teams.

Qualifications

• Experience in a regulated production environment is required.
• Ability to read, write, communicate and follow instructions in English.
• Ability to lift and handle equipment change parts, tooling, and materials.

Responsibilities

• Operate, monitor, troubleshoot, and perform maintenance tasks on device assembly equipment.
• Work collaboratively with technical resources to resolve equipment issues.
• Provide technical support to production technicians and resolve equipment-related issues including start-up and recipe format setup.
• Monitor equipment and perform preventative maintenance to prevent downtime.
• Perform batch records, GMP documentation, and CMMS entries.
• Adhere to SOPs, cGMPs, and safety/quality procedures.

Skills

Mechanical knowledge

Electronic knowledge

Verbal communication

Written communication

Interpret technical documents

Teamwork

Education

High school diploma or equivalent

Associate degree in engineering or mechanical trades

Tools

SAP

Job description

The Manufacturing Technician III, (Mechanic - Device Assembly) reports to the Supervisor or Manager on the Manufacturing floor, which supports Device Assembly operations. The position entails the execution of setup, changeover, repairs, and preventative maintenance for all equipment used in the production processes in various Classified/Non-Classified areas and performs the role of a Device Assembly Technician as needed. It requires the ability to perform mechanical and electronic troubleshooting in order to ensure optimal equipment performance. The Manufacturing Technician III will also provide basic mechanical training to Device Assembly Technicians and serve as a resource for the implementation of continuous improvement projects.

• This position will initially be a M-F 8-hour dayshift position. Eventually this position will transition to The dayshift 6AM-630PM 2-2-3 rotation.

Job Responsibilities

• Operate, monitor, troubleshoot, and perform maintenance tasks on device assembly equipment.
• Work collaboratively with technical resources to resolve equipment issues as needed.
• Act as a first-line technical resource for the team. Provide technical support to production technicians. Resolve equipment-related issues, including equipment start-up, machine recipe selection, recipe format set-up, critical sensor challenge, and production issues.
• Proactively monitor equipment and perform preventative maintenance tasks. Identify and investigate abnormal conditions and potential defects to prevent unplanned equipment downtime.
• Perform technician tasks as required including start-up, equipment operation, manual inspection, batch execution, material handling, rework, cleaning, housekeeping and line clearance activities.
• 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.
• Monitor material quality of incoming, in-process and finished materials. Promptly elevate concerns to Lead Technician and Manager/ Supervisor as needed.
• Perform batch records, GMP documentation, and CMMS entries. Perform mathematical computation as needed.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety and quality procedures.

Other Responsibilities

• Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis. Lead Level 0 problem-solving on equipment related issues as needed.
• Act as a certified OJT trainer on the team on assigned equipment or process tasks. Train and conduct evaluations on other team members for training qualifications.
• Review process documents such as operational SOPs, PM procedures, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Execute protocols as required as a part of equipment qualification and process validation work
• Be flexible and support other work areas within the Process Execution Team as needed
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
• Acquire and maintain all required certifications and qualifications for the assigned work area
• Strong mechanical and electronic knowledge and aptitude
• Strong verbal and written communication skills
• 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.

Minimum Requirements

• Prior 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

Preferred Requirements

• 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
• Associates degree 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