Maintenance Technician IV - IDAP (Nights)

Great Oaks; Blue Ash (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Great Oaks is seeking a Maintenance Technician IV, DAP in Ohio to perform ongoing corrective, predictive, and preventive maintenance on process equipment in a GMP setting, including setup/changeover support where needed. The role requires strong mechanical and electrical troubleshooting, data monitoring, and support for continuous improvement initiatives.

The technician will train production operators on equipment setup and minor repairs, ensure cGMP documentation accuracy, and work with limited

Qualifications

• Experience with corrective, preventive, and predictive maintenance on automated process equipment in GMP environments.
• Ability to read electrical schematics and mechanical drawings; troubleshoot electronics, hydraulics, pneumatics.
• Familiarity with controlled (CNC) manufacturing environment requirements and cGMP documentation.

Responsibilities

• Perform emergency repair, inspection, and preventive maintenance on process equipment per SOPs.
• Monitor equipment performance via data and use tools to troubleshoot issues.
• Provide operator training on equipment setup and adjustments; support continuous improvement projects.

Skills

Troubleshooting

Electrical

Mechanical

CNC familiarity

Education

High school diploma or equivalent

Associate degree in a relevant field

Tools

Maximo

SAP

ERP systems

Job description

Job Description

The Maintenance Technician IV, DAP is responsible for performing ongoing corrective, predictive, and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various controlled areas up to a Controlled Not Classified (CNC) environment. It requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. In addition, the individual will perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects.

Job Description

The Maintenance Technician IV, DAP is responsible for performing ongoing corrective, predictive, and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various controlled areas up to a Controlled Not Classified (CNC) environment. It requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. In addition, the individual will perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects.

Job Responsibilities

Operations

• Complete emergency repair, rebuilding, changeover, and inspection work on process-related equipment. Install, inspect, test, adjust, repair, and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner.
• Responsible for equipment and system performance through data monitoring within the assigned operating area.
• Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment.
• Install new equipment and oversee equipment upgrades according to site SOPs.
• Perform 5S activities and maintain organization of operating areas.
• Work with limited supervision, identifying and prioritizing maintenance needs within the assigned operating area in coordination with the Maintenance Facilitator, Process Facilitator, Engineer, or other activity leads.
• Perform roles of Technician and Mechanical Technician as required to support daily PET activities.
• Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs.
• Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

Documentation & Compliance

• Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety procedures in accordance with OSHA requirements and guidelines.
• Be familiar with Material Safety Data Sheets for area chemicals.
• Perform batch record and GMP documentation entries. Maintain records and/or logs as required. This will include mathematical computation where needed.
• Follow and maintain compliance with established MRO procedures and inventory control.

Training & Development

• Provide training to operators for equipment set-up and for minor adjustments or repairs.
• Responsible for maintaining Gowning and controlled-environment certifications as required to support assigned work areas (area dependent).

Minimum Qualifications

Education & Experience

• Demonstrated experience performing corrective, preventative, and predictive maintenance on automated process equipment in a regulated GMP environment.
• Demonstrated mechanical and electrical troubleshooting proficiency, including mechanics, hydraulics, pneumatics, and electronics.
• Familiarity with controlled (CNC) manufacturing environment requirements, including gowning, environmental monitoring awareness, and clean room behavior.
• Ability to independently diagnose and resolve equipment failures with limited supervision; makes independent decisions regarding own maintenance work.
• Proficient in Computerized Maintenance Management Systems (e.g., Maximo, SAP); independently operates CMMS to create, update, and close work orders.
• Demonstrated ability to complete and review GMP documentation accurately, including work orders, batch records, and maintenance logs per cGMP requirements.
• Ability to read and interpret electrical schematics, mechanical drawings, and equipment manuals.
• Ability to effectively understand, read, write, communicate, and follow instructions in the English language.

Preferred Qualifications

• High school diploma or GED Associate degree or vocational/trade school certification in a relevant discipline (e.g., industrial maintenance, electrical, mechanical, instrumentation) preferred.
• 4+ years of experience in equipment maintenance within a regulated pharmaceutical or GMP manufacturing environment.
• Experience with OEE, TPM, LEAN, or other continuous improvement methodologies.
• Knowledge of data and materials systems such as Maximo, SAP, ADP, KRONOS, or other MRP/ERP systems.
• Experience with automated pharmaceutical manufacturing equipment (e.g., inspection, assembly, packaging, or filling equipment).

Physical & Work Environment

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. ?

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Work Schedule

12-hour night shift – 2/2/3 - 6:00pm to 6:30am
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.