Maintenance Technician IV - Sterile Operations

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• 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 minimal supervision under the direction of the Maintenance Supervisor, Process Supervisor/Manager, 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.

• 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.

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

Minimum Qualifications

• 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 aseptic/sterile manufacturing environment requirements including gowning, environmental monitoring awareness, and clean room behavior.
• Ability to independently diagnose and resolve equipment failures with limited supervision; make 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…