Maintenance Technician IV

5 days ago

Toledo, Toledo, United States BioSpace, Inc. Full time
Job Summary

The Maintenance Technician IV - Biomanufacturing Specialist is responsible for performing ongoing corrective, predictive, and preventative maintenance for process equipment within the assigned operating area. This role requires the ability to perform mechanical and electrical troubleshooting to ensure optimal operation of the process equipment.

Key Responsibilities
  • 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.
  • Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs.
  • 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.
  • Provide training to operators for equipment set-up and for minor adjustments or repairs.
  • Install new equipment and oversee equipment upgrades according to site SOPs.
  • Perform 5S activities and maintain organization of operating areas.
  • 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 in performance of job responsibilities. This will include mathematical computation where needed.
  • Work with minimal supervision under the direction of 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.
  • Follow and maintain compliance with established MRO procedures and inventory control.
  • Serve as a project resource to PET to assist in the follow-up and timely implementation of projects and validation activities.
  • Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas. (Area Dependent)
  • Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
  • Perform other similar and related responsibilities as assigned by area management.
  • Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the manufacturing.
Requirements
  • 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.
  • Proficient with Computerized Maintenance Management Systems such as Maximo or SAP.
Preferred Background
  • High school graduate, vocational school graduate, or equivalent.
  • Associates in Engineering or a related discipline or equivalent mechanical trade school graduate preferred.
  • Previous experience with automated equipment preferred.
  • Training in mechanics, hydraulics, electronics, and testing equipment in electrical and/or mechanical troubleshooting.
  • Knowledge of data and materials maintenance systems such as SAP, KRONOS, or other MRP systems.
  • Experience with OEE, TPM, LEAN, or other Continuous Improvement systems.

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