Supervisor, Maintenance, Sterile Ops

Position Summary & Responsibilities

This position 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 classified areas up to a Class 100 aseptic environment. In addition, the role requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment.

The individual will also perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects.

• 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 Manager, Process Managers, 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 PET.

• 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
• Prior people leadership experience, including supervising, mentoring, or developing direct reports

• High school graduate, vocational school graduate, or equivalent
• Associate degree in engineering or a related discipline or equivalent mechanical trade school graduate
• Previous experience with automated equipment
• 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

12 hour – 2/2/3 Night shift

The work schedule listed reflects the employee’s expected…