Maintenance Technician III - Sterile Filling

Job Description

Job Description

The Maintenance Technician III 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.  This role requires the ability to perform mechanical and electrical troubleshooting to ensure optimal operation of the process equipment. The Maintenance Technician III will also perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects.  The Maintenance Technician III reports to a Supervisor, Maintenance. 

Job 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.
• Troubleshoot the following Automation systems; PLCs, HMIs, SCADA.
• Ability to interpret diagrams, drawing, PLC code and other schematics.
• 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.

Minimum Requirements:

• Experience in a regulated production environment, specifically responsible for equipment maintenance and performance
• Experience with some of following Automation systems; PLCs, HMIs, SCADA, Rockwell Inductive (Ignition) Aveva (Wonderware), Siemens, Emerson (GE) or B&R
• 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

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

Company Description

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.