Maintenance Technician IV, Lead
RESILIENCE US INC
A career at Resilience is more than just a job – its an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company thats changing the way medicine is made. Were building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary & Responsibilities
This position is responsible for performing ongoing corrective, predictive, and preventativemaintenance 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 variousclassified areas up to a Class 100 aseptic environment. It requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. Inaddition, the individual will perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects.
Lead the effort to complete emergency repair, rebuilding, changeover, and inspection workon process related equipment. Install, inspect, test, adjust, repair, and perform lineturnarounds, changeovers, and preventative maintenance per established procedures in atimely and efficient manner
Complete and review documentation and required functions in the work order system toclose out activities in compliance with cGMPs
Responsible for equipment and system performance through data monitoring within theassigned operating area
Use a variety of testing, tools, and measuring equipment in the efficient maintenance andtroubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, andmechanical line equipment
Provide training to operators and Process Maintenance Technicians for equipment set-upand for major and minor adjustments or repairs
Lead the effort to install new equipment and oversee equipment upgrades according to siteSOPs
Lead and 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 computationwhere needed
Perform roles of Technician and Mechanical Technician as required to support daily PETactivities
Teach 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 ofprojects and validation activities
Responsible for maintaining Aseptic Processing and Gowning certifications as required tosupport 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. Emergencyovertime may be required with little notice to ensure operation of equipment within the PET.
Minimum Qualifications
Significant experience in a regulated production environment, specifically responsible forequipment maintenance and performance
Ability to effectively understand, read, write, communicate, and follow instructions in theEnglish language
Ability to lift and handle equipment change parts, tooling, and materials associated withequipment maintenance and repair