Maintenance Specialist-2nd shift (Richmond)

Essential Duties and Responsibilities :

The Maintenance Specialist Production is responsible for supporting manufacturing with equipment maintenance, issues, or projects that are mechanical in nature, including troubleshooting, and repair of electrical (110V and 24VDC) and electronic systems and devices for Production and Utility Equipment on the 2nd shift. This position is considered the technical expert who performs, assists, and trains mechanics and production operators in troubleshooting, making repairs, and making improvements to equipment. The Maintenance Specialist is assigned to the manufacturing lines, where they lead and coordinate all maintenance efforts throughout the year, as well as during shutdowns. The Maintenance Specialist should possess comprehensive and specialized knowledge / skills in procedures, techniques, tools, materials, and equipment needed for the position.

The site serves as a new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.

The essential functions include, but are not limited to, the following :

Perform troubleshooting and basic repair of electrical (110V and 24VDC).

Demonstrated ability to ensure a safe and effective working environment.

Support manufacturing with equipment maintenance, troubleshooting, and repairs on process equipment, including Fillers with integrated Isolators, ATEC processing, Terminal Sterilizer, Parts Washers, Autoclaves, Single-Use Technology, and Aseptic Process Simulations.

Perform equipment maintenance, troubleshooting, and repairs on general and clean utilities as required.

Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent of minimizing impact on operations.

Participate in FAT, SAT, and other activities with equipment vendors.

Makes recommendations on equipment upgrades.

Recommends, orders parts, and installs machine modifications.

When necessary, review all Maintenance Task Lists, SOPs, and other relevant documentation to initiate any changes after review.

Assists with plant safety programs and safety awareness.

Prepare and update Preventive Maintenance (PM) tasks relating to production and utilities equipment maintenance needs.

Assures smooth or improved operation of production equipment utilizing any of the following : planning and coordinating maintenance functions with supervisors, production operators, and engineering personnel; using historical data to establish and monitor preventive and predictive maintenance procedures; troubleshooting and / or repairs.

Prepare purchase requisitions for spare parts used on production equipment as needed.

Ensure all work is carried out and the equipment installed is safe, effective, and in compliance with the appropriate industry standards.

All other duties on an as-needed basis, including but not limited to shutdown support and project support.

Train and teach others how to perform basic routine maintenance operations.

Develop or adapt new processes and procedures for the work area to improve performance and increase efficiency.

Analyze Preventative Maintenance routines and ensure appropriateness and value.

Basic Qualifications and Capabilities :

Experience in a sterile fill finish required.

Associates degree in a technical discipline, technical school, or related field preferred with a minimum of 4+ years of applicable experience in the pharmaceutical industry.

Knowledge of GMP and industry best practices.

Ability to complete all paperwork neatly, correctly, and in accordance with Company guidelines.

Proficient in training others on general maintenance skills.

Must be able to communicate, speak / write, and comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals.

Effective organization skills and attention to detail.

Basic math skills to perform required calculations.

Visual ability to detect defects.

Work schedule adjustments may be required.

Ability to work autonomously and within established guidelines, procedures, and practices.

Preferred Qualifications :

Experience in clean utilities preferred.

Experience with ATEC, Terminal Sterilizers, Parts Washers, and Autoclaves.

Experience in a process improvement environment, including change management.