Maintenance Technician Production Specialist
5 days ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.
Our mission is to ensure that patients have access to essential generic medications, and we are committed to making a positive impact on the lives of those who need them most.
Job DescriptionThe Maintenance Technician, Production, is a critical role within our organization, responsible for supporting 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.
This position requires a high level of technical expertise, as well as excellent communication and problem-solving skills. The successful candidate will be able to work independently and as part of a team, with a strong focus on safety and quality.
Essential Duties and Responsibilities:- Ensure a safe and effective working environment
- Support manufacturing with equipment maintenance, troubleshooting, and repairs on process equipment
- Participate in FAT, SAT, and other activities with equipment vendors
- Makes recommendations on equipment upgrades
- Recommends, orders parts, and installs machine modifications
- Assists with plant safety programs and safety awareness
- Prepare and update Preventative Maintenance (PM) tasks relating to production equipment maintenance needs
- Ensure all work carried out and equipment installed is safe, effective, and in compliance with the appropriate industry standards
- Experience in a sterile fill finish required
- Requires a high school diploma or GED and 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
- Must be able to communicate, speak/write, and comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals
- Experience with ATEC, Terminal Sterilizers, Parts Washers, and Autoclaves
- Associate's degree in a technical discipline, technical school / Auto Mechanic Program certificate
- Experience in a process improvement environment, including change management
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