Maintenance Specialist – Production (465) - Civica Rx

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

Job Description

The Maintenance Specialist, Production, is responsible for supporting manufacturing with equipment maintenance, issues, or projects that are mechanical in nature.  This position is considered the technical expert that 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 and during shutdowns. The Maintenance Technician should possess comprehensive and specialized knowledge/skills in procedures, techniques, tools, materials, and equipment needed for the position.

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

Essential Duties and Responsibilities:

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

• 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.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimize impact on operations.
• Participate in FAT, SAT, and other activities with equipment vendors.
• Makes recommendations on equipment upgrades.
• Recommends, order 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 Preventative Maintenance (PM) tasks relating to production equipment maintenance needs.
• Assures smooth or improved operation of production equipment by means of any of the following: planning and coordinating maintenance functions with supervisors, Senior Production Operators, and engineering personnel; using historical data to establish and monitor preventive and predictive maintenance procedures; troubleshooting and/or repairs.
• Prepares purchase requisitions for spare parts used on production equipment as needed.
• Ensure all work carried out and 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
• 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.
• 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 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.