Maintenance Technician, Process Equipment (# 317, # 318, # 605)

Civica Rx•Petersburg, VA

19h

About The Position

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 Position Summary The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment, operates in a highly technical environment that requires experience specifically in maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment, applies critical thinking and considers all business-impact factors before taking job-related actions that could lead to unintended consequences, such as unsafe events, equipment failure, and other risks. The Maintenance Technician, Process Equipment, should be able to apply independent judgment and perform in a small-company environment where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset, driving a positive team culture. These positions follow a 2-2-3, 12-hour day schedule: 6:00 PM-6:30 AM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

Requirements

High school diploma with 4 years of experience in executing maintenance to manufacturing equipment, or an associate’s degree or higher in Pharmaceutical Sciences, Engineering, or a related field is preferred.
Experience with sterile fill-finish manufacturing.
Knowledge of GMP, regulatory requirements, and industry best practices.
Ability to work autonomously and within established guidelines, procedures, and practices.
Experience in a continuous process improvement environment, including change management.
Experience in using Computerized Maintenance Management Systems.
Strong communication and collaboration skills, committed to meeting high-quality standards.

Nice To Haves

Knowledge of high-speed aseptic filling and isolator barrier system technology.
Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
Proficiency in Microsoft Office Suite.

Responsibilities

Support the day-to-day production activities in the production area.
First line of response in case of production equipment malfunction.
Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.
Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.
Support the coordination and execution of calibrations and preventative maintenance activities.
Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.
Proactively work with supports teams Ein developing solutions for equipment issues.
Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.
Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.
Assist R&D and MSAT on new product introduction and technology transfer activities.
Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
Periodically on call to monitor and respond to manufacturing equipment repairs and issues.
Other duties as assigned.