Job Description:

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 IT Operations Engineer, 2nd Shift, is responsible for providing technical support and assistance to users in Manufacturing, Engineering, and QC functions. This role involves working with multi-functional teams to support various GXP systems and resolve user issues. Additionally, they assist in executing projects that support department goals.


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


The Essential Duties and Responsibilities include, but are not limited to, the following:

• Provide support for laboratory, manufacturing, and business systems.


• Perform user access review and account management activities.


• Assist with the installation, configuration, testing, maintenance, and technical training of IT systems.


• Monitor, resolve, and document user-reported issues and computer system risks, taking corrective and preventative actions or escalating as necessary.


• Track reported issues and other actions in a ticketing system.


• Support periodic reviews of GXP systems.


• Check the success or failure of disaster recovery solutions; backup and restore. Escalate to the necessary resources.


• Support domain control and Active Directory for Process Control Network and Laboratory (e.g., Password reset, Unlock User account).


• Participate in project-based work as assigned.


• Communicate with users on incident progress, changes, and outages.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's degree with 6+ years of experience in computerized system or automation roles in the pharmaceutical or biotechnology industry.


• Understanding systems and applications in laboratories, quality, ERP, business, printing, and network monitoring.


• A familiarity with lab instruments, their functions, and their requirements.


• High level of analytical, problem-solving, and decision-making skills.


• Interpersonal skills, including telephone & email communication, active listening and customer-care


• Ability to diagnose and resolve technical issues.


• Ability to work independently, multi-task, and adapt to changes quickly in a fast-paced environment.


• Understanding of support tools, techniques, and how technology is used to provide IT services


• Knowledge of Data Integrity and how it applies to the Pharmaceutical Industry.

Preferred Qualifications

• Familiarity with Operational Technology components including networks, historians, and switches.


• Familiarity with 21 CFR Part 11 and GAMP 5.


• Working knowledge of quality systems.


• Experience in the administrative features of Microsoft's enterprise systems, including M365, Entra, and SharePoint.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:


The physical demands described here represent those that must be met by an employee to perform the essential functions of this position successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or listen. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk; sit; and reach with hands and arms. Furthermore, the employee must be capable of successfully passing aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually low to moderate.


The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable. Apply Now