What are the responsibilities and job description for the IT Operations Engineer – 2nd Shift (515) position at BioSpace?
About Civica
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.
Shortages put patients at risk and waste hospital resources.
Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.
Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.
Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.
The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.
Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.
Join us. Learn more 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:
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.
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.
Shortages put patients at risk and waste hospital resources.
Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.
Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.
Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.
The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.
Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.
Join us. Learn more 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.
- 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.
- 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.
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.
