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

Position Summary

Civica is searching for an Automation Engineer on the second shift with experience in pharmaceutical drug product manufacturing. The Petersburg site serves as Civica’s new fill-finish facility, dedicated to the manufacture and supply of essential generic sterile injectable medications.

As a member of the Engineering Team, the successful candidate will be required to support system automation initiatives and perform troubleshooting that requires a good understanding of analytical problem-solving techniques, project management, lifecycle management, network, and virtual environments. The position requires a good understanding of programming, design, installation, and lifecycle management of manufacturing process controls, packaging equipment, aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies.

Essential Duties and Responsibilities:

• We are seeking a skilled individual who thrives in a fast-paced environment to support and implement our Automation solutions across our facility. As an Automation Engineer, your job responsibilities include:
• Supervisory Control and Data Acquisition systems (SCADA), preferably Rockwell’s FactoryTalk View Systems.
• Trouble-shoot process control applications (Rockwell and Siemens PLCs) utilizing Programmable Logic Controllers (PLC) and Human Machine interface (HMI)
• Support Rockwell’s Data Historian, AssetCentre, FactoryTalk Directory, etc.
• Troubleshoot day-to-day issues and provide guidance to Associate engineers.
• Good understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment.
• Development of detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
• Effectively interact and collaborate with cross-functional departments, and clients to meet company expectations.
• Independent, self-motivated, organized, able to multitask in a dynamic environment, and embrace a team-based culture that relies on collaboration for effective decision-making.
• Support ownership and administration of process control automation in a GMP-regulated environment.
• Generate and follow proper change control for any automation/process changes within the system.
• Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation, and control systems.
• Support new product introductions or new technology introductions by performing engineering assessments, engineering studies, implementing automation system configuration changes, and supporting engineering runs.
• Design and testing of newly installed and currently installed automation-based process and packaging equipment.
• Assist in the support of network advancements and new technologies as they pertain to networking architectures.

Basic Qualifications and Capabilities:

• Master’s degree and 2 years of Engineering/Automation experience, or bachelor’s degree & 4 years of Engineering/Automation experience, or associate degree and 6+ years of Engineering/Automation experience (Preferably Electrical or Computer Engineering).
• Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
• Knowledge and understanding of Data Integrity and how it applies to the Pharmaceutical Industry, with a specific focus on guidelines from the FDA.
• Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.
• Knowledge of systems such as Allen Bradley PLC platforms (ControlLogix , CompactLogix), and Studio 5000 software.
• Knowledge of Siemens PLCs and software (TIA Portal software)
• Knowledge of FactoryTalk Directory, FactoryTalk AssetCentre, FactoryTalk Data Historian, Factory Talk View SE & ME, and WIN911.
• Experience working in virtual environments. (ESXI version 7.0, VMware Workstation, Virtual Network Configuration). 

Preferred Qualifications:

• Experience in sterile fill-finish facility manufacturing.
• Experience with regulatory inspections.
• Programming Switches, Firewalls, and designing networking architecture is preferred.
• Thin Manager/Thin Clients, SQL Server design, implementation, and support. Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC and Wastewater systems

Physical Demands and Work Environment:

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. 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. The employee must occasionally lift and/or move up to 40 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.