Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.
Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
As a member of the Engineering and Technical Services Automation Team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem-solving techniques, project management, lifecycle management, network and virtual environments, and Operational Excellence. The position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, packaging equipment, Aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies.
Accountabilities & Responsibilities
We are seeking an exceptional 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:
- Work schedule flexibility as required to support 24/7 operations, requiring occasional afterhours engineering coverage.
- Supervisory Control and Data Acquisition systems (SCADA) preferably Rockwell’s FactoryTalk View Systems
- Developing and trouble-shoot process control applications utilizing Programmable Logic Controllers (PLC) (Rockwell and Siemens PLCs)
- Develop and support Rockwell’s Data Historian, AssetCentre, FactoryTalk Directory, etc.
- Troubleshoot day-to-day issues and provide guidance to junior engineers.
- Excellent understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment.
- Development of detailed specifications, engineering documents, SOPs, and engineering standards.
- Effectively interact and collaborate with cross-functional departments and clients to meet company expectations.
- Establish and maintain continuous improvement projects in support of company activities and growth.
- Ownership and administration of process control automation in a GMP regulated environment.
- 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.
- Support a safe working environment by complying with all pertinent environmental health and safety practices, rules, and regulations.
- Design and testing of newly installed and currently installed automation-based process and packaging equipment.
- Follow proper change control for any automation/process changes within the system.
- Lead and support of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems.
- Support Network advancements and new technologies as it pertains to networking architectures.
Master’s degree and 3 years of Engineering/Automation experience or Bachelor’s degree & 7 years of Engineering/Automation experience or Associate’s degree and 12 years of Engineering/Automation experience.
- Knowledge of systems such as Allen Bradley PLC platforms, (ControlLogix and CompactLogix) Studio 5000 software
- Knowledge of Siemens PLCs and software (TIA Portal software)
- Knowledge of FactoryTalk Directory, FactoryTalk AssetCentre, FactoryTalk Data Historian and WIN911,
- Knowledge and understanding of Data Integrity and how it applies to the Pharmaceutical Industry with specific focus on guidelines from the FDA.
- Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities.
- Experience with regulatory inspections.
- Experience in sterile parenteral manufacturing.
- Experience with Aseptic Filling Systems (Fill lines and isolators)
- Knowledge/Experience of working in a GMP Environment
- Experience working with virtual environments. (ESXI version 7.0, VMware Workstation, Virtual Network Configuration)
- Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment. Excellent communication skills; verbal & written.
- B.S. or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, or related Life Science Engineering.
- Programming Switches, Firewalls, and designing networking architecture is preferred.
- Strong control system automation background. Designing, installation, programming, validation of automated and computerized systems.
- Knowledge of industry standards for automated systems, virtual environments, IDMZs, and validation of computerized systems.
- Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
- 5+ years combined experience with the following product platforms:
- Rockwell PLCs (Control & Compact)
- Rockwell HMIs (IPC and PanelViews)
- SQL Server design, implementation, and support.
- Independent. Self-motivated, organized, able to multi-task in a dynamic environment.
- Ability to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
- Working knowledge and experience with aseptic filling equipment, packaging equipment and single-use equipment.
- Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC and Wastewater systems.
- Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.