Manager, Automation & MES (Manufacturing Execution Systems)
Civica

About Civica

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.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

POSITION SUMMARY

The Manager of Automation and MES oversees a site-based team accountable for the development, implementation, and operational compliance of the Civica Petersburg process automation philosophy and associated industrial control systems (ICS) including facility, utility, and manufacturing processes, as well as supporting infrastructures. The Plant ICS system includes: DCS, SCADA, PLC, BMS, EMS and data systems such as historian and analytics solutions. As the functional leader, you have the ability to make decisions, and are capable of setting and balancing priorities. You must be able to manage multiple projects with frequent changes and are able to coordinate and manage project activities while involving cross-functional partners. You have a willingness to perform "hands-on" work in a dynamic, fast-paced start up environment. Incumbent provides technical expertise on Manufacturing and Compliance standards and processes to team members; and provides input on strategy to key business leaders.

MAJOR ACCOUNTABILITIES:

• Lead the Automation Engineering function supporting mission critical Automation Systems in the manufacturing of commercial and clinical products. The scope of this group will include support of the following systems:
  • SCADA and PLC systems
  • Process Automation and Building Management Systems
  • Central Monitoring Systems
  • Data Historians
• Accountable for the delivery of all aspects of plant execution/operations systems to support site commissioning, validation, and on-going safety, compliance, and quality manufacturing.
• Lead and manage the group of automation engineers and represent the Automation Engineering function to other partner groups such as IT, Quality, Validation; Manufacturing, Engineering & Technical Services, ensuring the quality of work and appropriate resources are in place to support ongoing initiatives, operations and projects requiring Automation Engineering Support
• Support Manufacturing and Operations by providing strategic direction and tactical support. Troubleshoot day-to-day issues, assigning personnel as necessary to provide comprehensive solutions.
• Set and drive strategic priorities for the holistic systems technology landscape for the site, including but not limited to oversight of new plants/ facilities, changes to plant execution/operations systems, automation engineering systems, develop and maintain validation lifecycle strategy etc. Responsible to implement, validate, maintain and govern S95/S88 Standards, Libraries, Interfaces & Systems.
• Accountable to develop and manage the Leads along with a high performing team to deliver on above responsibilities. Create and sustain a culture of innovation, quality, compliance, accountability, employee engagement, collaboration, diversity and inclusion.
• Responsible for inspection/audit readiness (internal and external) in relation to the Automation systems. Also accountable for adherence to cybersecurity corporate requirements, all engineering aspects of data integrity, and provide leadership support for alarm management.

• Assist and provide resources in various stages of the engineering project lifecycle from conceptual design, detailed design, specification, implementation, commissioning, qualification, trouble-shooting and continuous improvement of automation and instrumentation for the sterile injectable industry.
• Collaborate with functional and discipline heads and leads to develop solutions to issues that are immediately impacting business needs. Collaborates effectively with Operations, Quality, Regulatory, Process Development, Supply Chain, and other key groups involved in GMP manufacturing.
• Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
• Demonstrates excellent planning and organizational skills, with the ability to balance production and maintenance needs.
• Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment. Excellent communication skills; verbal & written.
• Forecasts and adheres to departmental budget, and responsibly manages cost center resources.

• A minimum of a bachelor's degree is required. Advanced degree, such as an MBA, is desired.
• Knowledge of systems such as Allen Bradley PLC platforms, Johnson Controls, Amega or DeltaV, SCADA systems, PI Historian, Siemens PLC S7, iFix, iHistorian, Industrial Ethernet networks, Profibus and AS-I networks.
• Knowledge and understanding of Data Integrity and how it applies to the BioTech Industry with specific focus on guidelines from the FDA.
• Exposure to batch and continuous processes found in the pharmaceutical and Biotech Industries is preferred.
• Experience with S88 and ASTM 2500 principles would be an advantage.
• 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.