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||Petersburg, VA United States
|| Biotechnology and Pharmaceutical
Process Engineering and Automation Manager |
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica's mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country's most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.
The Manager; Process Engineering and Automation will lead the Automation and Process Engineering teams for the Petersburg, Virginia facility (just outside of Richmond), including all FTEs and contract personnel to manage, support, and coordinate the work of these groups. This role will require the ground-up development of the Automation systems and Process Equipment start up; providing steering direction and team development.
We are seeking an exceptional leader who thrives in a fast-paced environment to oversee our Automation and Process Engineering groups. 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 work setting. Incumbent provides technical expertise on Manufacturing and Compliance standards and processes to team members; and provides input on strategy to key business leaders.
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
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.
Excellent understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment.
Mentor, coach, train and evaluate a team of junior and senior engineers. Lead hiring efforts for team growth and attrition.
Effectively interact and collaborate with cross-functional departments and clients in order to meet company expectations.
Establish and maintain continuous improvement projects in support of company activities and growth
Qualifications & Requirements
Required Qualifications and Education
Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.
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, team building, 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.
Relevant Experience Desired
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 principals 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.
Over the past two decades, shortages of generic, injectable drugs critical to the lifesaving work of hospitals in the United States have become commonplace. These drug shortages are so ubiquitous that hospitals and health care systems now maintain permanent drug shortage response teams that seek alternatives to unavailable drugs.
As a result, time that hospital pharmacists, technicians, nurses and others would prefer to spend caring for patients is spent ensuring that the patients who most need short-supply drugs get whatever supply is available.
Civica was created to reduce and prevent drug shortages and the price spikes that can accompany them. Its mission is to make quality generic medicines accessible and affordable to everyone.
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