Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica's plans and progress at www.civicarx.org
Job Description
The Associate Director of Automation and MES is responsible for developing and implementing the Automation strategy and 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.
Essential Duties and Responsibilities:
Develop the automation strategy for the site.
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:
Data Historians
Central Monitoring Systems
Process Automation and Building Management Systems
SCADA and PLC systems
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.
Mentor, coach, train and evaluate a team of automation engineers.
Implement automation policies and related procedures based on regulations and industry standards.
Provide oversight in the authoring and review of SOPs and system support.
Analyze operational process problems and recommend appropriate corrective and preventative actions.
Participate in the site wide teams to provide cybersecurity alignment and direction.
Effectively interact and collaborate with cross-functional departments and vendors to drive automation deliverables.
Establish and maintain continuous improvement projects.
Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME).
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.
Forecasts and adheres to departmental budget, and responsibly manages resources.
Implement a culture of continuous improvement and ensure the adoption of best practices. Ensure safety is integral.
Ensure safety is integral to all activities.
Basic Qualifications and Capabilities:
A minimum of a bachelor's degree or similar technical degree is required.
10+ year's progressive experience in automation or related role in the pharmaceutical industry.
5+ years of subject matter expertise with automation execution.
Experience with writing software test plans, user requirements, and system design documents.
Strong knowledge of programming and troubleshooting Rockwell or SiemensPLCs and Rockwell or Siemens FTView, GE iFix, and/or Wonderware System Platform HMIs.
Strong knowledge of Computerized Systems, Compliance regulations and standards.
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.
Preferred Qualifications:
Knowledge of Database/Historian (SQL, AVEVA PI).
Knowledge of Vmware and virtualization
Basic networking knowledge.
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.
Demonstrated management and delivery of large capital projects.
Subject matter expertise with Computerized Systems Validation (CSV)
Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.
