Associate Director Automation
4 days ago
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.
Department of Veteran's Affairs, the U.Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
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. DCS, SCADA, PLC, BMS, EMS and data systems such as historian and analytics solutions. 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. 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. 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. 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. 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.
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. Forecasts and adheres to departmental budget, and responsibly manages resources.
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.
~ 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 excellent planning and organizational skills, with the ability to balance production and maintenance needs.
~ Excellent project management and time management capabilities; Forecasts and adheres to departmental budget, and responsibly manages cost center resources.
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 regulatory inspections.
Demonstrated management and delivery of large capital projects.
Keywords: Automation Director, Location:
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