Automation Director

3 weeks ago

US Petersburg VA USA Civica Rx Full time
About Civica Rx

Civica Rx 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.

Our mission is to ensure that patients have access to affordable, high-quality medications. We achieve this by developing and implementing innovative solutions that address the root causes of generic drug shortages.

Job Description

We are seeking an experienced Automation Director to join our team at Civica Rx. As a key member of our operations team, you will be responsible for developing and implementing the automation strategy for our manufacturing site.

The successful candidate will have a strong background in automation and manufacturing execution systems (MES), with experience in leading cross-functional teams and managing multiple projects simultaneously.

Key Responsibilities:

  • Develop and implement the automation strategy for the site
  • Lead the automation engineering function, including support of 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 a team of automation engineers, representing the automation engineering function to other partner groups
  • Support manufacturing and operations by providing strategic direction and tactical support, troubleshooting day-to-day issues and assigning personnel as necessary
  • Set and drive strategic priorities for the holistic systems technology landscape for the site, including oversight of new plants/facilities, changes to plant execution/operations systems, automation engineering systems, and develop and maintain validation lifecycle strategy
  • 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, 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.

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 Siemens PLCs 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.

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