Automation Director

1 month ago


Petersburg, United States Civica Full time
Job Summary

Civica is seeking a highly skilled and experienced Automation Director to lead our Automation Engineering function. As a key member of our team, you will be responsible for developing and implementing automation strategies, leading a team of automation engineers, and ensuring the quality and compliance of our automation systems.

Key Responsibilities
  • Develop and implement automation strategies to support site commissioning, validation, and ongoing safety, compliance, and quality manufacturing.
  • Lead and manage a team of automation engineers, providing guidance and support to ensure the quality and compliance of automation systems.
  • Collaborate with cross-functional departments and vendors to drive automation deliverables and ensure alignment with company goals.
  • Develop and maintain validation lifecycle strategies, implement, validate, maintain, and govern S95/S88 Standards, Libraries, Interfaces & Systems.
  • Ensure safety is integral to all activities and implement a culture of continuous improvement and best practices.
  • 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.
  • Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME).
Requirements
  • A minimum of a bachelor's degree or similar technical degree is required.
  • 10+ years progressive experience in automation or a related role in the pharmaceutical industry.
  • 5+ years of subject matter expertise with automation execution.
  • 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.
  • Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment.
  • Excellent communication skills; verbal & written.
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.

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