civica Rx - Petersburg, VA

posted 16 days ago

Full-time
Petersburg, VA
Chemical Manufacturing

About the position

The Associate Director of Information & Operational Technology (I&OT) leads Civica's infrastructure, networks, cybersecurity, and compliance efforts for the Petersburg site. This role ensures security, reliability, and regulatory compliance. The candidate will partner with a team of I&OT professionals and consultants, collaborating with cross-functional stakeholders to integrate systems seamlessly.

Responsibilities

  • Develop and implement strategies for integrating I&OT systems to enhance operational efficiency and security.
  • Collaborate with cross-functional stakeholders to design, develop, and maintain I&OT Networks and Cybersecurity needs in GMP and non-GMP areas.
  • Drive the development of policies and innovative computerized solutions to achieve results.
  • Responsible for all technology-related system integrations across different software platforms and systems such as Asset Management System, Active Monitoring System, Operator Management and Access Control System, Alarm Management System, Disaster Recovery System, Historians.
  • Manage yearly budgets.
  • Develop and implement strategies to ensure data integrity and compliance across I&OT systems.
  • Define and enforce Management of Change process through cross functional collaboration.
  • Collaborate with vendors and third-party providers through the entire lifecycle of projects.
  • Proficient with 21 CFR part 11.
  • Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards in compliance with site procedures and industry standards.
  • Define processes and tools to improve predictability and reliability of I&OT Systems.
  • Educate other I&OT and automation colleagues in the site technologies, I&OT procedures, and industry standards.
  • Consistently leading by example, being a role model and change agent for all team members and the corporate technology team.

Requirements

  • Bachelor's degree in engineering, Information Technology, or related field (Master's Degree preferred).
  • Minimum 12+ years of experience in architecting, planning, implementing, and maintaining IT & OT solutions in a regulated environment.
  • Experience with cybersecurity frameworks and standards (e.g., NIST, IEC 62443).
  • Demonstrated experience with designing and integrating complex OT systems with IT.
  • Demonstrated experience with integrating multiple IT & OT systems to drive operational and security objectives.
  • Excellent collaboration, oral, and written communication skills, including the ability to communicate/translate technical concepts in a business framework.
  • Ability to build collaborative relationships and productive working partnerships across cross-functional teams.
  • Ability to work through and manage ambiguity to drive decisions in complex, fast-paced, and dynamic environment.
  • Demonstrated ability to effectively lead and influence leaders and team members to choose new working methods.
  • Knowledge of pharmaceutical manufacturing processes, regulatory requirements, data integrity guidelines, and FDA expectations.

Nice-to-haves

  • Certifications such as IEC62443, GICSP or PMP (Project Management Professional) are advantageous.
  • Experience in sterile fill-finish facility manufacturing.
  • Experience with regulatory inspections.
  • Programming Switches, Firewalls, and custom scripts.
  • Experience with Thin Clients, SQL Server design, implementation, and support.
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