Associate Director IT OT

Essential Duties and **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.Minimum Qualifications (Knowledge, Skills, and Abilities)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.Preferred **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.

Created: 2025-02-19