Essential Duties and Responsibilities:

• Operational Technology Management:
  • System Architecture: Oversee the design, implementation, and maintenance of OT systems, including process control, automation, and manufacturing execution systems.
  • Risk Assessment: Evaluate risks associated with OT systems and develop mitigation strategies. Ensure robust cybersecurity measures to protect critical infrastructure.
  • Vendor Management: Collaborate with vendors and third-party providers to ensure seamless integration of OT solutions. Evaluate vendor compliance with data integrity standards.
• Responsible for all technology-related system integrations across different software platforms and systems.
• Maintain infrastructure systems, disaster recovery, and systems/network security with the systems engineering team. Responsible for Disaster Recovery and Business Continuity initiatives.
• Facilitates IT security audits and or investigations.
• Analyzes IT infrastructure and systems performance to assess operating costs, productivity levels, upgrade requirements, and other metrics and needs.
• Ensure operational requirements and coordinate with system requirements for future growth and strategy to align with highly available applications and systems.
• Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards in compliance with site procedures and industry standards.
• Consistently leading by example, being a role model and change agent for all team members and the corporate technology team.
• Mentor other IT and automation colleagues in the site technologies, IT procedures, and industry standards.
• Manages the implementation of software solutions across various functional areas.
• Automate the configuration, testing, monitoring, and backup of our process infrastructure.
• Research, test, and deploy software and hardware tools necessary on a project basis.
• Build and maintain tools to improve predictability and reliability of releases and deployments.
• Data Integrity and Compliance:
  • Champion Data Integrity: Develop and implement strategies to ensure data integrity across IT and OT systems.
• Data Integrity Controls Implementation
  • Define and enforce robust access controls for data entry, modification, and deletion.
  • Implement electronic signatures and audit trails to track changes and ensure accountability.
  • Validate data migration processes to prevent data corruption during system upgrades.
  • Collaborate with IT and OT teams to establish secure data transfer protocols.
  • Conduct risk assessments specific to data integrity and develop mitigation plans.
• Support operational technology and the process control network.
  • IT/OT network architecture development.
  • HMI/SCADA system development for Rockwell Factory Talk including:
    • SCADA graphics and database
    • Virtualized server systems.
    • 21 CFR Part 11 Compliance.
  • Rockwell/Allen Bradley Control Logix programming.
  • PLC hardware selection/control panel design.
  • Modification and expansion of the above systems in a qualified environment.
  • Qualification of automation systems for the pharmaceutical industry.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree Computer Science, Information Technology, or related field (Master’s preferred)
• Minimum 10+ years of experience in architecting, planning, and/or leading teams to implement OT solutions
• Demonstrated experience with minimum 2 years of the following systems: ERP, CRM, MES, PLM, QM, Analytics
• Excellent collaboration, oral, and written communication skills, including the ability to communicate/translate technical concepts in a business framework that non-technical people easily understand.
• Ability to build collaborative relationships and productive working partnerships across cross-functional teams.
• Capable of working independently against deadlines in an ambiguous, fast-paced, dynamic environment.
• Demonstrated ability to effectively lead and influence leaders and team members to choose new working methods.
• Understanding pharmaceutical manufacturing process and regulatory requirements and working knowledge of cGMP practices.
• Ability to work through and manage ambiguity to drive decisions in complex and dynamic situations· Proficiency in using scheduling software and ERP systems.
• Knowledge of CGMP regulations, data integrity guidelines, and FDA expectations.