Operational Technology Engineer (OTE)

Responsibilities

• Operational Technology Infrastructure Management: Act as the interface between Automation Engineering and Information Technologies representing Operational Technology priorities to meet the requirements of both organizations.
• Advice on best OT practices for network, servers, pc, and industrial equipment configurations for resiliency and uptime.
• Cordination and communication with facilities and manufacturing of equipment outages related to OT and IT projects and work.
• System Integration and Automation: Assist automation team troubleshoot and problem solve issues related to OT and IT systems including navigating the IT support matrix.
• Ensure data integrity compliant practices and procedures are in place, maintaining accurate and secure data storage and transmission.
• Work with engineering on manufacturing equipment to add domain integration for Active Directory user administration.
• Contribute to system and data archiving strategies and procedures for disaster recovery, and business continuity in the face of disruptions.
• Support the maintenance and troubleshooting of ESXi edge computing devices hosting manufacturing system automation.
• Support PLC level networking infrastructure hardware maintenance and troubleshooting.
• May direct the work of third-party vendors and/or partners to meet contract specified deliverables, performance or business objectives.
• Process Optimization and Continuous Improvement: Continual support of maintaining cybersecurity posture in increasingly sophisticated threat landscape. Investigate and introduce proactive and adaptive approaches and utilities. Stay up-to-date with industry trends and emerging technologies related to operational technology, cyber security, and data integrity, and provide recommendations for their implementation.
• Compliance and Documentation: Ensure operational technology systems comply with relevant regulatory requirements, including GMP guidelines and industry standards. Support vulnerability risk assessments with Agilent IT security, strategize mitigation, compensating controls, tracking, and impacts to facility. Work closely with Automation Engineers to understand risks and impact from patches and upgrades on qualified GMP equipment.
• Maintain accurate documentation of system configurations, changes, and validation activities to support audits and regulatory inspections.
• Create and lead change controls related to operational technology initiatives.
• Create and update procedures to drive operational efficiency and compliance.
• Create and lead functional test for OT changes, also provide technical subject matter expert review of qualification protocols.

Qualifications

• Bachelor's or master's degree or equivalent.
• 4+ years’ experience in automated manufacturing.
• GMP manufacturing experience preferred.
• Strong knowledge of operational technology systems, including SCADA, PLC’s. BAS, Data Historian, MES, and process control systems within a GMP manufacturing environment.
• Familiarity with regulatory requirements, such as FDA guidelines for GMP and data integrity, and the ability to ensure compliance within the operational technology domain.
• Understanding of cybersecurity principles and best practices as they apply to operational technology systems.
• Prior experience with business analysis and requirement gathering techniques.