Senior Operational Technology

Senior Operational Technology (OT) Executive – Roles & Responsibilities (Pharmaceutical Industry) Job Summary The Senior OT Executive is responsible for managing and supporting Operational Technology (OT) systems, industrial automation, GxP computerized systems, and IT/OT infrastructure to ensure reliable, secure, and compliant operations in pharmaceutical manufacturing, laboratories, and utilities. Key Roles & Responsibilities: 1. OT Systems Administration • Administer and maintain OT systems, including SCADA, DCS, PLC, HMI, Historian, MES, BMS, EMS, and laboratory computerized systems. • Ensure high availability and reliability of OT applications. • Monitor system health and resolve operational issues. 1. Computer System Validation (CSV) • Execute and maintain Computer System Validation (CSV) activities in accordance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles. • Prepare and review Validation Plans, Risk Assessments, IQ, OQ, PQ, RTM, VSR, and periodic review documentation. • Support validation during new system implementation, upgrades, and changes. 1. GxP Compliance • Ensure all OT systems comply with regulatory requirements and internal quality procedures. • Support data integrity initiatives and electronic records/electronic signatures compliance. • Participate in regulatory inspections and customer audits. 1. User & Security Administration • Manage user accounts, roles, permissions, and security policies. • Perform periodic user access reviews. • Configure password policies, audit trails, and account management. • Maintain system activity logs and security documentation. 1. Network & Infrastructure Management • Support OT network infrastructure, including industrial switches, routers, firewalls, VLANs, and managed networks. • Coordinate with IT teams for network connectivity and cybersecurity. • Perform backup, restoration, and disaster recovery activities. 1. Automation & Equipment Support • Support automation systems connected to manufacturing and laboratory equipment. • Coordinate with Engineering and Instrumentation teams during equipment installation, qualification, and commissioning. • Troubleshoot hardware and software issues. 1. Incident & Change Management • Investigate and resolve OT incidents within agreed SLAs. • Execute change management activities following approved SOPs. • Perform impact and risk assessments before implementing changes. 1. Preventive Maintenance • Plan and execute preventive maintenance for OT hardware and software. • Monitor system performance and recommend improvements. • Maintain software versions and firmware updates. 1. Project Execution • Participate in implementation of new OT projects. • Support FAT, SAT, commissioning, qualification, and system handover. • Coordinate with vendors during installation and troubleshooting. 1. Documentation Management Prepare and maintain: • SOPs • Work Instructions • Configuration Documents • Validation Documents • Backup & Recovery Procedures • Network Diagrams • Asset Inventory • Disaster Recovery Documentation 1. Vendor & Stakeholder Coordination • Coordinate with vendors for system support, AMC activities, and upgrades. • Work closely with QA, QC, Production, Engineering, Automation, and IT teams. • Track vendor deliverables and ensure timely issue resolution. 1. Audit Support • Support internal audits and regulatory inspections (US FDA, MHRA, EMA, WHO). • Provide validation records, configuration documents, and audit evidence. • Address audit observations and implement corrective actions. 1. Training & Knowledge Sharing • Train end users on OT applications and system usage. • Develop user manuals and technical documentation. • Mentor junior OT engineers and executives. Required Technical Skills: • GAMP 5 • 21 CFR Part 11 • EU Annex 11 • ALCOA+ Data Integrity • SCADA, DCS, PLC, HMI • MES, EMS, BMS • LIMS, Empower, Chromeleon, LabSolutions, Analyst, Tiamo, OMNIS • Windows Server Administration • Active Directory • VMware/Hyper-V • SQL Server/Oracle Database • TCP/IP Networking, VLANs • Firewall & Switch Configuration • Backup & Disaster Recovery • OT Cybersecurity • Change Control & Incident Management • Computer System Validation (CSV) Key Competencies: • Strong analytical and troubleshooting skills • Knowledge of pharmaceutical GxP regulations • Project coordination and execution • Cross-functional collaboration • Technical documentation and report writing • Time management and prioritization • Vendor management • Communication and presentation skills • Continuous improvement mindset