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.

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.

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.

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.

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.

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.

Investigate and resolve OT incidents within agreed SLAs.

Execute change management activities following approved SOPs.

Perform impact and risk assessments before implementing changes.

Plan and execute preventive maintenance for OT hardware and software.

Monitor system performance and recommend improvements.

Maintain software versions and firmware updates.

Participate in implementation of new OT projects.

Support FAT, SAT, commissioning, qualification, and system handover.

Coordinate with vendors during installation and troubleshooting.

Prepare and maintain:

• SOPs
• Work Instructions
• Configuration Documents
• Validation Documents
• Backup & Recovery Procedures
• Network Diagrams
• Disaster Recovery Documentation

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.

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.

Train end users on OT applications and system usage.

Develop user manuals and technical documentation.

Mentor junior OT engineers and executives.

• GAMP 5
• 21 CFR Part 11
• EU Annex 11
• ALCOA+ Data Integrity
• SCADA, DCS, PLC, HMI
• MES, EMS, BMS
• LIMS, Empower, Chromeleon, Lab Solutions, 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
• Computer System Validation (CSV)
• Strong analytical and troubleshooting skills
• Knowledge of pharmaceutical GxP regulations
• Project coordination and execution
• Cross-functional collaboration
• Technical documentation and report writing