OT Systems Administration
Title: OT Systems AdministrationLocation: NJAdminister 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.2. 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.3. GxP ComplianceEnsure 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.4. User & Security AdministrationManage 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.5. Network & Infrastructure ManagementSupport 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.6. Automation & Equipment SupportSupport 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.7. Incident & Change ManagementInvestigate and resolve OT incidents within agreed SLAs.Execute change management activities following approved SOPs.Perform impact and risk assessments before implementing changes.8. Preventive MaintenancePlan and execute preventive maintenance for OT hardware and software.Monitor system performance and recommend improvements.Maintain software versions and firmware updates.9. Project ExecutionParticipate in implementation of new OT projects.Support FAT, SAT, commissioning, qualification, and system handover.Coordinate with vendors during installation and troubleshooting.10. Documentation ManagementPrepare and maintain:SOPsWork InstructionsConfiguration DocumentsValidation DocumentsBackup & Recovery ProceduresNetwork DiagramsAsset InventoryDisaster Recovery Documentation11. Vendor & Stakeholder CoordinationCoordinate 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.12. Audit SupportSupport 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.13. Training & Knowledge SharingTrain end users on OT applications and system usage.Develop user manuals and technical documentation.Mentor junior OT engineers and executives.Required Technical SkillsGAMP 521 CFR Part 11EU Annex 11ALCOA+ Data IntegritySCADA, DCS, PLC, HMIMES, EMS, BMSLIMS, Empower, Chromeleon, LabSolutions, Analyst, Tiamo, OMNISWindows Server AdministrationActive DirectoryVMware/Hyper-VSQL Server/Oracle DatabaseTCP/IP Networking, VLANsFirewall & Switch ConfigurationBackup & Disaster RecoveryOT CybersecurityChange Control & Incident ManagementComputer System Validation (CSV)Key CompetenciesStrong analytical and troubleshooting skillsKnowledge of pharmaceutical GxP regulationsProject coordination and executionCross-functional collaborationTechnical documentation and report writingTime management and prioritizationVendor managementCommunication and presentation skillsContinuous improvement mindset