The OT Systems Engineer supports the design, implementation, and maintenance of Operational Technology (OT) systems at a regulated pharmaceutical oral solid dose (OSD) manufacturing site. This includes PLCs, HMIs, SCADA, BAS/BMS, data historians, LIMS, LMS, and automation interfaces across manufacturing, packaging, utilities, and laboratories.
This role ensures system reliability, cybersecurity, and GMP compliance through robust design, troubleshooting, user administration, and backup/recovery strategies. The engineer also supports Computer System Validation (CSV) activities in alignment with 21 CFR Part 11 and GAMP 5, maintaining validated backup libraries to ensure business continuity and data integrity.
Key Responsibilities:
System Ownership & Lifecycle Management
Manage OT systems (PLCs, HMIs, SCADA, BAS/BMS, LIMS/LMS), ensuring compliance with GAMP and 21 CFR Part 11, and maintain architecture, configuration, and asset documentation.
Backup, Restoration & Disaster Recovery
Maintain validated backups and perform restoration testing for all OT platforms to ensure disaster recovery readiness and compliance.
Project Execution & System Integration
Lead OT scope in equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation in collaboration with Engineering and IT.
Lab Automation & Analytical Systems Support
Integrate lab instruments with OT infrastructure and troubleshoot automated lab workflows, maintaining documentation and backups.
Troubleshooting & Cross-Functional Support
Provide advanced troubleshooting for automation faults and network issues, working with Engineering, QC, Maintenance, and IT to resolve problems.
Cybersecurity & Compliance Oversight
Implement OT cybersecurity controls, manage user access and patching, and support audits with validation and compliance documentation.
Documentation, Collaboration & Continuous Improvement
Author SOPs and validation documents, support cross-functional initiatives, and drive automation optimization and digital transformation efforts.
Key Qualifications:
