OT Engineer
About The Position
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.
Requirements
- Bachelors Degree
- 5 years of relevant experience
Nice To Haves
- Pharma/GMP Experience is preferred
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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
