OT Engineer

Lonza•Tampa, FL

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. Systems include PLCs, HMIs, SCADA, BAS/BMS, data historians, LIMS, LMS, and automation interfaces across manufacturing, packaging, utilities, and laboratories. The role ensures system reliability, cybersecurity, and GMP compliance through robust design, troubleshooting, user administration, and backup and recovery strategies. It also supports Computer System Validation (CSV) activities aligned with 21 CFR Part 11 and GAMP 5, maintaining validated backup libraries to support business continuity and data integrity.

Requirements

  • Bachelor's degree.
  • Five years of relevant experience.

Nice To Haves

  • Pharma/GMP experience.

Responsibilities

  • Manage OT systems, including PLCs, HMIs, SCADA, BAS/BMS, LIMS, and LMS, ensuring compliance with GAMP and 21 CFR Part 11 and maintaining architecture, configuration, and asset documentation.
  • Maintain validated backups and perform restoration testing for OT platforms to ensure disaster recovery readiness and compliance.
  • Lead OT scope in equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation in collaboration with Engineering and IT.
  • Integrate laboratory instruments with OT infrastructure and troubleshoot automated laboratory workflows, maintaining documentation and backups.
  • Provide advanced troubleshooting for automation faults and network issues, working with Engineering, QC, Maintenance, and IT to resolve problems.
  • Implement OT cybersecurity controls, manage user access and patching, and support audits with validation and compliance documentation.
  • Author SOPs and validation documents, support cross-functional initiatives, and drive automation optimization and digital transformation efforts.
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