Plant OT Engineer – Manufacturing Applications

Plant OT Engineer – Manufacturing Applications

Location: Tampa, FL – Onsite
Industry: Pharmaceutical / Oral Solid Dose Manufacturing

Contract: 6+ months with strong potential to go contract to hire

Role Summary

Automated Systems, Inc. (ASI) is seeking an experienced Plant Operational Technology (OT) Engineer to provide site-level ownership, governance, and support for enterprise manufacturing applications at Lonza’s Tampa facility. This individual will serve as the primary liaison among Manufacturing, Engineering, Quality, IT, Global OT, system vendors, and business process owners to ensure critical plant applications remain reliable, secure, compliant, and fit for their intended use.

The Plant OT Engineer will oversee the full application lifecycle for the site’s Manufacturing Execution System (MES), computerized maintenance and calibration management systems, Building Management System (BMS), Laboratory Information Management System (LIMS), serialization systems, and associated interfaces. The role combines application ownership, project coordination, vendor management, GxP compliance, cybersecurity, system lifecycle planning, and operational support.

Key Responsibilities

• Manage site manufacturing applications, including MES, maintenance and calibration software, BMS, LIMS, and serialization systems.
  
• Serve as the primary site contact for application support, incidents, upgrades, integrations, and vendor coordination.
  
• Maintain system inventories, lifecycle plans, support documentation, licenses, and application roadmaps.
  
• Coordinate user access, system configuration, backups, disaster recovery, and business continuity.
  
• Manage application changes through approved change-control, testing, and validation processes.
  
• Ensure systems remain compliant with GxP, data-integrity, 21 CFR Part 11, and cybersecurity requirements.
  
• Support investigations, audits, regulatory inspections, and critical system recovery activities.
  
• Coordinate manufacturing equipment and business-system integrations.
  

Requirements

Qualifications

• Bachelor’s degree in Engineering, IT, Computer Science, Automation, or a related field.
  
• Five or more years of IT/OT application experience in pharmaceutical or regulated manufacturing.
  
• Experience with MES and several of the following: CMMS, calibration systems, BMS, LIMS, or serialization.
  
• Knowledge of computerized-system validation, change control, data integrity, and application lifecycle management.
  
• Strong troubleshooting, vendor-management, communication, and cross-functional leadership skills.
  
• Oral solid dose manufacturing experience is preferred.