Principal Automation Engineer

Principal Automation Engineer

The Principal Automation Engineer serves as a site Subject Matter Expert (SME) and technical authority for industrial process control systems within the Frederick Manufacturing Center with a focus on right first time delivery and on-time equipment startup, through the application of process control and automation engineering fundamentals. This role is responsible for the architecture, design, implementation, validation, and lifecycle management of process control systems to ensure compliance, reliability, and scalability.

This individual will provide strategic and hands-on leadership across automation platforms, ensuring systems meet regulatory expectations (FDA, EMA), and support validated processes, and align with business and operational objectives. The role will lead complex automation initiatives, mentor engineering staff, and drive continuous improvement in control system performance, data integrity, and cybersecurity posture. The individual will partner with site engineering teams and customers to provide consultation and technical problem solving related to complex process controls including both Emerson DeltaV and Rockwell systems. They will also utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions.

Key Responsibilities

Technical Leadership & System Ownership

• Serve as the technical authority for distributed control systems (DCS) and PLC-based platforms, with primary ownership of:
  • Emerson DeltaV (including DeltaV Live)
  • Rockwell Automation RSLogix / Studio 5000
  • Rockewell FactoryTalk suite

• Work with department leadership to establish and govern automation engineering standards, including GMP-compliant design practices, documentation standards, and lifecycle management procedures.
• Lead control system lifecycle strategy including validation, periodic review, patching, upgrades, and obsolescence management.
• Ensure systems maintain data integrity and audit readiness at all times.

System Design, Programming & Implementation

• Architect and implement scalable, compliant automation solutions for bioprocessing systems (upstream, downstream, and utilities).
• Design and develop complex control strategies using ISA-88 (S88) batch control standards, including:
  • Modular and reusable equipment phases
  • Unit and equipment module design
  • Recipe management and procedural control

• Develop and maintain:
  • Functional Specifications (FS)
  • Design Specifications (DS/FDS)
  • Control Narratives
• Configure and program:
  • DeltaV control modules, equipment modules, and batch recipes
  • Rockwell PLC logic and HMI/SCADA applications
  • FactoryTalk applications and integrations

• Implement advanced HMI solutions using DeltaV Live and FactoryTalk View with a focus on operator usability and compliance.
• Possess technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement of self in automation hardware, software, and platforms

Troubleshooting & Operational Excellence

• Lead root cause investigations for process deviations, batch failures, and automation-related events.
• Provide advanced troubleshooting support across DCS, PLC, HMI, and integrated systems.
• Optimize control strategies to improve process robustness, batch consistency and yield.
• Act as the highest-level escalation point for automation issues impacting automation systems.

Project Leadership & Execution

• Lead automation scope for large or complex capital and department projects from concept through commissioning, qualification, and handover.
• Develop and manage detailed project plans, schedules, and resource allocations.
• Coordinate with cross-functional teams including Process Engineering, Validation, Quality, IT, and Manufacturing.
• Oversee and execute system integration, FAT, SAT, and site commissioning activities.

GMP Compliance & Computer System Validation (CSV)

• Ensure all automation systems are developed, implemented, and maintained in compliance with:
  • cGMP regulations (21 CFR Part 11, Annex 11)
  • GAMP 5 guidelines
  • Internal quality and validation standards
• Lead and author validation deliverables including:
  • User Requirements Specifications (URS)
  • Functional and Design Specifications (FDS/DS)
  • Risk Assessments (FMEA, System Risk Assessments)
  • IQ/OQ protocols and reports
• Ensure systems meet electronic records and electronic signature (ER/ES) requirements.
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