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.
• Support and lead:
  • Change control processes
  • Deviation investigations
  • CAPA implementation
  • Audit and inspection readiness activities
• Partner with Quality and Validation teams to ensure a risk-based validation approach is consistently applied.

Continuous Improvement & Digital Innovation

• Drive continuous improvement initiatives focused on automation reliability, maintainability, and standardization.
• Identify and implement opportunities for digital transformation, including data integration, advanced analytics, and system harmonization.
• Champion standardization of control strategies, code libraries, and engineering workflows across platforms.

Leadership/ Stakeholder Engagement

• Provide technical leadership and mentorship to automation engineers to think differently and build new skills.
• Build trusted relationships with internal and external stakeholders to co-create solutions, adapt quickly to changing priorities, and foster a culture of experimentation
• Lead and oversee contractors, system integrators, and external partners.
• Influence site and organizational strategy related to automation, validation, and digital manufacturing.

Basic Qualifications

• Bachelor’s degree in Engineering (Electrical, Chemical, Mechanical, Computer Engineering, or related discipline) required.
• Minimum 10 years of experience developing, designing, and troubleshooting industrial control systems. With significant experience developing systems from concept phase.
• Demonstrated expertise in:
  • DeltaV (including DeltaV Live)
  • Rockwell Automation RSLogix / Studio 5000
  • FactoryTalk suite
• Minimum 5+ years of experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment.

• Advanced proficiency in:
  • Control system architecture and design
  • PLC and DCS programming
  • HMI/SCADA development
  • Batch automation and recipe management
• Expert-level knowledge and application of ISA-88 (S88) standards, including modular design and batch execution frameworks.
• Strong experience with:
  • Computer System Validation (CSV) methodologies
  • Data integrity and regulatory compliance requirements
  • Industrial communication protocols (EtherNet/IP, OPC, Modbus)
  • Alarm management and system performance monitoring
• Proven ability to:
  • Develop and maintain GMP-compliant documentation
  • Execute complex troubleshooting and root cause analysis
  • Integrate automation systems across multiple automation platforms

Key Competencies

• Strategic mindset with strong execution focus
• Deep technical and engineering expertise with the ability to influence at all levels
• Advanced analytical and problem-solving capabilities
• Strong communication skills across technical, quality, and executive stakeholders
• High attention to detail in regulated environments
• Rapidly adapt to shifting priorities while maintaining a strong focus on user needs and business outcomes

The annual base pay (or hourly rate of compensation) for this position ranges from $138,771 - $208,156 USD Annual.  Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coveragein accordance withthe terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.