Lead Automation Engineer

AstraZeneca • Frederick, MD

1d • $108,194 - $162,292 • Onsite

About The Position

The Lead Automation Engineer provides technical leadership for automation engineering activities supporting capital projects, technology transfers, lifecycle management, continuous improvement, and small-to-medium control system upgrades at a biopharmaceutical manufacturing facility. The role is accountable for the design, integration, implementation, commissioning, validation, and ongoing technical support of process control and automation systems, with primary responsibility for Emerson DeltaV DCS and Rockwell Automation PLC/FactoryTalk systems. The Lead Automation Engineer serves as a automation technical authority across Engineering, Manufacturing, Quality, Process Development, Facilities, IT/OT, Validation, and external engineering partners. The role ensures that automation solutions are safe, reliable, maintainable, scalable, compliant with cGMP requirements, and aligned with site and enterprise automation standards. The position will lead automation scope for capital projects and provide hands-on engineering support for smaller system modifications, including troubleshooting, software and hardware changes, system upgrades, control strategy improvements, alarm management, data integration, and obsolescence-related activities. The role also provides technical direction, coaching, and mentoring to Automation Engineers, contractors, system integrators, and project teams. This position may participate in an on-call or escalation rotation to support continuous manufacturing operations.

Requirements

• High school diploma or equivalent or High school diploma or GED
• Bachelors degree, BA/BS degree
• Bachelors degree or 4 additional years of work experience in lieu of degree
• Associate degree or 2 additional years of work experience in lieu of a degree
• Bachelor’s degree in engineering from an accredited institution, preferably in Electrical Engineering, Control Systems Engineering, Instrumentation Engineering, Automation Engineering, Chemical Engineering, Computer Engineering, or a closely related discipline
• Minimum 8 years Expoerience implementing automation solutions in an industrial environment.
• Demonstrated experience leading automation engineering activities in a biopharmaceutical, pharmaceutical, biotechnology, or other highly regulated manufacturing environment.
• Advanced understanding of DeltaV system architecture, configuration, control modules, equipment modules, phases, batch execution, recipes, graphics, alarms, historian interfaces, system security, and system upgrades.
• Advanced working knowledge of Allen-Bradley ControlLogix or CompactLogix PLCs, Studio 5000, FactoryTalk View, FactoryTalk services, HMI applications, communication interfaces, and troubleshooting methods.
• Advanced understanding of instrumentation, control-loop programming, PID control, interlocks, permissives, sequencing, process dynamics, alarm management, and control strategy development.
• Working knowledge of ISA-88 principles, including recipes, procedural control, equipment modules, phases, unit procedures, operations, and batch exception handling.
• Knowledge of industrial communication protocols and interfaces such as OPC, Ethernet/IP, Modbus TCP/IP, serial communications, and vendor-specific equipment interfaces.
• Ability to interpret and develop control system architectures, network diagrams, I/O drawings, cabinet layouts, loop diagrams, P&IDs, cause-and-effect matrices, and electrical or instrumentation documentation.
• Strong problem-solving skills using structured methods such as root-cause analysis, five-whys, fault-tree analysis, risk assessment, failure-mode analysis, and practical problem solving.
• Ability to lead automation scope for capital projects from conceptual design through commissioning, qualification, startup, and operational handover. Experience executing or overseeing control system upgrades, modifications, troubleshooting, and lifecycle management activities.
• Experience working within formal change control, deviation, CAPA, commissioning, qualification, validation, or computer software assurance processes.
• Ability to lead cross-functional teams and manage technical interfaces with Engineering, Manufacturing, Quality, Validation, IT/OT, Facilities, vendors, and contractors.
• Ability to work independently, prioritize competing demands, make sound technical decisions, and appropriately escalate safety, quality, compliance, schedule, or cost risks.
• Willingness and ability to provide occasional off-hours, weekend, or on-call support for manufacturing operations.

Nice To Haves

• Advanced degree in engineering, automation, process control, computer science, industrial information technology, or a related technical discipline.
• Formal training or certification in Emerson DeltaV, Rockwell Automation, FactoryTalk, ISA-88, ISA-95, ISA-101, ISA-18.2, project management, validation, or OT cybersecurity.
• Project management certification such as PMP or equivalent demonstrated project management training
• Working knowledge of cGMP, GAMP 5, computer software assurance, electronic records, electronic signatures, audit trails, data integrity, change control, deviation management, and CAPA.
• Working knowledge of industrial control system cybersecurity, access management, backups, disaster recovery, system hardening, network segmentation, patching, remote access, and applicable ISA/IEC 62443 concepts.
• Experience working in a commercial biopharmaceutical manufacturing facility with direct exposure to manufacturing, process utilities, clean utilities, upstream or downstream processing, formulation, fill-finish, packaging, or laboratory support systems.
• Experience supporting regulatory inspections and customer or corporate audits.
• Experience with computerized maintenance management systems, enterprise resource planning systems, electronic batch records, or manufacturing execution systems.
• Experience developing automation standards, reusable code libraries, site templates, engineering procedures, or departmental tools.
• Experience managing large automation vendors, EPC organizations, system integrators, and technical service providers.
• Experience with process historians, data collection, contextualization, dashboards, advanced analytics, or manufacturing performance monitoring.
• In-depth understanding of ISA-88 batch design, recipe management, exception handling, batch reporting, and batch optimization.
• Experience applying ISA-18.2 principles, alarm rationalization, alarm shelving, alarm performance monitoring, and operator response design.
• Experience applying ISA-101 principles to human-machine interface design, graphics standards, navigation, situational awareness, and operator usability.

Responsibilities

• Serve as the automation technical lead for assigned capital projects, process improvements, technology transfers, equipment installations, and control system lifecycle initiatives.
• Develop, review, and approve automation concepts, system architectures, control narratives, functional specifications, software design specifications, instrument indexes, I/O assignments, network diagrams, alarm philosophies, and control strategies.
• Lead the design, configuration, programming, testing, commissioning, troubleshooting, and lifecycle management of Emerson DeltaV DCS applications, including control modules, equipment modules, phases, unit procedures, recipes, graphics, alarms, historian interfaces, batch functionality, and system infrastructure.
• Lead or provide technical oversight for Rockwell PLC and FactoryTalk applications, including ControlLogix and CompactLogix platforms, FactoryTalk View, FactoryTalk Batch where applicable, HMI applications, communication networks, safety systems, VFD interfaces, and packaged equipment integrations.
• Independently scope and execute control system changes such as recipe updates, sequence modifications, alarm changes, HMI enhancements, instrumentation changes, equipment integrations, software upgrades, reports, historian tags, network changes, and obsolescence replacements.
• Ensure effective integration among DeltaV, Rockwell PLCs, FactoryTalk applications, MES/electronic batch record systems, historians, building management systems, laboratory systems, enterprise applications, and third-party equipment.
• Establish and maintain site automation standards for hardware, software, programming, graphics, alarm management, batch configuration, networking, cybersecurity, naming conventions, source-code management, and system documentation.
• Evaluate system health, reliability, capacity, maintainability, cybersecurity, vendor support, and obsolescence. Develop and implement lifecycle strategies, including upgrades, migrations, backups, disaster recovery, spares, and replacement plans.
• Lead automation engineering scope for small-to-large capital projects from concept development and feasibility through design, procurement, construction, commissioning, qualification, operational handover, and closeout.
• Define automation scope, deliverables, resource requirements, schedules, cost estimates, risks, assumptions, interfaces, and execution strategies.
• Lead or participate in design reviews, including process automation, instrumentation, electrical, network, cybersecurity, data integrity, maintainability, operability, and safety reviews.
• Provide technical direction to system integrators, automation vendors, EPC contractors, equipment manufacturers, and commissioning organizations. Review deliverables for technical quality, compliance, completeness, and alignment with site standards.
• Ensure that skids, process equipment, utilities, packaging systems, and other automated assets are appropriately integrated into the site control architecture and operational model.
• Provide automation input to project estimates, schedules, change requests, risk registers, procurement decisions, design reviews, stage gates, and management reporting.
• Develop and approve automation test strategies, test plans, Factory Acceptance Test protocols, Site Acceptance Test protocols, commissioning plans, and qualification documentation.
• Lead or support FAT, SAT, loop checks, I/O verification, functional testing, sequence testing, alarm testing, interlock testing, communications testing, failure-mode testing, and performance testing.
• Provide automation subject-matter expertise for commissioning, qualification, computerized system validation, and computer software assurance activities, and requirements traceability.
• Ensure that user requirements, functional requirements, design specifications, risk assessments, test cases, deviations, and acceptance criteria are complete and appropriately linked.
• Manage test discrepancies, punch-list items, deviations, and corrective actions through documented resolution and approval.
• Ensure that automation systems are transferred to site operations with complete documentation, training, backups, licenses, source code, spare parts, maintenance procedures, and support arrangements.
• Provide technical support to Manufacturing, Facilities, Process Engineering, Quality Control, and Maintenance for automation-related issues affecting process performance, equipment availability, product quality, or compliance.
• Lead troubleshooting and investigations involving control system software, instrumentation, networks, equipment interfaces, sequences, alarms, batch execution, data collection, and operator interaction.
• Support or lead automation-related deviation investigations, root-cause analyses, corrective and preventive actions, change controls, and effectiveness checks.
• Identify recurring failure modes and implement improvements to increase system availability, reduce unplanned downtime, improve alarm performance, and strengthen operational resilience.
• Participate in the site automation support rotation and provide timely escalation support for critical control system, process monitoring, or network issues.
• Conduct field walkdowns, verify instrument and equipment conditions, support loop checks, assess control panels and cabinets, and validate that installed systems match approved engineering documentation.
• Ensure automation activities are executed in accordance with applicable cGMP requirements, site procedures, quality systems, engineering standards, and approved change control processes.
• Apply risk-based approaches consistent with GAMP 5, computer software assurance principles, lifecycle management, and site validation procedures.
• Ensure that electronic records, audit trails, alarms, batch records, historian data, user access, system time synchronization, backups, and data interfaces support applicable data integrity expectations.
• Apply applicable OT cybersecurity requirements, including secure architecture, account management, patching, backup and recovery, network segmentation, remote access controls, antivirus or application allowlisting, and change governance.
• Provide technical support during internal audits, customer audits, regulatory inspections, and quality reviews. Clearly explain automation systems, controls, testing, data flows, and lifecycle practices.
• Maintain accurate and current system specifications, drawings, source-code records, software inventories, network documentation, operating procedures, test records, and engineering files.
• Lead cross-functional automation teams and provide technical direction to Automation technicians, contractors, consultants, and system integrators.
• Train and mentor technicians in DeltaV, Rockwell, FactoryTalk, instrumentation, control-loop programming, troubleshooting, validation, project execution, and regulated manufacturing practices.
• Review engineering work products, assess technical risks, challenge assumptions, and ensure that solutions are robust, maintainable, and compliant.
• Develop and maintain training materials, standard work, programming guidelines, troubleshooting guides, lessons learned, and site automation curricula.
• Provide input to staffing plans, contractor requirements, skills matrices, succession planning, and development priorities for the automation function.
• Build effective relationships across a matrix organization and communicate complex technical issues clearly to both technical and nontechnical stakeholders.
• Identify and implement improvements to control strategies, batch performance, alarm management, operator interfaces, system reliability, data visibility, and engineering work processes.
• Evaluate emerging automation, digital manufacturing, data analytics, MES, cloud, virtualization, and industrial networking technologies for potential application at the site.
• Promote consistent automation designs and reusable solutions across projects, production areas, and manufacturing systems.
• Serve as a technical contributor to asset lifecycle planning, obsolescence management, reliability-centered maintenance, and long-term automation roadmaps.
• Support the convergence of OT, IT, MES, historians, analytics, and enterprise systems while maintaining appropriate reliability, cybersecurity, data integrity, and compliance controls.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior