Lead Automation Engineer

AstraZeneca•Frederick, MD

22h•$108,194 - $162,292

About The Position

The Lead Automation Engineer provides technical leadership for automation engineering activities at AstraZeneca’s Frederick Manufacturing Center, a biopharmaceutical manufacturing facility with more than 800 employees. The role supports capital projects, technology transfers, lifecycle management, continuous improvement, and small-to-medium control system upgrades. It is accountable for the design, integration, implementation, commissioning, validation, and ongoing technical support of process control and automation systems, primarily Emerson DeltaV DCS and Rockwell Automation PLC/FactoryTalk systems. The position acts as an automation technical authority across Engineering, Manufacturing, Quality, Process Development, Facilities, IT/OT, Validation, and external engineering partners. It leads automation scope for capital projects and provides hands-on support for system modifications, troubleshooting, software and hardware changes, upgrades, control strategy improvements, alarm management, data integration, and obsolescence activities. The role also provides technical direction, coaching, and mentoring to Automation Engineers, contractors, system integrators, and project teams, and may participate in an on-call or escalation rotation for continuous manufacturing operations. The Lead Automation Engineer ensures that automation solutions are safe, reliable, maintainable, scalable, compliant with cGMP requirements, and aligned with site and enterprise standards. The role supports commissioning, qualification, validation, manufacturing operations, compliance, data integrity, cybersecurity, and continuous improvement, while contributing to team and functional leadership.

Requirements

Bachelor’s degree in engineering from an accredited institution, preferably Electrical Engineering, Control Systems Engineering, Instrumentation Engineering, Automation Engineering, Chemical Engineering, Computer Engineering, or a closely related discipline; the posting also lists alternative education and work-experience pathways.
At least 8 years of experience implementing automation solutions in an industrial environment.
Demonstrated experience leading automation engineering activities in biopharmaceutical, pharmaceutical, biotechnology, or other highly regulated manufacturing.
Advanced understanding of DeltaV architecture, configuration, control and equipment modules, phases, batch execution, recipes, graphics, alarms, historian interfaces, security, and upgrades.
Advanced working knowledge of Allen-Bradley ControlLogix or CompactLogix PLCs, Studio 5000, FactoryTalk View and services, HMI applications, communication interfaces, and troubleshooting.
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 communications 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.
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 and 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 in a commercial biopharmaceutical manufacturing facility with exposure to manufacturing, process or 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 HMI 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, specifications, instrument indexes, I/O assignments, network diagrams, alarm philosophies, and control strategies.
Lead design, configuration, programming, testing, commissioning, troubleshooting, and lifecycle management of Emerson DeltaV DCS applications.
Lead or provide technical oversight for Rockwell PLC and FactoryTalk applications, including ControlLogix and CompactLogix platforms, HMI applications, networks, safety systems, VFD interfaces, and packaged equipment integrations.
Independently scope and execute control system changes, upgrades, equipment integrations, and obsolescence replacements.
Integrate 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 documentation.
Evaluate automation system health, reliability, capacity, maintainability, cybersecurity, vendor support, and obsolescence; develop lifecycle strategies for upgrades, migrations, backups, disaster recovery, spares, and replacements.
Lead automation engineering scope for capital projects from concept and feasibility through design, procurement, construction, commissioning, qualification, handover, and closeout.
Define automation scope, deliverables, resource requirements, schedules, cost estimates, risks, assumptions, interfaces, and execution strategies.
Lead or participate in design reviews covering automation, instrumentation, electrical, network, cybersecurity, data integrity, maintainability, operability, and safety.
Provide technical direction to system integrators, automation vendors, EPC contractors, equipment manufacturers, and commissioning organizations; review their deliverables.
Coordinate automation interfaces with project disciplines and ensure equipment is integrated with the site control architecture and operational model.
Provide automation input to project estimates, schedules, change requests, risk registers, procurement decisions, stage gates, and management reporting.
Develop and approve automation test strategies, test plans, FAT and SAT protocols, commissioning plans, and qualification documentation.
Lead or support FAT, SAT, loop checks, I/O verification, functional and sequence testing, alarm and interlock testing, communications testing, failure-mode testing, and performance testing.
Provide subject-matter expertise for commissioning, qualification, computerized system validation, computer software assurance, and requirements traceability.
Ensure user requirements, functional requirements, design specifications, risk assessments, test cases, deviations, and acceptance criteria are complete and linked appropriately.
Manage test discrepancies, punch-list items, deviations, and corrective actions through documented resolution and approval.
Ensure automation systems are handed over 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 issues affecting performance, availability, product quality, or compliance.
Lead troubleshooting and investigations involving control software, instrumentation, networks, equipment interfaces, sequences, alarms, batch execution, data collection, and operator interaction.
Support or lead automation-related deviation investigations, root-cause analyses, CAPAs, change controls, and effectiveness checks.
Identify recurring failure modes and implement improvements to system availability, downtime, alarm performance, and 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 confirm installed systems match approved documentation.
Ensure automation activities comply with cGMP requirements, site procedures, quality systems, engineering standards, and approved change-control processes.
Apply risk-based GAMP 5, computer software assurance, lifecycle management, and site validation practices.
Ensure electronic records, audit trails, alarms, batch records, historian data, user access, time synchronization, backups, and data interfaces support data integrity expectations.
Apply 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 and customer audits, regulatory inspections, and quality reviews.
Maintain accurate system specifications, drawings, source-code records, software inventories, network documentation, procedures, test records, and engineering files.
Lead cross-functional automation teams and provide technical direction to technicians, contractors, consultants, and system integrators.
Train and mentor technicians in automation systems, instrumentation, control-loop programming, troubleshooting, validation, project execution, and regulated manufacturing practices.
Review engineering work products, assess technical risks, challenge assumptions, and ensure solutions are robust, maintainable, and compliant.
Develop and maintain training materials, standard work, programming guidelines, troubleshooting guides, lessons learned, and automation curricula.
Provide input to staffing plans, contractor requirements, skills matrices, succession planning, and development priorities.
Build relationships across a matrix organization and communicate technical issues to technical and nontechnical stakeholders.
Identify and implement improvements to control strategies, batch performance, alarm management, operator interfaces, reliability, data visibility, and engineering work processes.
Evaluate emerging automation, digital manufacturing, data analytics, MES, cloud, virtualization, and industrial networking technologies.
Promote consistent automation designs and reusable solutions across projects, production areas, and manufacturing systems.
Contribute to asset lifecycle planning, obsolescence management, reliability-centered maintenance, and long-term automation roadmaps.
Support OT/IT, MES, historian, analytics, and enterprise system integration while maintaining reliability, cybersecurity, data integrity, and compliance controls.
Conduct activities in accordance with Company values, the Code of Conduct, and applicable policies and standards; complete required training and report potential non-compliance.
Promote compliance by team members and third parties, support a culture where concerns can be raised, ensure required training is completed, and address or report non-compliance.
Meet leader accountabilities for ethical conduct and compliance, team and performance management, development planning, talent management, recruitment, people information, SHE, and fiscal and financial awareness.
For GXP areas, understand applicable legal and regulatory requirements and provide appropriate resources to maintain and continually improve the Quality system.