Lead Automation Engineer

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff. Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to join the team and shape the future of AstraZeneca Operations.

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.

Responsibilities

• Technical ownership: Serve as the automation technical lead for assigned capital projects, process improvements, technology transfers, equipment installations, and control system lifecycle initiatives.
• Control system design: 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.
• DeltaV systems: 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.
• Rockwell and FactoryTalk systems: 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.
• Small upgrades and modifications: 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.

• Technical ownership: Serve as the automation technical lead for assigned capital projects, process improvements, technology transfers, equipment installations, and control system lifecycle initiatives.
• Control system design: 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.
• DeltaV systems: 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.
• Rockwell and FactoryTalk systems: 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.
• Small upgrades and modifications: 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.
• Systems integration: 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.
• Standards and architecture: 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.
• Lifecycle management: 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.

Capital Project Delivery

• Project leadership: 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.
• Project planning: Define automation scope, deliverables, resource requirements, schedules, cost estimates, risks, assumptions, interfaces, and execution strategies.
• Design reviews: Lead or participate in design reviews, including process automation, instrumentation, electrical, network, cybersecurity, data integrity, maintainability, operability, and safety reviews.
• Vendor and contractor management: 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.
• Equipment integration: Ensure that skids, process equipment, utilities, packaging systems, and other automated assets are appropriately integrated into the site control architecture and operational model.
• Project interfaces: Coordinate automation interfaces with Process Engineering, Manufacturing, Facilities, Quality, Validation, IT/OT, EHS, Supply Chain, and other project disciplines.
• Capital governance: Provide automation input to project estimates, schedules, change requests, risk registers, procurement decisions, design reviews, stage gates, and management reporting.

Commissioning, Qualification, and Validation

• Testing strategy: Develop and approve automation test strategies, test plans, Factory Acceptance Test protocols, Site Acceptance Test protocols, commissioning plans, and qualification documentation.
• FAT and SAT execution: 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.
• Validation support: Provide automation subject-matter expertise for commissioning, qualification, computerized system validation, and computer software assurance activities, and requirements traceability.
• Requirements traceability: Ensure that user requirements, functional requirements, design specifications, risk assessments, test cases, deviations, and acceptance criteria are complete and appropriately linked.
• Defect management: Manage test discrepancies, punch-list items, deviations, and corrective actions through documented resolution and approval.
• Handover: Ensure that automation systems are transferred to site operations with complete documentation, training, backups, licenses, source code, spare parts, maintenance procedures, and support arrangements.

Manufacturing Support and Troubleshooting

• Operational support: 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.
• Root-cause investigations: Lead troubleshooting and investigations involving control system software, instrumentation, networks, equipment interfaces, sequences, alarms, batch execution, data collection, and operator interaction.
• Deviation and CAPA support: Support or lead automation-related deviation investigations, root-cause analyses, corrective and preventive actions, change controls, and effectiveness checks.
• Reliability improvement: Identify recurring failure modes and implement improvements to increase system availability, reduce unplanned downtime, improve alarm performance, and strengthen operational resilience.
• On-call escalation: Participate in the site automation support rotation and provide timely escalation support for critical control system, process monitoring, or network issues.
• Field support: 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.

Compliance, Data Integrity, and Cybersecurity

• cGMP compliance: Ensure automation activities are executed in accordance with applicable cGMP requirements, site procedures, quality systems, engineering standards, and approved change control processes.
• GAMP and assurance practices: Apply risk-based approaches consistent with GAMP 5, computer software assurance principles, lifecycle management, and site validation procedures.
• Data integrity: 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.
• Cybersecurity: 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.
• Audit and inspection support: Provide technical support during internal audits, customer audits, regulatory inspections, and quality reviews. Clearly explain automation systems, controls, testing, data flows, and lifecycle practices.
• Documentation control: Maintain accurate and current system specifications, drawings, source-code records, software inventories, network documentation, operating procedures, test records, and engineering files.

People and Functional Leadership

• Team leadership: Lead cross-functional automation teams and provide technical direction to Automation technicians, contractors, consultants, and system integrators.
• Coaching and mentoring: Train and mentor technicians in DeltaV, Rockwell, FactoryTalk, instrumentation, control-loop programming, troubleshooting, validation, project execution, and regulated manufacturing practices.
• Technical assessment: Review engineering work products, assess technical risks, challenge assumptions, and ensure that solutions are robust, maintainable, and compliant.
• Knowledge management: Develop and maintain training materials, standard work, programming guidelines, troubleshooting guides, lessons learned, and site automation curricula.
• Resource planning: Provide input to staffing plans, contractor requirements, skills matrices, succession planning, and development priorities for the automation function.
• Stakeholder management: Build effective relationships across a matrix organization and communicate complex technical issues clearly to both technical and nontechnical stakeholders.

Continuous Improvement and Strategic Development

• Continuous improvement: Identify and implement improvements to control strategies, batch performance, alarm management, operator interfaces, system reliability, data visibility, and engineering work processes.
• Technology evaluation: Evaluate emerging automation, digital manufacturing, data analytics, MES, cloud, virtualization, and industrial networking technologies for potential application at the site.
• Standardization: Promote consistent automation designs and reusable solutions across projects, production areas, and manufacturing systems.
• Asset lifecycle management: Serve as a technical contributor to asset lifecycle planning, obsolescence management, reliability-centered maintenance, and long-term automation roadmaps.
• Digital integration: Support the convergence of OT, IT, MES, historians, analytics, and enterprise systems while maintaining appropriate reliability, cybersecurity, data integrity, and compliance controls.

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

• Leader Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Minimum 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.

Desired Qualifications

• 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.

The annual base pay (or hourly rate of compensation) for this position ranges from $108,194.40 to $162,291.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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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.