Sr. Engineer II, Drug Product Automation

The Role: Reporting to the Director, Global Drug Product Automation, the Sr. Engineer II, Drug Product will serve as a technical leader responsible for defining, governing, and advancing the automation and control system architecture supporting Drug Product Filling, Packaging, Visual Inspection, and related digital systems. The Principal Automation Engineer will provide technical leadership throughout the automation system lifecycle, including design, development, integration, startup, qualification, operational support, and continuous improvement. This individual will establish engineering standards and reusable design approaches, enable interoperability between equipment and digital platforms, and provide subject matter expertise for complex technical decisions, capital projects, system upgrades, and regulatory activities. Here’s What You’ll Do: Serve as a senior technical authority for Drug Product automation systems supporting Filling, Packaging, Visual Inspection, and associated manufacturing equipment. Define, develop, and evolve automation architecture and engineering standards for Drug Product equipment and digital systems, ensuring solutions are scalable, maintainable, modular, and aligned with current and future manufacturing requirements. Establish and govern automation standards for equipment state models, data structures, sequencing strategies, equipment modules, parameter frameworks, alarm management, and system integration patterns. Develop reusable and testable automation designs based on industry-recognized principles and standards, including ISA-88 and ISA-95. Provide technical governance and leadership for capital projects, equipment implementations, system upgrades, and vendor-developed automation solutions from concept and design through startup and qualification. Lead and participate in automation design reviews, including system architecture reviews, software design reviews, Factory Acceptance Testing, Site Acceptance Testing, HAZOPs, model reviews, and other engineering and safety assessments. Develop and maintain automation software, hardware, functional, and system architecture specifications to ensure designs meet manufacturing, quality, engineering, cybersecurity, and lifecycle requirements. Act as a system owner for GxP manufacturing systems, including Rockwell and Siemens PLC platforms, SCADA systems including AVEVA Wonderware, historians, equipment control systems, and associated automation engineering infrastructure. Define integration strategies that enable reliable communication and interoperability between equipment control systems, SCADA, MES, historians, serialization systems, data platforms, and enterprise applications. Establish requirements and standards for contextualized equipment data, OEE structures, alarm and event architectures, equipment data models, and system-to-system integration pathways. Partner with Manufacturing, MS&T, Engineering, Quality, IT Infrastructure, Digital, and automation vendors to ensure consistent implementation of automation strategies and standards. Provide technical leadership and mentorship to automation engineers across projects and manufacturing sites, driving harmonization of automation philosophies, design practices, and engineering execution. Support site automation teams with complex troubleshooting, root cause investigations, system performance issues, and implementation of sustainable corrective and preventive solutions. Ensure appropriate change control, configuration management, system lifecycle, and validation practices are incorporated into automation-related changes in accordance with GMP requirements. Serve as an automation subject matter expert during regulatory audits and inspections, providing technical support related to control system design, automation architecture, system lifecycle management, and data integrity. Identify and lead continuous improvement opportunities to improve equipment reliability, automation system performance, maintainability, data quality, and manufacturing efficiency. Stay current with advancements in industrial automation, digital manufacturing, control system architecture, and pharmaceutical manufacturing technologies and translate relevant developments into practical engineering standards and solutions. Provide technical training, coaching, and knowledge transfer to automation, engineering, manufacturing, and support personnel. Manage and influence multiple complex technical initiatives simultaneously, including coordination with internal stakeholders, equipment vendors, system integrators, and external partners. Use AI in an innovative manner to streamline Automation way of working. May require off-hours support for critical manufacturing or project activities as appropriate. Here’s What You’ll Need (Basic Qualifications) Bachelor’s Degree in Electrical Engineering, Mechanical Engineering, Computer Science, Automation Engineering, or a related technical field. Minimum of 6 years of experience in automation, controls engineering, or industrial digital systems within pharmaceutical, biotechnology, or advanced manufacturing environments. Significant experience supporting automation systems associated with Drug Product Filling and/or Packaging operations. Deep technical expertise with Rockwell and/or Siemens PLC and industrial control system platforms. Strong experience with SCADA and HMI platforms such as AVEVA System Platform/Wonderware, FactoryTalk or similar industrial visualization platforms. Strong understanding of ISA-88 and ISA-95 concepts and their application to equipment control, modular automation design, and manufacturing system integration. Strong understanding of cGMP manufacturing operations, automation system lifecycle principles, change control, data integrity, and computerized system validation requirements. Experience supporting the design, startup, commissioning, qualification, troubleshooting, and lifecycle management of GxP automation systems. Skilled in reading and interpreting engineering documentation such as Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), control narratives, functional specifications, electrical drawings, network diagrams, and automation architecture drawings. Strong knowledge of engineering design and safety review processes such as HAZOP, design reviews, and model reviews. Strong analytical, technical problem-solving, and root cause analysis skills with a focus on system reliability and continuous improvement. Excellent communication and cross-functional leadership skills with demonstrated ability to influence technical decisions across engineering, manufacturing, quality, digital, IT, and external vendor organizations. Demonstrated ability to mentor engineers and provide technical leadership without requiring direct reporting relationships. Here’s What You’ll Bring to the Table (Preferred Qualifications) Experience with PackML and OEM implementations of PackML, ISA-88, and ISA-95 models. Experience developing reusable equipment modules, parameter frameworks, procedural models, and standardized automation libraries. Experience with serialization systems, machine vision, robotics, visual inspection systems, and/or high-speed packaging equipment. Experience integrating automation systems with historians, MES