Employment Type : Full-Time
We are seeking a mid-level Automation Engineer to play a pivotal role in the design, integration, commissioning, qualification, validation, and operation of automated warehouse and packaging systems within a GMP-regulated environment. This role will support critical automation technologies including Automated Storage and Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs), and interfacing packaging line systems, ensuring they are designed, implemented, and operated in compliance with GxP, safety, quality, and regulatory requirements. This individual will serve as a technical subject matter expert and work closely with Packaging Operations, Warehouse, Quality, Manufacturing, Computer System Validation (CSV), IT/OT, and external automation vendors to deliver reliable, scalable, and compliant automation solutions. KEY RESPONSIBILITIES • Collaborate in the design, logistics, integration, and operational readiness of automated packaging lines interfacing with the automated warehouse, including ASRS and AGV systems. • Support the development of equipment and system specifications based on material flow, compliance requirements, and operator needs, ensuring systems meet cGMP, 21 CFR Part 11, and FDA requirements. • Lead and support compliance documentation for ASRS, AGVs, and automated warehouse systems. • Ensure ASRS, AGV, and related automation system design and operation meet all safety, quality, and regulatory compliance requirements. • Lead commissioning, qualification, validation, and startup support activities for new automated packaging and warehouse systems, ensuring technologies and processes perform as intended. • Lead and support the development, testing, implementation, validation, and ongoing operation of critical automation and software systems. • Partner closely with Quality Assurance, CSV, Packaging, Manufacturing, Warehouse, and IT/OT teams to maintain GxP compliance and support seamless system integration. • Apply sound engineering principles across automation, controls, robotics, and integrated manufacturing systems to drive reliable system performance. • Demonstrate strong knowledge of OT/IT convergence, industrial networking, and system integration in support of automated operations. • Support and review machine controls design, including PLC and HMI/SCADA platforms such as Allen-Bradley, Siemens, RSView, PanelView, and equivalent systems. • Support site computer system validation activities and ensure adherence to data integrity requirements for automation-related systems. • Coordinate with third-party vendors, consultants, and system integrators to manage schedules, technical deliverables, contracts, and project execution in alignment with project goals and timelines. • Collaborate with end users, peers, and management to drive standardization, alignment, and continuous improvement across automation systems and processes. • Lead cross-functional initiatives, influence project teams, and promote critical thinking and creative problem solving to achieve technical and operational outcomes.