Job Description
Support the design, logistics, integration, and operation of automated packaging lines interfacing with the Automated Warehouse, including Automated Storage and Retrieval Systems (ASRS) and Automated Guided Vehicles (AGVs). Support the creation of equipment and systems specifications based on material, compliance and system operator requirements. Ensure all automation systems meet CGMP, 21 CFR Part 11 and FDA requirements. Lead ASRS, AGVs and Automated Warehouse Compliance documentation. Ensure ASRS/AGV design and operation meet all safety, quality, and regulatory compliance requirements. Support commissioning, qualification, validation, and operation of new AOH automated packaging lines. Lead and support the development, testing, implementation, validation, and operation of critical automation and software systems. Support Commissioning, Qualification, and Validation (CQV) activities for packaging, ASRS, and AGV systems. Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. Ensure commissioning and qualification activities align with project requirements, milestones, and schedule commitments. Apply engineering principles and practices across automation, controls, robotics, and integrated systems. Demonstrate a strong understanding of OT/IT convergence, industrial networks, and system integration. Support and review machine controls design, including PLCs and HMI/SCADA platforms such as Allen-Bradley, Siemens, RSView, PanelView, and equivalent systems. Support site computer systems validation (CSV) activities and data integrity requirements. Work closely with ASRS and AGV vendors/consultants, ensuring contracts, technical specifications, and deliverables meet the customer’s requirements. Collaborate with users, peers, and management to ensure appropriate standardization and alignment. Demonstrate the ability to lead cross-functional initiatives and encourage critical, creative problem solving. Effectively lead and influence teams, achieving both technical outcomes and strong collaboration.
