Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Position Summary : The Vision Engineer is responsible for the technical leadership, lifecycle management, and continuous improvement of automated and manual visual inspection (AVI/MVI) capabilities and associated systems, including serialization / track & trace, variable code printing, and data matrix coding. The role provides subject matter expertise to Operations, Quality, Engineering, MSAT, and central functions to ensure compliant, robust, and best-in-class inspection and serialization solutions for sterile and parenteral products. Responsibilities Technical Leadership & Expertise Act as the SME for Automated and Manual Visual Inspection (AVI/MVI), providing expert support across Operations, Quality, Engineering, MSAT, and central teams. Lead the design, development, and implementation of inspection standards for sterile and parenteral products. Maintain awareness of new and emerging technologies, including AI-enabled inspection tools, ensuring the site continues to apply best-in-class solutions. Provide technical governance for inspection and vision system changes, ensuring appropriate risk assessment, validation impact assessment, and compliant change control. Own/lead technical troubleshooting of inspection performance issues (false rejects, missed defects, performance drift), including root cause analysis and corrective actions. Act as the site SME for serialization and track & trace systems, ensuring compliant operation and data integrity across packaging operations. Lead integration and support of SAP interfaces related to serialization/packaging execution and master data flows (as applicable). Support implementation, operation, and issue resolution for TraceLink and/or equivalent regulatory compliance solutions (commissioning, aggregation, EPCIS/data exchange, exception handling). Lead/coordinate requirements for variable data printing (label/carton/bottle), including print/verify strategies and interoperability with packaging/line control systems. Ensure robust Data Matrix coding implementation and verification (ISO/GS1 expectations where applicable), including readability/grade performance, camera/lighting configuration, and reject logic. Drive governance for serial number management, rework/returns/recall support processes, and line exception workflows in collaboration with Quality and Packaging. Manage and deliver an investment and development project portfolio, ensuring timely, compliant, and value-adding outcomes. Coordinate cross-functional stakeholders and ensure alignment with site and network strategy. Partner with suppliers/OEMs and integrators to deliver inspection and serialization upgrades, including URS development, FAT/SAT execution, and handover to operations. Monitor process performance and use data to drive improvement in inspection capability and product lifecycle management. Apply structured problem-solving techniques (e.g., RCA, FMEA, DMAIC, 5 Why, Gemba) to identify root causes and implement sustainable solutions. Ensure validation/qualification and compliance activities are executed to GMP standards (e.g., CSV where applicable; IQ/OQ/PQ; periodic review; data integrity expectations). Support investigations/deviations related to inspection, leak detection, printing/verification, or serialisation, ensuring timely and effective closure with robust CAPAs. Develop and implement training programmes for quality inspectors, operators, and technical staff, including manual visual inspection qualification. Coach and mentor colleagues to build inspection and serialization competency within the site technical/MSAT team. Author and maintain relevant procedures, work instructions, and technical documentation (e.g., SOPs, protocols, reports) in line with site standards. Qualifications/Experience: Strong experience working in GMP regulated environments, ideally sterile, parenteral, or equivalent high-compliance operations. Demonstrated technical problem-solving capability and experience applying structured methodologies. Strong stakeholder management and communication skills across Operations, Engineering, Quality, and/or technical functions. Degree in Science/Engineering (or equivalent relevant industry experience). Proven capability in serialization / track & trace systems, including shopfloor/line integration and operational support. Experience with SAP integrations impacting packaging/serialisation processes and/or master data flows. Experience supporting Trace Link (or equivalent) including commissioning/aggregation and exception handling workflows. Experience with variable code printing and verification (print/inspect/reject), including Data Matrix coding implementation and performance monitoring. 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