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:
This role requires a highly visual and highly technical individual with a strong interest in computer-based software optimisation for Automatic Visual Inspection in the pharmaceutical industry.
Previous experience in Automatic Visual Inspection is not essential. More important is the desire to work with this type of specialist equipment, develop deep technical expertise, and make a significant impact on the amount of high-quality product reaching the client and, ultimately, the patient.
The role is best suited to someone seeking to become a subject matter expert rather than pursuing a traditional managerial career path. The candidate should be motivated by hands-on technical problem solving, software and recipe optimisation, inspection performance improvement, and the development of robust visual inspection strategies.
They should be capable of supporting complex investigations, technology transfers, validation activities, and continuous improvement initiatives, while also helping to coach and develop future experts in Automatic Visual Inspection.
Responsibilities
Technical Leadership & Expertise
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Act as the SME for Automated and Manual Visual Inspection (AVI/MVI), providing expert support across Operations, Quality, Engineering, MSAT, and central teams.
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Lead the design, development, and implementation of inspection standards for sterile and parenteral products.
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Maintain awareness of new and emerging technologies, including AI-enabled inspection tools, ensuring the site continues to apply best-in-class solutions.
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Provide technical governance for inspection and vision system changes, ensuring appropriate risk assessment, validation impact assessment, and compliant change control.
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Own/lead technical troubleshooting of inspection performance issues (false rejects, missed defects, performance drift), including root cause analysis and corrective actions.
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Act as the site SME for serialization and track & trace systems, ensuring compliant operation and data integrity across packaging operations.
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Lead integration and support of SAP interfaces related to serialization/packaging execution and master data flows (as applicable).
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Support implementation, operation, and issue resolution for TraceLink and/or equivalent regulatory compliance solutions (commissioning, aggregation, EPCIS/data exchange, exception handling).
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Lead/coordinate requirements for variable data printing (label/carton/bottle), including print/verify strategies and interoperability with packaging/line control systems.
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Ensure robust Data Matrix coding implementation and verification (ISO/GS1 expectations where applicable), including readability/grade performance, camera/lighting configuration, and reject logic.
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Drive governance for serial number management, rework/returns/recall support processes, and line exception workflows in collaboration with Quality and Packaging.
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Manage and deliver an investment and development project portfolio, ensuring timely, compliant, and value-adding outcomes.
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Coordinate cross-functional stakeholders and ensure alignment with site and network strategy.
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Partner with suppliers/OEMs and integrators to deliver inspection and serialization upgrades, including URS development, FAT/SAT execution, and handover to operations.
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Monitor process performance and use data to drive improvement in inspection capability and product lifecycle management.
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Apply structured problem-solving techniques (e.g., RCA, FMEA, DMAIC, 5 Why, Gemba) to identify root causes and implement sustainable solutions.
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Ensure validation/qualification and compliance activities are executed to GMP standards (e.g., CSV where applicable; IQ/OQ/PQ; periodic review; data integrity expectations).
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Support investigations/deviations related to inspection, leak detection, printing/verification, or serialisation, ensuring timely and effective closure with robust CAPAs.
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Develop and implement training programmes for quality inspectors, operators, and technical staff, including manual visual inspection qualification.
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Coach and mentor colleagues to build inspection and serialization competency within the site technical/MSAT team.
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Author and maintain relevant procedures, work instructions, and technical documentation (e.g., SOPs, protocols, reports) in line with site standards.
Qualifications/Experience:
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Strong experience working in GMP regulated environments, ideally sterile, parenteral, or equivalent high-compliance operations.
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Demonstrated technical problem-solving capability and experience applying structured methodologies.
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Strong stakeholder management and communication skills across Operations, Engineering, Quality, and/or technical functions.
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Degree in Science/Engineering (or equivalent relevant industry experience).
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Proven capability in serialization / track & trace systems, including shopfloor/line integration and operational support.
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Experience with SAP integrations impacting packaging/serialisation processes and/or master data flows.
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Experience supporting Trace Link (or equivalent) including commissioning/aggregation and exception handling workflows.
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Experience with variable code printing and verification (print/inspect/reject), including Data Matrix coding implementation and performance monitoring.
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