Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When youre part of Thermo Fisher Scientific youll 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.
At Thermo Fisher Scientific each one of our 70000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
Required Experience:
IC
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen youre part of Thermo Fisher Scientific youll 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 perfor...
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When youre part of Thermo Fisher Scientific youll 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.
At Thermo Fisher Scientific each one of our 70000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
Required Experience:
IC
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