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140 results for Computerised System Validation Engineer jobs in Sint Agatha Berchem within a 30 km radius
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Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems. * Certification in computer system validation or equivalent is a plus. * Experience in a computer systems validation role * Writing, reviewing and approving of validation plans and validation summary reports * Ensure QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerized systems. * CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …) * Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …) * University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems. * Certification in computer system validation or equivalent is a plus. * Experience in a computer systems validation role * Writing, reviewing and approving of validation plans and validation summary reports * Ensure QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerized systems. * CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …) * Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …) * University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
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As a Senior Test & Validation Engineer, you will play a key role in ensuring Xenics products meet the highest performance, reliability, and safety standards. You will be responsible for defining, executing, and improving test strategies for advanced imaging systems, while mentoring and supporting product development from prototype through industrialization. * Define validation and verification plans for new products and platforms. * Contribute to building scalable, robust validation processes to support high-volume industrialization. * Support customer-specific validation when required. * 5+ years of experience in test engineering, validation, or reliability engineering in a high-tech environment
As a Senior Test & Validation Engineer, you will play a key role in ensuring Xenics products meet the highest performance, reliability, and safety standards. You will be responsible for defining, executing, and improving test strategies for advanced imaging systems, while mentoring and supporting product development from prototype through industrialization. * Define validation and verification plans for new products and platforms. * Contribute to building scalable, robust validation processes to support high-volume industrialization. * Support customer-specific validation when required. * 5+ years of experience in test engineering, validation, or reliability engineering in a high-tech environment
Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections. * Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval. * Ensure adequate quality reviews (periodic system quality reviews, quarterly utilities monitoring reports) * Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures * Experience with Quality Management Systems and Auditing is an asset
Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections. * Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval. * Ensure adequate quality reviews (periodic system quality reviews, quarterly utilities monitoring reports) * Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures * Experience with Quality Management Systems and Auditing is an asset
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We are expanding and looking for a Engineering Project Manager (or similar profiles such as Project Engineer, Technical Project Lead, Railway Engineer, , System Engineer) who enjoys taking responsibility for technology, execution, client interaction, and project outcomes and will contribute to improving the railway systems and have a direct societal impact. Project Manager, Project Manager Engineer, Project Engineer, Technical Project Lead, System Engineer, Railway Engineer, Rolling Stock Engineer, Electromechanical Project Leader, Railway Project Leader, , , , , , Electromechanics, Industrial Engineer Electricity, Automation Engineer, Technical Project Leader, Railways, Rail Engineering, Rolling Stock, Tram and Metro, Train ...
We are expanding and looking for a Engineering Project Manager (or similar profiles such as Project Engineer, Technical Project Lead, Railway Engineer, , System Engineer) who enjoys taking responsibility for technology, execution, client interaction, and project outcomes and will contribute to improving the railway systems and have a direct societal impact. Project Manager, Project Manager Engineer, Project Engineer, Technical Project Lead, System Engineer, Railway Engineer, Rolling Stock Engineer, Electromechanical Project Leader, Railway Project Leader, , , , , , Electromechanics, Industrial Engineer Electricity, Automation Engineer, Technical Project Leader, Railways, Rail Engineering, Rolling Stock, Tram and Metro, Train ...
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The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site. * Validation Activities * Plan, execute, and document validation activities associated with new product introduction. * Ensure validation documentation complies with GMP and regulatory standards. * Conduct risk assessments for processes and systems. * Support process changes and system updates related to new product introduction. * Prepare technical and validation documentation. * Validation processes and documentation
The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site. * Validation Activities * Plan, execute, and document validation activities associated with new product introduction. * Ensure validation documentation complies with GMP and regulatory standards. * Conduct risk assessments for processes and systems. * Support process changes and system updates related to new product introduction. * Prepare technical and validation documentation. * Validation processes and documentation
Provide QA insight during system selection, onboarding, validation, and ongoing oversight. * Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers, ensuring they meet internal quality and regulatory expectations. * Collaborate with other and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data. * Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities. * Participate in vendor assessments with a focus on system integrity, validation, and compliance evidence. * Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities.
Provide QA insight during system selection, onboarding, validation, and ongoing oversight. * Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers, ensuring they meet internal quality and regulatory expectations. * Collaborate with other and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data. * Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities. * Participate in vendor assessments with a focus on system integrity, validation, and compliance evidence. * Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities.
The Documentation Management Expert (QMS Transformation) plays a key role in a cross‑functional program aimed at the end‑to‑end transformation of the Quality Management System (QMS). This position operates in a project context, focusing on definition, design, and standardization, and provides the foundation for future implementation within electronic document management systems (EDMS). * Collaborate with Quality Systems and IT to ensure metadata design is system-ready. System Readiness & Implementation Support * Support validation, user role definition, and data integrity considerations linked to the new documentation framework. * 3–7 years of experience in documentation management, quality systems, or related quality roles in the pharmaceutical industry.
The Documentation Management Expert (QMS Transformation) plays a key role in a cross‑functional program aimed at the end‑to‑end transformation of the Quality Management System (QMS). This position operates in a project context, focusing on definition, design, and standardization, and provides the foundation for future implementation within electronic document management systems (EDMS). * Collaborate with Quality Systems and IT to ensure metadata design is system-ready. System Readiness & Implementation Support * Support validation, user role definition, and data integrity considerations linked to the new documentation framework. * 3–7 years of experience in documentation management, quality systems, or related quality roles in the pharmaceutical industry.
Perform threat modeling for ML systems (poisoning, evasion, prompt injection). * 5 years or more experience with threat modeling methodologies adapted for ML systems.
Perform threat modeling for ML systems (poisoning, evasion, prompt injection). * 5 years or more experience with threat modeling methodologies adapted for ML systems.
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Assist with order processing and data accuracy in ERP/CRM systems. * Basic understanding of ERP/CRM systems is a plus.
Assist with order processing and data accuracy in ERP/CRM systems. * Basic understanding of ERP/CRM systems is a plus.
Support creation and validation of the future-state QA scheduling model, including prioritization rules, decision logic, roles, and supporting governance * Master's degree in sciences Pharmacist / master's in sciences / Bio Engineer pharmaceutical
Support creation and validation of the future-state QA scheduling model, including prioritization rules, decision logic, roles, and supporting governance * Master's degree in sciences Pharmacist / master's in sciences / Bio Engineer pharmaceutical
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The Service Description: Launch Excellence Project Engineering entails being responsible for managing validation aspects associated with the introduction of new products into the site. * Supporting and implementing process and system changes related to product introduction. * Experience in executing validation projects and proficiency in planning and project coordination are highly valued. * Experience in a Good Manufacturing Practices (GMP) environment and familiarity with risk assessment and validation processes are important.
The Service Description: Launch Excellence Project Engineering entails being responsible for managing validation aspects associated with the introduction of new products into the site. * Supporting and implementing process and system changes related to product introduction. * Experience in executing validation projects and proficiency in planning and project coordination are highly valued. * Experience in a Good Manufacturing Practices (GMP) environment and familiarity with risk assessment and validation processes are important.
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Your role will be critical in monitoring the systems and infrastructure at our customer site in Haren, working for a in the aviation sector. In this position, you will be the 1st line of support to monitor the behavior of critical-business systems and services, and responsible to take initial actions to diagnose, analyze, and restore systems/services. * Proactively monitor systems and infrastructure in scope (from network and infrastructure components, voice communication systems to mission critical systems); * Managing alerts raised by monitoring systems according to internal procedures; * Apply procedures to restore systems and services and take part in planned and unplanned interventions;
Your role will be critical in monitoring the systems and infrastructure at our customer site in Haren, working for a in the aviation sector. In this position, you will be the 1st line of support to monitor the behavior of critical-business systems and services, and responsible to take initial actions to diagnose, analyze, and restore systems/services. * Proactively monitor systems and infrastructure in scope (from network and infrastructure components, voice communication systems to mission critical systems); * Managing alerts raised by monitoring systems according to internal procedures; * Apply procedures to restore systems and services and take part in planned and unplanned interventions;
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Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations * Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects * Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements * Experience with Quality Management System
Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations * Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects * Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements * Experience with Quality Management System
Enter and Manage Deviations and CAPA as per Source Quality (Veeva System) Deviation management processes. Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions. * Experience with managing non-compliance issues in Quality Management system as per deviation management processes. Familiarity with Veeva QMS system is an asset.
Enter and Manage Deviations and CAPA as per Source Quality (Veeva System) Deviation management processes. Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions. * Experience with managing non-compliance issues in Quality Management system as per deviation management processes. Familiarity with Veeva QMS system is an asset.
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Maintain structured archiving and a clear digital filing system
Maintain structured archiving and a clear digital filing system
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You conduct studies on electrical installations (low voltage and medium voltage) and associated low-current systems (security systems, alarms, structured cabling…).
You conduct studies on electrical installations (low voltage and medium voltage) and associated low-current systems (security systems, alarms, structured cabling…).
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You maintain oversight of prices and contracts and accurately enter these in the system. * You process all administrative tasks accurately in the ERP system and provide backup support to colleagues. * You are highly analytical and experienced with ERP systems (SAP is a plus).
You maintain oversight of prices and contracts and accurately enter these in the system. * You process all administrative tasks accurately in the ERP system and provide backup support to colleagues. * You are highly analytical and experienced with ERP systems (SAP is a plus).
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You're responsible for providing practical solutions that the business can implement when experiencing challenges with systems. * Needs Analysis: collaborate with internal departments to identify business needs and user requirements related to our Aftersales & IT systems ; * Documentation : maintain business models, functional designs, and system documentation ;
You're responsible for providing practical solutions that the business can implement when experiencing challenges with systems. * Needs Analysis: collaborate with internal departments to identify business needs and user requirements related to our Aftersales & IT systems ; * Documentation : maintain business models, functional designs, and system documentation ;
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As the organisation continues to scale at national level, it is strengthening its internal structures, systems and governance to sustainably support its growing social impact. You contribute to the professionalisation of processes and tools, support strategic decision-making, and act as a bridge between vision, systems and day-to-day reality. Systems & data * Systems-oriented approach: simplification, standardisation and automation with a human focus * Comfortable with financial systems, CRM and productivity tools (or equivalent platforms)
As the organisation continues to scale at national level, it is strengthening its internal structures, systems and governance to sustainably support its growing social impact. You contribute to the professionalisation of processes and tools, support strategic decision-making, and act as a bridge between vision, systems and day-to-day reality. Systems & data * Systems-oriented approach: simplification, standardisation and automation with a human focus * Comfortable with financial systems, CRM and productivity tools (or equivalent platforms)
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Assist in the implementation, maintenance, and documentation of IT systems and infrastructure
Assist in the implementation, maintenance, and documentation of IT systems and infrastructure
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The role ensures validation and verification of the HACCP plan, drives corrective and preventive actions, manages customer complaints and supports continuous improvement of product quality. * Bachelor's degree or Industrial Engineering (Chemistry/Food Technology), Bio‑Engineer or Master in Life Sciences, Food Science or similar.
The role ensures validation and verification of the HACCP plan, drives corrective and preventive actions, manages customer complaints and supports continuous improvement of product quality. * Bachelor's degree or Industrial Engineering (Chemistry/Food Technology), Bio‑Engineer or Master in Life Sciences, Food Science or similar.
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Fringe benefits such as a company car and insurance package, bonus system are included.
Fringe benefits such as a company car and insurance package, bonus system are included.
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At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. You will play a key leadership role across multi-disciplinary teams, guiding them through complex consulting engagements and be responsible for creating and positioning strategic change agendas within Kyndryl's largest accounts across the C-suite, spanning the intersection between complex Business and IT customer solutions, transformations that impact across the entire customer Eco-system.
At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. You will play a key leadership role across multi-disciplinary teams, guiding them through complex consulting engagements and be responsible for creating and positioning strategic change agendas within Kyndryl's largest accounts across the C-suite, spanning the intersection between complex Business and IT customer solutions, transformations that impact across the entire customer Eco-system.
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Monitoring logs and data sources (newsletters, EWS systems, security feeds, etc.). o Implementing and monitoring backup and recovery systems. * Knowledge of Data Loss Prevention (DLP) and intrusion detection systems is a bonus.
Monitoring logs and data sources (newsletters, EWS systems, security feeds, etc.). o Implementing and monitoring backup and recovery systems. * Knowledge of Data Loss Prevention (DLP) and intrusion detection systems is a bonus.
To help build out, maintain, and troubleshoot our rapidly expanding infrastructure, we are looking for a System Engineer. * Minimum 5 years of experience as System Engineer * Manage and monitor all installed systems and infrastructure * Install, configure, test and maintain operating systems, application software and system management tools * Proactively ensure the highest levels of systems and infrastructure availability * Experience with Linux based environments & System Admin * First experience with monitoring systems, i.e. Nagios, Check MK
To help build out, maintain, and troubleshoot our rapidly expanding infrastructure, we are looking for a System Engineer. * Minimum 5 years of experience as System Engineer * Manage and monitor all installed systems and infrastructure * Install, configure, test and maintain operating systems, application software and system management tools * Proactively ensure the highest levels of systems and infrastructure availability * Experience with Linux based environments & System Admin * First experience with monitoring systems, i.e. Nagios, Check MK