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Ingenieur

8 resultaten

Business developer – Smart-cities - Green Technologies - Germany

SmartNodes ist ein innovatives belgisches Green-Tech Startup, das in der nachhaltigen Entwicklung der Smart Cities aktiv ist.

Mit Sitz in Lüttich entwickelt SmartNodes intelligente Straßenbeleuchtungslösungen, die auf High-Tech-Controllern basieren, um Straßenbeleuchtung nur in Anwesenheit von Verkehrsteilnehmern zu be-treiben. Durch die Integration von Umweltsensoren, Parksensoren usw. wird das öffentliche Lichtnetz von SmartNodes zur treibenden Kraft hinter Smart City-Netzwerken. Bitte besuchen Sie unsere Homep-age unter www.smartnodes.be.

Kunden von SmartNodes sind Städte, Regionen und Vertriebsnetzwerke weltweit. Um unsere geschäft-lichen Aktivitäten weiterzuentwickeln, suchen wir aktiv nach einem (m / w):

Business developer – Smart-cities

Verantwortlichkeiten:

Sie leisten dem Business Development Manager Berichterstattung und erweitern somit mit dessen Unterstützung das Geschäft von SmartNodes auf internationaler Ebene, hauptsächlich in Deutschland und der DACH-Region. In Ihrer Region entwickeln Sie die Attraktivität der Marke auf dem Markt und erreichen die Verkaufsziele des Unternehmens.

Ihre Hauptaufgaben sind:

  • Sie analysieren die Marktentwicklung und identifizieren Geschäftswachstumschancen und -risiken.
  • Sie schlagen relevante Verkaufsaktionspläne vor, um die Verkaufsziele zu erreichen.
  • Sie initiieren positive Beziehungen zu Interessenten, Kunden und Vertriebskanälen.
  • Sie führen den gesamten Verkaufsprozess, einschließlich der Antwort auf Ausschreibungen und Geschäftsabschluss.
  • Sie konstruieren, unterstützen und motivieren ein effizientes Vertriebsnetz lokaler Partner.
  • Sie entwickeln angepasste lokale Marketing-Tools und Aktionen.
  • Sie berichten regelmäßig über die Entwicklung der Arbeit.
Profil:
  • Master-Abschluss in Business, Engineering oder gleichwertig durch Erfahrung.
  • Idealerweise eine erste Erfahrung in einer kaufmännischen Position mit technischen Produkten. Juniorprofile sind ebenfalls willkommen.
  • Ergebnis- und kundenorientiert, streng, autonom und flexibel.
  • Bereit, sich mit den Aktivitäten des öffentlichen Sektors zu befassen.
  • Sie sind bereit, ungefähr 50% Ihrer Arbeitszeit zu
  • Sie sprechen fließend Englisch und Deutsch. Weitere Sprachkenntnisse, insbesondere der französischen Sprache, sind von Vorteil.
Angebot:
  • Eine herausfordernde Geschäftsentwicklungsposition in einem schnell wachsenden Start-up- Unternehmen.
  • Die Möglichkeit, in ein Unternehmen für nachhaltige Entwicklung und grüne Technologien einzu
  • Vielfältige Kontakte zu Fachleuten auf internationaler Ebene.
  • Bedeutende Lern- und Entwicklungsmöglichkeiten.
  • Ein attraktives Gehaltspaket inklusive eines Aktienoptionsplans.

Senior Process Optimization Engineer - Biotech - Mont-Saint-Guibert

NOVADIP-BIOSCIENCES is an innovative biotech company, based in the Walloon Region (Mont-Saint-Guibert), with a strong expertise in the development of novel regenerative medicines. This human-sized structure is a leader in first-in-class treatments for hard and soft tissues.

If you are sharing their vision of developing life-improving and life-saving products and if you are looking for new challenges amongst a dynamic and innovative team, consider collaboration with their fast growing company.

In order to support its exciting development, we are looking for a (m/f):

Senior Process Optimization Engineer

Responsibilities :

As a Senior Process Optimization Engineer, you will be involved from design to validation, in the development of new manufacturing processes adapted to innovative cell therapy products.

Your main responsibilities are:

  • Provide leadership to work on development and continuous improvement of the manufacturing process.
  • Define industrial requirement for process automation in cGMP environment (technical and functional specifications).
  • Consulting engineering and/or equipment suppliers for development of automated close systems in production and quality control of cell-based therapies.
  • Set-up of development projects, coordination of external and internal dedicated team (ensure that industrial requirements and biological constraints are well understood), follow-up of projects execution, budget and reporting.
  • Contribute in implementation of new technologies and establish process validation plan in accordance with quality requirements and guidelines.
  • Set-up comparability studies to increase the operational scale of autologous manufacturing process (scale-out).
  • Ensure technology watch of the state-of-the-art technologies in process industrialization and automation of Advanced Cell Therapy Medicinal Products.
  • Manage selection of technologies and act as a scientific expert to ensure good decision making within the department.

Profile :

  • Engineer, Master or PhD with 5 years in process optimization/automation within the GMP biotech/pharma industry.
  • Strong knowledge of industrialization strategies and automation solution for biotech/pharma production.
  • Strong knowledge of quality requirements (GMP, clinical trials, comparability studies, process validation, aseptic practices) and working knowledge of requirements for aseptic manufacturing.
  • Ability to provide leadership and to manage priorities, follow assignments through to completion and meet deadlines.
  • Ability to work in a team and collaboratively in a matrix organization (R&D, QC, QA, RA).
  • Flexible for travelling, organized and pro-active.
  • Excellent oral and written communication skills in English, and ideally also in French.
Offer:
  • A diversified full-time permanent position within a high-potential innovative biotech company.
  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.

Product Specialist - Medical Device - Liège

Headquartered in Liège, Dim3 develops and markets innovative eHealth software and devices in the area of Clinical nutrition to facilitate medical decisions and enhance the life of patients.

Dim3’s technologies bring a great knowledge of healthcare and clinical biometry together with disruptive 3D scanning and software engineering experience. Dim3’s clinical nutrition management tools and connected products integrate automatic medical data collection, interpretation and visualization to give healthcare professionals clear and objective information in real-time.

For more information, please visit: www.dim3.com

In order to support Dim3’s development, we are actively looking for a (m/f):

Product Specialist

Responsibilities:

As a Product Specialist, you guide Dim3’s products to even higher levels. You have a key role in the team. You deal with medical practitioners, customers and partners in order to determine the future direction of Dim3’s applications including specific features, functionality and business models. You deeply understand the pains patients feel and invent ways to translate their needs into smart software.

Reporting to the CTO, you work in close cooperation with customers, the Management Team, Product Development, Clinical Affairs and Sales. Your main responsibilities are:

  • You initiate the product roadmap and strategy in line with market needs and business priorities.
  • You define the pricing strategy and constantly analyze market trends and competitors’ evolution.
  • You support the Sales team in analyzing customers project requirements, in defining adapted technical solutions, and in developing written and oral commercial proposals.
  • You define new products specifications or improvements in an efficient way.
  • You manage the release process in collaboration with the other departments.
  • You develop adapted local marketing tools and actions.
  • You report work evolution on a regular basis.
Profile:
  • Master’s degree in Business, Engineering or equivalent through experience.
  • 5 years of experience in a Product Management position with technical products. Experience in medical software and/or devices is a plus. Experience in nutrition is also an asset.
  • Results and customer oriented, rigorous, autonomous and flexible.
  • Analytical, organized, team player, open-minded with a start-up mind-set.
  • Fluent in French and in English. The command of any other language is an asset.
  • Strong oral and written communication.
  • Willing to travel for short periods (20% of your time) on a regular basis.
Offer:
  • A challenging position with direct impact on patients’ health and quality of life.
  • The opportunity to jump into an innovative medical software engineering company, a fast-growing start-up environment where teamwork, results and patient care are very important.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package.

Manager de Fabrication et Industrialisation - Chemicals - Belgique

Reconnu comme l’une des 5 « supermajors », notre client est un acteur indiscutable de l’industrie pétrolière et gazière mondiale ainsi qu’un leader en chimie industrielle.

Dans un environnement de plus en plus compétitif du fait des importations de produits de commodités et en raison de la protection de sa propriété intellectuelle et de la réussite de ses développements catalytiques, notre client a décidé de développer, produire et vendre des catalyseurs métallocènes.

Pour assurer le développement de l’usine de polymères de notre client au sud de Bruxelles, nous sommes activement à la recherche d’un (m/f) :

Manager Production et Industrialisation

Catalyseurs Nouvelles Générations
Responsabilités :

En tant que Manager de Fabrication et Industrialisation de Catalyseurs Nouvelles Générations, vous coordonnez le démarrage de l’unité de production de ces catalyseurs. Rapportant au Comité de Direction, vous supervisez l’équipe de production et êtes le référent technique.

Les responsabilités suivantes vous sont confiées :

  • Coordonner et optimiser la production des catalyseurs en termes de ressources, process et de résultats selon les spécifications requises.
  • Optimiser l’application de nouvelles recettes et versions catalytiques, en liens étroits avec la recherche et le service procédés.
  • Assurer la rentabilité financière de l’unité de production en veillant à la réduction des coûts (dégoulottage, récupération de solvants, etc.).
  • Implémenter et veiller au respect des normes de qualité (QC/QA) et de sécurité.
  • Implémenter un mode opératoire et assurer le suivi de performance.
  • Collaborer étroitement avec la supply chain.
  • Être le garant technique des catalyseurs achetés à des tollers tiers.
  • Veiller au suivi clientèle au niveau mondial en termes de performance.
  • Superviser, motiver et développer les collaborateurs de l’équipe de production.
Profil :
  • Vous êtes titulaire d’un Master/PhD en chimie.
  • Vous disposez de minimum 10 années d’expérience dans le scale-up et la fabrication industrielle de catalyseurs polyoléfines. A ce titre, vous avez acquis de solides connaissances en polymérisation et idéalement dans les applications avales.
  • Vous possédez une expérience en tant que manager d’une équipe d’exploitation de catalyseurs (pilote/unité industrielle).
  • Vous démontrez de l’aisance dans la gestion de projets et apprécier le travail en équipe.
  • Vous êtes autonome, rigoureux(se), doté(e) d’une forte capacité décisionnelle et de leadership.
  • Vous possédez une très bonne connaissance de l’anglais.
  • Vous êtes disposé(e) à vous déplacer occasionnellement sur tous les continents.
  • Vous êtes prêt(e) à vous relocaliser à l’international.
Offre :
  • Une fonction stratégique et diversifiée liée à des projets innovants.
  • Des opportunités de développement et un plan d’évolution structuré.
  • Intégrer une entreprise industrielle innovante et renommée au niveau mondial.
  • Des défis professionnels et stimulants et des contacts humains enrichissants.
  • Une offre salariale compétitive, en ligne avec votre expérience.

Ingénieur Commercial Grands Comptes - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz du groupe EDF en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe commerciale de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Ingénieur Commercial Grands Comptes

Responsabilités :

En tant qu’Ingénieur Commercial Grands Comptes, vous participez activement au développement du terminal tant d’un point de vue commercial qu’opérationnel. Rapportant au Directeur Commercial, vous êtes responsable de la relation commerciale avec les clients et les différents partenaires de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Entretenir et développer la relation commerciale avec les clients de Dunkerque LNG, EDF et Total.
  • Veiller au respect des contrats de réservation de capacité et de leur mise en œuvre opérationnelle.
  • Supporter la Direction Commerciale dans le pilotage de la relation contractuelle et/ou opérationnelle des prestataires : suivi du contrat de service, lancement et réception de nouveaux développements, etc.
  • Prospecter de nouveaux clients, notamment en participant à différents forums et salons industriels.
  • Planifier et gérer l’activité du terminal : bateaux, émission, stock, etc.
  • Rapporter de manière régulière la performance commerciale et opérationnelle du terminal.
  • Participer aux astreintes de soutien à raison d’une semaine sur quatre.
Profil :
  • Vous êtes titulaire d’un Bac+5 de type école de commerce, d’ingénieur ou universitaire.
  • Vous disposez de 10 ans d’expérience dans une fonction commerciale dans le secteur gazier.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un très bon relationnel.
  • Vous êtes flexible, autonome, organisé(e), analytique et rigoureux(se).
  • Vous communiquez aisément en Français et en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière régulière à Dunkerque et ponctuellement à travers le monde.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

International Technical Project Manager - Industry - Genk

Created in 2011, Aperam is a leading global stainless steel and specialty steel producer with key industrial facilities located in France, Belgium, Germany and Brazil. Aperam is successfully implementing a strategy based on operational efficiency and innovation in their products and services.

Aperam products are sold in over 40 countries to customers in the aerospace, automotive, medical, construction, household appliances, catering and industrial processes industries. In 2017, Aperam employed about 9,600 people with a turnover of $5.051 million.

In order to join its center of industrial excellence in Genk, we are looking for an (m/f):

International Technical Project Manager

As an International Technical Project Manager, you implement and follow up global projects in the different plants (mainly in Europe) in the field of robotization, automation, digitalization/connectivity, production IT (MES, WMS, ERP Interfaces), energy saving, process innovation and shop floor layout.

Responsibilities:
  • Manage end-to-end projects: initiation, planning, implementation, monitoring, close-out, etc.
  • Participate in the company’s digital transformation (Industry 4.0).
  • Accelerate the achievement of business objectives and set up new innovative projects.
  • Be responsible for the conception, calculation and quoting of automation solutions for the Aperam production network.
  • Define and develop Aperam automation standards.
  • Set up and report the project KPIs on quality control, timing, budget and stakeholder satisfaction.
  • Collaborate in the project team as a competent partner for automation.
  • Communicate with different internal and external stakeholders : suppliers, institutes, experts, etc.
  • Report work evolution on a regular basis.
Profile:
  • Master degree in engineering with a specialization in mechatronics, electricity, electromechanics or energy management.
  • Minimum 5 years of experience as a Technical Expert in an industrial environment with a few years’ experience in continuous improvement project management.
  • A certification in project management (preferably Prince 2).
  • Strong leadership and communication skills with hands-on and pragmatic mindset.
  • Autonomy, proactivity, analytical and problem solving skills.
  • Ability to work within a multicultural environment.
  • Willingness to travel around 60% of your work time.
  • Fluency in English. Knowledge of other European languages is a plus.
Offer:
  • A unique career opportunity to participate in internal and external training courses, following a guided learning path on both technologies and processes.
  • A real career booster and transition to higher and transverse positions within the group.
  • An international exposure, with learning and development opportunities.
  • The opportunity to travel to the different company sites in Europe and Brazil.
  • An attractive compensation package in line with the position responsibilities and your experience.

Senior R&D Manager - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com. 

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Senior R&D Manager

Responsibilities:
  • You initiate and manage related projects.
  • You guide/manage risk management activities.
  • You create/review technical documentation and processes (as part of DHF, DMR, QMS).
  • You create verification and validation plans and coordinate their execution; apply statistical techniques in order to define samples sizes.
  • You organize and execute subjective evaluations (product reviews) to ensure all (product) requirements are met.
  • You review manufacturing documentation such as procedures/processes, BOMS and drawings.
  • You transfer and oversight of parts of manufacturing processes.
Profile:
  • Master’s degree in Engineering, Informational Systems or Computer Science.
  • 10+ years’ experience working in development of Class III (minimum IIb) medical devices (or other relevant regulated industry).
  • Ideally experience with hardware/software and catheters.
  • Experience in creating Risk Management plan, (Software) Hazard Analysis, DFMEA, PFMEA, Risk Management reporting.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Senior Design Assurance Manager - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com.

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Senior Design Assurance Manager

Responsibilities:
  • You provide design assurance support and oversight for product development activities throughout product lifecycle.
  • You create, review and/or execute IQ, OQ, PQ and test method development.
  • You ensure product development follows company procedures and design control requirements.
  • You review and approve design verification and design validation test protocols and reports.
  • You support protocol sample size calculations and data analysis with use of acceptable use of statistical methods/techniques.
  • You drive robust design reviews within R&D teams.
  • You ensure compilation and maintenance of product Design History Files.
  • You document traceability of requirements through design output and to design verification and/or design validation.
  • You lead the risk management process for pre-market and post-market assessments of assigned products.
Profile:
  • Bachelor or Master’s degree in Engineering, Life Sciences or another related field.
  • 10+ years’ experience working in a Quality or Engineering capacity with Class III medical devices. Experience with catheters and active devices preferable.
  • Experience with all phases of the product development process including clinical investigation.
  • Experience in creating and maintaining Risk Management Files.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards.
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Andere loopbaanmogelijkheden

31 resultaten

Research Assistant – Flow Cytometry and Serology - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences is a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium). Caprion Biosciences offers analytical services to biopharmaceutical companies ranging from mass spectrometry-based analytical services to the characterization of the human immune response in clinical samples.

Caprion Biosciences operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotech companies.

In the context of its growing immune monitoring service offering in Gosselies (Belgium), we are looking for a (m/f):

Research Assistant – Flow Cytometry and Serology

Responsibilities :

Reporting to the Laboratory Manager and working closely with Principal Scientists, the Research Assistant will work within a team focusing on the characterization of the cellular (ELISPOT and various flow cytometry assays such as phenotyping of PBMC, detection of intra-cellular cytokines, etc) and of the humoral (ELISA, Luminex, viral neutralization tests, etc) immune response.

Tasks include :

  • Perform immunoassays according to current standard operating procedures;
  • Participate to the writing and/or to the review of method SOP and worksheets;
  • Manage reagents inventories and orders;
  • Participate to the technical management of the laboratory;
  • Perform work according to internal quality standards, apply relevant Quality System procedures and participate to the continuous improvement of Quality documents;
  • Attend relevant internal training activities;
  • Depending on the experience level of the candidate, additional tasks may include:
    • Act as a leader in the laboratory for specific studies;
    • Work with the Principal Scientist to prepare experimental plans needed for the conduct of immune monitoring assays;
    • Participate in the development and qualification/validation of complex methods;
    • Participate in experiment planning and problem solving.
Profile :

The applicant must hold a bachelor degree or a master’s degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology and demonstrate a relevant laboratory experience. Theoretical and practical knowledge of techniques related to cellular and humoral immunology is required. Experience in cell culture and handling infectious materials in BL2+ environment is an asset.

The applicant must :

  • Demonstrate excellent organisational skills.
  • Demonstrate schedule adaptability and flexibility.
  • Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes.
  • Be willing to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP).
  • Be functional in French (spoken and written) and have a functional knowledge of written English. Knowledge spoken English is an asset.
Offer :
  • Full time permanent contract, with possibility of rapid start.
  • Diversified tasks and responsibilities and interesting projects.
  • A professional, dynamic and stimulating work environment.
  • Training and development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.

Regulatory Manager - Medical Device - Liège

Founded in 2016, Oncoradiomics is an innovative and ambitious start-up established in Liège. Oncoradiomics’s strategic goal is to “revolutionize precision medicine”, by applying advanced artificial intelligence to clinical imaging.

Oncoradiomics focuses on tailoring cancer care to the clinical, imaging, biological and genetic characteristics of an individual patient so that the best outcome can be achieved.

Oncoradiomics holds several international grants and patents and is continuously developing and connecting with leading industrial and academic players to advance healthcare and the life sciences.

Regulatory Manager

Responsibilities:

As a Regulatory Manager, you lead and drive the execution of Oncoradiomics global regulatory strategy. Reporting to the CEO, you define and implement the regulatory policy in line with applicable directives, guidelines and legal requirements. Your main responsibilities are:

  • You drive regulatory strategy for EU/US markets: develop global regulatory strategies and drive the international product registration activities (with focus on EU, US, Canada, Australia, Japan, China and South Korea).
  • You prepare, organize, and submit global regulatory submissions/approvals.
  • You prepare and submit regulatory filings including, CE marking, traditional and special 510(k) applications, letters to file, technical files, etc.
  • You ensure regulatory requirements for establishment registrations, device listings, and registration licensing is maintained.
  • You perform MDR and MDV complaint reporting assessments.
  • You support the product development team in the implementation of regulatory requirements, including review of design input, risk management, and test documentation.
  • You perform regulatory assessment of product changes.
  • You proactively interpret regulatory guidelines and regulations, anticipate concerns, educate, and integrate requirements into product development programs.
  • You review and approve marketing materials to ensure compliance with advertising and promotional regulations.
  • You support internal and external audits.
Profile:
  • Master or PhD in life sciences or equivalent through experience.
  • 10 years experience in a RA position in the (software solutions) MedTech sector.
  • Proven track record of building strong relationships with internal and external stakeholders.
  • Ability to maintain multiple projects and meet timelines, including change management skills.
  • Client-centered and solution-oriented, with hands-on and pragmatic mindset.
  • Excellent leadership, communication and interpersonal skills.
  • Fluency in English.
Offer:
  • A challenging and diversified position within a high-potential innovative start-up company.
  • To work in a dynamic, respectful and professional
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Lead Scientist - Bio-Pharma/Biotech - Gosselies

ImmunXperts is a high-potential start-up based in Gosselies, Belgium. This fast-growing company offers a wide range of Immunology services with a constant will to develop customized solutions for its clients.

The offerings include in vitro assays to assess the immunogenic potential of test molecules using T cell activation and proliferation assays as a surrogate marker for the induction of Anti-Drug-Antibodies. On the immuno-oncology side, ImmunXperts develops in vitro assays to assess the functionality of candidates. ImmunXperts continuously develops new cellular immune-assays to assist biotech and pharma companies directly in their product development. Other such collaborative services include protocol optimization and in-house training. More info can be found on www.immunxperts.com.

ImmunXperts’ team works in an open-minded, science-driven and fast-paced environment. In order to support their growth, ImmunXperts is actively looking for a (m/f) :

Lead Scientist

Mission:

We are looking for a Lead Scientist to plan, direct and coordinate ImmunXperts’ R&D lab operations.

You are responsible for improving overall performance, productivity and efficiency through the implementation of effective methods and strategies. You show thorough scientific background combined with excellent organizational and interpersonal skills. You coordinate a team of high-level scientists who lead between 50 and 100 different projects per year.

Main responsibilities:

On a daily basis, you understand and dive into ImmunXperts’ team activities in order to:

  • Coordinate cross-project activities together with project leaders:
    • Monitor project progress and take corrective actions if needed, ensuring that all projects are delivered on time and using foreseen resources.
    • Lead (Senior) Scientists, providing them with guidance where and when appropriate: cellular assays development and optimization, data analysis, client interaction, technical & scientific writing.
    • Organize and manage priorities in order to meet project and client deadlines.
    • Strong interest to participate in all lab activities when appropriate (challenging project, temporary high workload, transfer of knowledge,…).
  • Ensure overall lab quality through:
    • Use of standard methods and procedures by all, for all experiments.
    • Optimize resources flow and allocation inside the lab to maximize operational performance.
    • Coordinate continuous improvement initiatives to maintain an overall high level of quality (procedures, techniques, equipment, security…)
  • Daily manage lab technicians in the best interest of all projects and transversal activities, leading by example.
  • Possibility to attend international conferences and give technical and scientific presentations. Occasional travel to prospects and clients worldwide.
Profile requirements:
  • Master or Ph.D. in Immunology, Biology, Pharmaceutical Science, or equivalent by experience.
  • 5 to 10 years experience with cellular assays, in an industrial/biotech environment.
  • Strong experience in elisa and flow cytometry. Luminex and elispot expertise are a plus.
  • Ability to see the global picture with a rigorous mindset and attention for details.
  • Leadership and organizational skills. Clients, solutions and results oriented.
  • Outstanding communication and inter-personal skills.
  • Excellent knowledge of MS Office; working knowledge of program/project management software (Basecamp, MS Project etc.) is a strong advantage.
  • Excellent command of English (written and spoken). French and any other language is an asset.
  • Knowledge of project/program management techniques and methods is an advantage.

Responsable QHSE - Energie - Dunkerque

Dunkerque LNG (Dunkerque Liquefied Gaz Naturel) est une filiale à 65 % du groupe EDF SA, 25 % de l’opérateur belge Fluxys et 10 % de Total. L’exploitant du terminal méthanier de Dunkerque est Gaz-OPALE, filiale d’exploitation de Dunkerque LNG.

GAZ-OPALE est en charge de la conduite, de la maintenance et du respect des exigences HSE (Hygiène Sécurité et Environnement). Le terminal méthanier est un site ICPE (Installation Classée pour la Protection de l’Environnement) qui suit la directive SEVESO III seuil haut.

Responsable QHSE

Responsabilités :

En tant que Responsable QHSE, votre mission est de définir et coordonner la politique «qualité, hygiène, sécurité et environnement» de l’ensemble du terminal méthanier. Pour ce faire, vous pouvez compter sur une équipe de 2 personnes et sur un réseau de partenaires externes. Rapportant au Directeur d’Exploitation, vous faites partie du Comité de Direction de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Implémenter et coordonner le système de gestion de la sécurité : élaboration des plans d’urgence et mise en œuvre d’exercices.
  • Coordonner la sécurité du site, gérer et analyser les événements et incidents.
  • Évaluer et sensibiliser aux risques des postes de travail.
  • Participer au Comité d’Hygiène, de Sécurité et des Conditions de Travail (CHSCT).
  • Obtenir la triple certification Iso 9001, 14001, OHSAS 28001 par la mise en œuvre de documents contrôlés.
  • Garantir la mise en œuvre des évolutions réglementaires et assurer la gestion des déchets.
  • Veiller à la bonne application des règles d’accès au site.
  • Participer aux astreintes de la cellule de crise opérationnelle à raison d’une semaine sur cinq.
Profil :
  • Vous êtes titulaire d’un Bac+5 QHSE, scientifique, ou équivalent par expérience.
  • Vous possédez une expérience réussie de 5 à 10 ans en tant que Responsable QHSE d’un site industriel type SEVESO. Une première expérience en management est un plus.
  • Vous communiquez aisément en français et en anglais.
  • Vous êtes autonome, rigoureux(se) et faites preuve d’un esprit d’ouverture, d’écoute et de synthèse.
  • Vous appréciez le travail d’équipe et possédez une grande aisance relationnelle.
  • Vous êtes habitué(e) à travailler dans un environnement structuré et exigeant (ISO 9001-14001, OHSAS 28001).
  • Vous êtes basé(e) dans les environs de Dunkerque et êtes disposé(e) à vous déplacer ponctuellement en France et à l’étranger (Bruxelles, Zeebrugge, etc.)
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Head of CMC - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please visit www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of CMC

Responsibilities :

As Head of CMC, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies.

You report directly to the CEO and are part of the Executive management.

Your main responsibilities include:

  • Lead the overall management of product and process development.
  • Manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies.
  • Identify, select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP).
  • Manage the non-GMP productions and associated analytical development activities.
  • Deliver robust, scalable and cost-effective manufacturing routes.
  • Implement appropriate analytical methods and protocols in coordination with QA.
  • Ensure the compliance of all CMO with relevant regulatory standards.
  • Define and execute plans for API and DP validation and registration, in coordination with QA and RA.
Profile :
  • PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
  • Relevant expertise in lab techniques focused on protein expression, isolation and analysis.
  • Strong experience in managing CMOs for the manufacture of cGMP APIs and DP.
  • Experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings.
  • Thorough knowledge of relevant FDA and EMEA regulations.
  • Experience with implementing technical, strategic and operational plans.
  • Excellent communication and organizational skills.
  • Ability to identify and resolve critical issues.
  • Fluency in French and English.
Offer :
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.

Research Associate – Target expression - Biotechnology - Brussels

Confo Therapeutics, a spin-off of VIB and VUB, is a drug discovery company built around a disruptive technology which enables it to address ‘undruggable’ GPCRs. The company is building a portfolio of transformative medicines in various disease areas.

Confo Therapeutics is currently located on the Etterbeek campus of the Vrije Universiteit Brussel and on the Technology Park in Zwijnaarde/Ghent. More information about Confo’s technology and strategy can be found on www.confotherapeutics.com.

For the expansion of the target discovery team in Brussels, we are looking for a (m/f):

Research Associate – Target expression

Responsibilities:
  • You will help to implement a state of the art cell culture lab and build an efficient cell culturing engine for different eukaryotic hosts.
  • You will overexpress GPCRs in different eukaryotic expression hosts and assess recombinant receptor expression (transient and stable cell lines).
  • You support the Confobody discovery teams to assess conformation sensitivity of antibodies in cell based assays.
  • You manage Confo Therapeutics’ cell line culture capacity and inventory aligned with the Data Management System.
  • You communicate experimental progress to the project teams.
Profile:
  • Bachelor in life sciences with at least one year experience in eukaryotic cell culturing in an industrial setting.
  • Proficient in eukaryotic cell transfection techniques and methods to assess heterologous protein expression such as flow cytometry and radioligand assays.
  • Experienced operator of flow cytometer and capable to analyse flow cytometry data is an asset.
  • Scientific integrity, solid analytical and problem solving skills.
  • Working accurately and self-motivating.
  • Enthusiastic team player in a small company setting.
  • Excellent communication skills in English.
Offer:
  • A competitive compensation package with extensive benefits.
  • An entrepreneurial and stimulating working environment in a growing and ambitious biotech company.
  • Excellent career development opportunity, with exposure to all aspects of R&D in the company.

Head of Regulatory Affairs - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please vist www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of Regulatory Affairs

Responsibilities:

As a Head of RA, you lead and drive the execution of ASIT global regulatory and quality assurance strategy. Reporting to the CEO, you are responsible for regulatory affairs, quality assurance, and compliance activities across the company. You define and implement the quality and regulatory policies in line with applicable directives, guidelines and legal requirements.

Your main responsibilities are as follows:

  • Develop, propose and implement the company regulatory & quality strategy.
  • Manage regulatory documents submissions for clinical studies, and product approvals.
  • Implement an efficient quality system and a continuous improvement culture within the company.
  • Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and follow-up of
submissions.
  • Support and advise project teams on regulatory and quality issues.
  • Provide technical review of data and reports for regulatory submissions.
  • Draft product labelling, instruction leaflets and packaging.
  • Participate in internal/external audits, inspections and provide post-inspection
follow-up.
  • Write and update SOP, work instructions, and policies.
Profile:
  • Master or PhD in life sciences or equivalent through experience.
  • 10 years experience in a RA and/or a QA management position in the Biotech/Pharma sector.
  • Track record in developing quality systems from EU/US clinical developments to product approval.
  • Thorough knowledge of ICH guidelines, GxP and related regulatory guidances.
  • Proven track record of building strong relationships with internal and external stakeholders.
  • Ability to maintain multiple projects and meet timelines, including change management skills.
  • Client-centered and solution-oriented, with hands-on and pragmatic mindset.
  • Excellent leadership, communication and interpersonal skills.
  • Familiar with MS Office solutions.
  • Fluency in English.
Offer:
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.

Assistant Commercial - Belgian Brewery - Péruwelz

La Brasserie Caulier est une entreprise familiale de la région de Tournai, située à Péruwelz. La brasserie produit ses propres bières depuis près de 20 ans et jouit d’une excellente réputation dans le secteur.

L’équipe actuelle, composée de 16 passionnés, brasse des bières 100% naturelles, appliquant des méthodes de fabrication artisanales.

Afin de soutenir la croissance de la Brasserie Caulier, nous sommes à la recherche d’un (h/f) :

Assistant Commercial – Customer Satisfaction Manager

Responsabilités :

En étroite collaboration avec le département logistique, comptable et l’équipe commerciale, votre mission principale est de garantir la satisfaction des clients. En ce sens, vous assurez le suivi des ventes et êtes le premier contact du client avec la Brasserie Caulier.

Vos responsabilités seront les suivantes :

  • Assurer l’accueil téléphonique des clients, l’accueil de la brasserie et d’éventuelles visites de brasserie.
  • Traiter les commandes des clients et effectuer le suivi de la facturation des ventes.
  • Mettre en place le reporting commercial, sortir les statistiques de ventes périodiques par produit et par marché.
  • Organiser et suivre les plannings promotionnels.
  • Participer à l’organisation d’événements orientés client (ex: portes ouvertes) et de salons commerciaux.
  • Organiser et assister aux réunions commerciales pour en assurer leur efficacité.
  • Assister les démarches commerciales de terrain en étant le relais au sein de la brasserie.
Profil :
  • Vous êtes passionné(e) par le monde brassicole.
  • Vous démontrez d’excellentes aptitudes communicationnelles et relationnelles.
  • Vous parlez couramment le français et pouvez vous exprimer aisément en Néerlandais et en Anglais.
  • Vous êtes reconnu(e) pour votre rigueur, votre autonomie, votre sens du service, votre diplomatie et vos compétences organisationnelles.
  • Vous maîtrisez la suite Microsoft Office. Une expérience avec un ERP/CRM constitue un atout.
Offre :
  • Une fonction diversifiée au sein d’une entreprise familiale et conviviale.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil, à votre niveau d’expérience et au contexte.

Junior Product Specialist - Medical Device - Liège

Headquartered in Liège, Dim3 develops and markets innovative eHealth software and devices in the area of Clinical nutrition to facilitate medical decisions and enhance the life of patients.

Dim3’s technologies bring a great knowledge of healthcare and clinical biometry together with disruptive 3D scanning and software engineering experience. Dim3’s clinical nutrition management tools and connected products integrate automatic medical data collection, interpretation and visualization to give healthcare professionals clear and objective information in real-time.

For more information, please visit: www.dim3.com

In order to support Dim3’s development, we are actively looking for a (m/f):

Junior Product Specialist

Responsibilities:

As a Junior Product Specialist, you guide Dim3’s products to even higher levels. You have a key role in the team. You deal with medical practitioners, customers and partners in order to determine the future direction of Dim3’s applications including specific features, functionality and business models. You deeply understand the pains patients feel and invent ways to translate their needs into smart software. In order to take on these responsibilities successfully, you’ll benefit from broad training and individual coaching.

Reporting to the CTO, you work in close cooperation with customers, the Management Team, Product Development, Clinical Affairs and Sales. Your main responsibilities are:

  • You initiate the product roadmap and strategy in line with market needs and business priorities.
  • You define the pricing strategy and constantly analyze market trends and competitors’ evolution.
  • You support the Sales team in analyzing customers project requirements, in defining adapted technical solutions, and in developing written and oral commercial proposals.
  • You define new products specifications or improvements in an efficient way.
  • You manage the release process in collaboration with the other departments.
  • You develop adapted local marketing tools and actions.
  • report work evolution on a regular basis.
Profile:
  • Master’s degree in Business, Engineering or equivalent through experience.
  • Ideally first level experience in Product Management. Experience in medical software and/or devices is a plus. Experience in nutrition is also an asset. New graduates are also welcome.
  • Results and customer oriented, rigorous, autonomous and flexible.
  • Analytical, organized, team player, open-minded with a start-up mind-set.
  • Fluent in English. The command of French or any other language is an asset.
  • Strong oral and written communication.
  • Willing to travel for short periods (20% of your time) on a regular basis.
Offer:
  • A challenging position with direct impact on patients’ health and quality of life.
  • The opportunity to jump into an innovative medical software engineering company, a fast-growing start-up environment where teamwork, results and patient care are very important.
  • Varied contacts with professionals on an international scale.
  • Coaching and training path adapted to your needs.
  • An attractive salary package and evolution opportunities.

Flow Cytometry Specialist - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences, a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium), offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical samples.

Caprion operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotechs.

For its site in Gosselies and in the context of its growing immune monitoring service offering, Caprion is looking for a (m/f) :

Flow Cytometry Specialist

Responsibilities :

Reporting to the Laboratory Manager and working closely with Principal Scientists, the Flow Cytometry Specialist will work within a team focusing on the characterization of the immune response.

Tasks include :

  • Ensure that efficient and technically suitable cytometry systems and procedures are implemented in the laboratory, including instrument calibration and maintenance, flow cytometry-related SOP and forms, maintenance contracts, etc.;
  • Ensure that flow cytometer-related procedures are properly followed by the users;
  • Train, supervise and mentor laboratory personnel using the flow cytometry platform;
  • Prepare the flow cytometry settings and perform data acquisition as needed;
  • Support the Research Assistants for the troubleshooting of acquisitions;
  • Lead the on-site implementation of multisite procedures, QC, inter-equipment qualification and proficiency testing;
  • Act as a technical resource for the analysis of cytometry data;
  • Provide proposals for the design of complex antibody cocktails to the scientific team;
  • Write SOP and CSP as required;
  • Maintain instrument-related documentation as per GLP/GCLP and regulatory requirements and guidance;
  • Document and manage in a timely manner the instrument malfunctions and the deviations linked to cytometry operations;
  • Interact with vendors and field service engineers;
  • Participate in the preparation and conduct of client or regulatory body audits.
Profile :

The applicant must hold a master’s degree (or the equivalent) or a Ph.D. in a life science discipline such as biology, medical biology or biochemistry/biotechnology and a minimum of 4 years of recent and relevant cytometry experience.

The applicant must :

  • Demonstrate thorough knowledge of LSR and Fortessa cytometer voltage and compensation settings;
  • Be proficient with flow cytometry softwares such as Diva and FlowJo.;
  • Have a good knowledge of complex multiparametric panel design;
  • Demonstrate excellent organisational skills and ability to prioritize tasks;
  • Demonstrate schedule adaptability and flexibility;
  • Demonstrate excellent problem-solving skill;
  • Demonstrate ability to work in a multi-tasking and fast-paced environment;
  • Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes;
  • Demonstrate ability to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP);
  • Have a knowledge of flow cytometry proficiency programs;
  • Be functional in French (spoken and written) and have a functional knowledge of written English. Knowledge of spoken English is an asset.
Offer :
  • Full time permanent contract, with possibility of rapid start.
  • Diversified tasks and responsibilities and interesting projects.
  • A professional, dynamic and stimulating work environment.
  • Training and development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.