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Operations and Supply Chain

6 results

Maintenance and Test Engineer - 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):

Maintenance and Test Engineer

Responsibilities:

Reporting to the R&D Director, you support all maintenance and test activities and ensure that processes, procedures and controls are adapted to the operational needs. Your main responsibilities are:

  • You organize and perform the service and maintenance of consoles.
  • You create and enhance cases and perform verification tests.
  • You manage and calibrate test equipment.
  • You conduct first article inspections.
  • You generate and review quality and technical related documents.
  • You report results and work evolution on a regular basis to your line manager.
Profile:
  • Hands-on experience with electronics, mechanics and/or mechatronics. Experience in the Medical Device industry or in another highly regulated industry is a plus.
  • Strong communication skills together with hands-on and pragmatic mind-set.
  • Very good organizational, analytical and problem-solving skills.
  • Ability to work in a fast-paced, highly integrated team environment where accuracy, accountability quality, safety and timeliness are essential.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Good oral and written communication skills in English. Any other language is a plus.
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.
  • An attractive compensation package in line with the position responsibilities and your experience.

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.

Head of Operations – Microbial Therapeutics - Biotechnology - Brabant wallon

A-MANSIA is a biotech company focusing on microbiome therapeutics addressing human health issues like obesity and related disorders.

The mission of A-MANSIA is to provide innovative solutions based on Microbiome Therapeutics. Under the implementation plan in the Walloon Brabant province, its future development and reinforced by its 21 million euros fundraising success, A-Mansia is searching for a dynamic and enthusiastic person to strengthen the team. For more information about the company and the technology, please contact us via recruitment@pahrtners.be.

A-Mansia offers a French, Dutch and English-speaking environment, culturally diversified and located in the heart of Europe, in Belgium, few hours from European Capitals.

To strengthen the team in Mont-Saint-Guibert, we’re looking for an (m/f):

Head of Operations – Microbial Therapeutics

Main responsibilities:

Reporting directly to the CTO or to the CEO (depending on your experience), you are in charge of the whole production management for the fermentation process starting from sourcing of raw materials to commercialisation of finished products. You are the point of contact with the CMO(s) in charge of the finished products’ outsourced manufacturing of microbial products.

Your main tasks are:

  • Lead production projects and product launch on the market: sourcing of raw materials with the CMO, logistic, galenic development & packaging.
  • Coordinate the whole outsourced production and supply chain.
  • Define specifications, negotiate contracts and manage the collaboration with the CMOs and third parties.
  • Verify the raw materials’ compliance and control outsourced performances.
  • Control and lead the Cog’s at the product launch and on a long-term basis.
  • Be in charge of the internal supply chain team.
  • Report appropriately the progress of undertaken steps in an adapted manner.
Profile:
  • You hold a Ph.D. or you are engineer in Nutrition or Life Sciences, or equivalent by experience.
  • You have at least 5 years of industrial experience in production management related to the production of probiotics/ food complements.
  • You have experience and knowledge in fermentation process(es).
  • You have hands on experience in or knowledge of managing CMO’s and third parties.
  • You have skills in managing projects about launching food complements on the market.
  • You take advantages of an extended network on the industrial level and strong leadership.
  • You are rigorous, flexible, hands-on, independent, dynamic and pro-active.
  • You are fluent in English. The command of French and/or Dutch is an asset.
Offer :
  • A diversified position within a young and growing start-up.
  • A key position for the development of the company.
  • The opportunity to join a human sized, dynamic and professional environment.
  • A permanent employment contract.
  • An attractive compensation package in line with your experience.

Responsable de Production – Radio-Pharma - Radio–Pharma - Fleurus

Situées à Fleurus (Belgique), l’IRE et sa filiale IRE ELiT sont des entreprises industrielles renommées et innovantes.

Avec plus de 185 collaborateurs, l’IRE est un des principaux producteurs mondiaux de radio-isotopes utilisés en médecine nucléaire à des fins de diagnostic et de thérapie. IRE ELiT est active dans la protection de l’environnement et dans la production radio-pharmaceutique.

Ces entreprises contribuent à la santé de millions de patients dans le monde chaque année. Sur les 5 dernières années, l’entreprise a renforcé son développement et jouit d’une croissance continue. Veuillez consulter www.ire.eu.

Pour assurer le bon développement de l’IRE ELiT, nous sommes activement à la recherche d’un (m/f) :

Responsable de Production – Radio-Pharma

Responsabilités :

Rapportant au Directeur des Opérations, vous avez la responsabilité de la partie industrielle de l’IRE ELiT. Vous implémentez la stratégie de l’entreprise : vous coordonnez les opérations de production, d’entreposage, d’approvisionnement et de distribution des produits, tout en veillant au respect des normes de qualité. Le plan d’affaire de la société prévoyant une importante croissance dans les années à venir, vous aurez la responsabilité d’assurer la capacité industrielle suffisante de telle sorte que l’approvisionnement du marché soit garanti en quantité, délais et qualité.

Les responsabilités suivantes vous sont confiées :

  • Coordonner et optimiser le fonctionnement de la production radio-pharmaceutique.
  • Diriger, motiver et développer les collaborateurs de l’équipe.
  • Mettre en œuvre la stratégie de l’entreprise au sein des opérations.
  • Veiller au respect des normes de qualité dans un environnement GMP de production de médicaments stériles injectables, et au respect des normes environnementales et de sécurité.
  • Mettre en œuvre une politique d’amélioration continue et d’optimisation des investissements.
  • Planifier et contrôler l’évolution du budget, accompagné par le département financier.
  • Interagir, en tant que principal point de contact, avec les institutions externes.
  • Rapporter de manière structurée, rigoureuse et adaptée les résultats des activités.
Profil :
  • Vous êtes titulaire d’un Master en Pharmacie, Chimie, Biotechnologie, Ingénieur ou équivalent.
  • Vous disposez de minimum 7 années d’expérience dans une fonction comparable au sein d’un environnement GMP aseptique.
  • Vous avez, par votre expérience ou vos formations antérieures, un intérêt marqué et des connaissances de bases généralistes en business management (finance, marketing, stratégie, gestion des opérations…).
  • Vous démontrez de l’aisance dans la gestion d’équipe et de projets.
  • Vous communiquez efficacement, avec assertivité, et possédez une certaine aisance relationnelle.
  • Vous possédez une bonne connaissance du français et de l’anglais.
  • Vous êtes polyvalent, autonome, organisé et rigoureux.
  • La connaissance des outils du LEAN Manufacturing est un sérieux atout.
Offre :
  • Une fonction stimulante et diversifiée incluant des responsabilités et des projets intéressants.
  • Des défis professionnels, financiers et humains stimulants et enrichissants.
  • Des contacts variés avec des acteurs majeurs de l’industrie.
  • L’opportunité de renforcer une structure industrielle renommée, innovante et en forte croissance.
  • Un salaire attractif reprenant des avantages extra-légaux, en phase avec votre expérience.

Program Management Officer - Biotechnology - Gosselies

Located in Gosselies (Belgium), MaSTherCell is a service company (CDMO) in biotechnology. MaSTherCell is specialized in production outsourcing, process development and quality management (QA/QC/QP) for cell therapy.

With around 140 employees, MaSTherCell supports its customers (big pharma, biotech, etc.) in the development and production of innovative medicines. MaSTherCell actively contributes to improving the quality of life and health of many patients. For more information, please visit http://www.masthercell.com.

To support MaSTherCell in its strong growth, we are actively looking for a (m/f):

Program Management Officer
Responsibilities:

Reporting to the Executive committee, you assist them in selecting and planning strategic internal projects/programs (including new sites integration), and in reporting on their progress.

Your main responsibilities are:

  • You implement project management tools, project control processes, procedures and policies.
  • You monitor and control the internal program/project throughout their entire lifecycle.
  • You select program/project and you argue program/project closedown if necessary.
  • You assess the relative priority of internal projects and programs.
  • You set up performance reporting and program/project governance for customer and internal projects.
  • You lead the project financial tracking with the business controller.
  • You provide support to project teams and task planning.
  • You report your work on a regular basis.
 Profile:
  • Master’s degree or equivalent through experience.
  • Minimum 5 years experience in a project management officer position.
  • A project management professional certification is an asset.
  • Strong communication skills together with hands-on and pragmatic mind-set.
  • Very good organizational, analytical and problem-solving skills.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Good oral and written communication skills in English. Any other language is a plus.
  • Computer skills:  Microsoft office, Digital document management system and Project management IT tools.
Offer:
  • A challenging and diversified position within a high-potential innovative biotech company.
  • To work in a human size, dynamic, respectful and professional environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position responsibilities and your experience.

Product Design and Process Development Manager - 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):

Product Design and Process Development Manager

Responsibilities :

As Product Design & Process Development Manager, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, production of non GMP batches. You ensure the work is performed in compliance with Quality 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 the non-GMP productions.
  • Manage all drug substance and drug product activities of technology transfer to GMP unit.
  • Identify, select and oversight subcontractor for process optimization, non-GMP manufacture of Drug Substance (API) and Drug Product (DP).
  • Deliver robust, scalable, industrialisable and cost-effective manufacturing routes.
  • 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.
  • Supports, informs and aligns with cross functional project management team members such as preclinical development, QC, QA, RA units.
Profile :
  • Master degree or PhD in science, bioengineering or related.
  • At least 5 years relevant experience in a pharmaceutical or biotech environment.
  • Relevant expertise in lab techniques focused on protein purification and analysis..
  • Thorough knowledge of relevant FDA and EMEA regulations is an asset.
  • 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.

Other career opportunities

40 results

Medical Officer - Biotech, Biotechnology - Mont-Saint-Guibert

NOVADIP BIOSCIENCES (www.NOVADIP.com) is an innovative biotech company expert in the development of novel regenerative medicines. This human-sized structure is a leader in new generation therapies for hard & soft tissue reconstruction from autologous adipose stem cells.

NOVADIP BIOSCIENCES shows the ambition to grow to a worldwide class, with a successful closing of a 28M€ fund raising. Its main objective for the coming years is to develop its portfolio of products and to perform clinical validation and process industrialization of its main compounds.

NOVADIP BIOSCIENCES is a French/English-speaking work environment based in Mont-Saint-Guibert (close to University of Louvain-la-Neuve and Brussels area), Belgium, Europe.

In order to support our clinical development, we are actively looking for a (m/f):

Medical Officer

Responsibilities:

As a Medical Officer, you are part of the Medical Department consisting of the Chief Medical Officer, a Compliance Manager, 2 Clinical Project Managers, 2 Clinical Research Associates and a Clinical Research Assistant. You closely collaborate with them.

Your main responsibilities are as follows:

  • Design, contribute and write new study protocols and documentation related to clinical trials (IMPD/IND, investigator brochure, sponsor master files, patient informed consent, CRF, monitoring plan, safety plan /DSMB…) and contribute to the design of clinical development plans.
  • Develop and maintain a network of medical experts in the field and work in close collaboration with internal departments (i.e. R&D, Regulatory Affairs, Manufacturing, logistics…).
  • Identify, screen, select, initiate clinical sites, CROs, and other sub-contractors in the future trials in collaboration with clinical team.
  • Set up pharmacovigilance program (standalone or in collaboration with CRO).
  • Manage the interactions with ethics committees.
  • Monitor trials from a medical point of view, together with internal staff and clinical sites personnel.
  • Review incoming clinical data, and write medical reports or any other scientific files in collaboration with the Chief Medical Officer.
  • Facilitate communication flow between the clinical sites, CROs and Novadip.
  • Share your knowledge with the teams in order to overcome scientific, operational, regulatory, marketing, financial and strategic challenges within the company.
  • Active participation in training/coaching of operational teams involved in clinical trials (internal and external).
  • Report to the Chief Medical Officer.
Profile:
  • MD, PhD in Medical Sciences or Master in sciences or related field.
  • Min. 5 years of experience within either a CRO or a Pharma/Biotech/Medtech company. Experience in cell therapy is a great asset.
  • In depth understanding of clinical development plans, clinical trials, and superior knowledge of IHC-GCP.
  • Interest in basic sciences and translation of medical science in new clinical trials protocols.
  • Good communication skills with both clinical and non-clinical contacts.
  • Excellent attention to details and established organizational skills.
  • Demonstration of flexibility, professionalism, good interpersonal skills and managerial skills.
  • Fluency in written and spoken English is required. Good level of Dutch or French is desired.
  • Willingness and ability to be based in Belgium and to travel nationally and internationally.
  • To be in the possession of a full driving license.
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.
  • Varied contacts inside the company and with the biotech/pharma sector.
  • An attractive salary package in line with the position responsibilities and your experience.

Clinical Trial Manager - Biotechnology - Gosselies

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication.

For more information about the company, please contact us via recruitment@pahrtners.be

Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):

Clinical Trial Manager

Responsibilities:

Reporting directly to the Director of Clinical Operations and working closely with the team in Spain, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.

Your main responsibilities are:

  • Coordinate clinical trial in collaboration with selected CRO.
  • Visit clinical study sites regularly and interact with study members.
  • Ensure successful execution of the clinical trials on time and on budget.
  • Review study related documentation and materials.
  • Co-monitor clinical study for protocol adherence and safety with selected CRO.
  • Ensure that clinical trial activities are documented in accordance with regulatory requirement.
  • Create and maintain effective relationships with KOL.
  • Report results and work evolution on a regular basis to the Director of Clinical Operations.
Profile:
  • Master’s or bachelor’s degree in Life Science or equivalent through experience.
  • At least 5 years of relevant experience in clinical trials.
  • Extensive knowledge of all aspects of GCP and regulations.
  • Track record on managing clinical studies on time & on budget.
  • Good collaboration, documentation and presentation skills.
  • Flexibility, good time management, team-working skills, stress resistant, ability to work proactively and independently.
  • Well-developed communication skills, problem solving skills, creative and critical thinking.
  • Excellent command of Microsoft Office Tools (Excel, Word, PowerPoint).
  • Fluent in English. A good command of French or Catalan is an asset.
  • Prepared to travel to Spanish site regularly, clinical investigational sites, conferences and meeting with regulators.
Offer:
  • An interesting position within a high-potential clinical stage biotech company.
  • The opportunity to work in a human-sized and multicultural team environment.
  • A variety of interesting contacts with international exposure.
  • An attractive salary package in line with the position responsibilities and your experience.

Interested ?

Ingénieur Commercial - 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

Responsabilités :

En tant qu’Ingénieur Commercial, 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 êtes fraichement diplômé(e) ou possédez une première expérience 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.

Pharmacien d’Industrie (QP) - Bio-Pharma/Biotech - Woluwé-Saint-Lambert

Située à Woluwe-Saint-Lambert, ß+ Pharma est une société spécialisée dans la production de radio-isotopes innovants à usage médical et destinés au diagnostic de maladies oncologiques, cardiologiques et neurologiques. Sa production couvre les besoins de ses clients sur le territoire du BeNeLux et une partie de la France.

Fondée en 2002 et composée de 11 collaborateurs, ß+ Pharma offre un environnement dynamique et un réel esprit d’équipe permettant l’épanouissement de tous ses employés.

ß+ Pharma est une spin-out de la société IBA, dont elle utilise la technologie pour la production des radio-isotopes. Actuellement, la société fait partie du groupe Curium Pharma, actionnaire à 75%.

Afin de contribuer au développement de ß+ Pharma, nous sommes activement à la recherche d’un (h/f):

Pharmacien d’Industrie (QP)

Responsabilités:

En tant que Pharmacien d’Industrie (QP), vous supervisez la production des radio-pharmaceutiques dans le respect des normes GMP et vous assurez la libération des lots. Vous rapportez directement au Radio Pharmacien Responsable.

Vos principales tâches sont :

  • Libérer les lots produits en veillant à respecter les délais et les normes de qualité.
  • Participer aux activités de fabrication des radio-pharmaceutiques.
  • Assurer le bon fonctionnement des activités de maintenance, de qualification, de validation et

    d’approvisionnement du service.

  • Effectuer, en collaboration avec le Responsable QC, le suivi de contrôle des matières premières.
  • Gérer le système de qualité en accord avec les normes GMP.
  • Participer aux audits fournisseurs ainsi qu’aux audits sur les autres sites de production européens.
  • Participer à la formation initiale et continue du personnel.
  • Rapporter de manière régulière votre travail.
Profil:
  • Vous disposez d’un Master en Pharmacie, d’un Master complémentaire en Pharmacie Industrielle ainsi que d’un numéro QP.
  • Vous êtes fraichement diplômé(e) ou démontrez une première expérience dans le domaine en industrie (radio-/bio-)pharmaceutique.
  • Vous êtes respectueux(se), digne de confiance et aimez le travail en équipe.
  • Vous êtes flexible et faites preuve de rigueur.
  • Vous êtes dynamique et proactif(ve) et disposez de bonnes capacités de communication.
  • Vous maitrisez l’anglais et le français à l’oral comme à l’écrit.
Offre:
  • Une fonction diversifiée au sein d’une société en développement.
  • L’opportunité de rejoindre un environnement à taille humaine, dynamique et professionnel.
  • Un parcours de formation dès l’entrée en fonction et tout au long de votre évolution.
  • Un contrat à durée indéterminé assorti d’un package salarial attractif.

Senior product engineer - 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 product engineer

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.

Développeur Firmware embarqué - Engineering - Luxembourg

Créée en 2008, ShifTech Engineering est une entreprise spécialisée dans le domaine de la préparation de moteur sur banc de puissance. Composée d’une équipe de 15 personnes, ShifTech Engineering est actuellement présente en Belgique, en France, au Luxembourg et en Chine, et jouit d’une renommée internationale pour la qualité de ses réalisations et services destinés aux particuliers. Pour plus d’informations sur l’entreprise, veuillez consulter www.shiftech.eu.

Shiftech Engineering développe depuis 3 ans un nouveau produit hardware. Celui-ci permet au préparateur du monde entier de lire puis d’écrire les données d’un calculateur moteur. Pour plus d’informations sur le produit, veuillez consulter www.autotuner-tool.com

Dans le cadre du renforcement de l’équipe de Shiftech Engineering au Luxembourg, nous sommes activement à la recherche d’un (m/f) :

Développeur Firmware embarqué

Responsabilités :

En collaboration avec le chef de projet et notre Ingénieur Firmware, vous participez aux activités de développement de l’outil Autotuner. Vos principales responsabilités sont :

  • Analyser, développer et améliorer le code C déjà existant suivant les développements de nouveaux calculateurs moteur.
  • Etre en charge du développement des scripts LUA suivant le protocole CAN de la voiture.
  • Rapporter et présenter de manière structurée, rigoureuse et adaptée les résultats des activités.
  • Effectuer du reverse engineering.
Profil :
  • Vous disposez d’un Master en IT ou électronique.
  • Vous jouissez, idéalement, de 3 à 5 années d’expérience dans une fonction de développement Firmware en milieu industriel ou équivalent.
  • Vous possédez une excellente maîtrise de Python et du langage C. La connaissance des scripts LUA et de FreeRTOS est un atout majeur.
  • Vous êtes à l’aise avec Git ou tout autre logiciel de gestion de sources.
  • Vous faites montre d’un bel intérêt pour l’esprit start-up qui encourage la créativité et l’innovation.
  • Vous aimez les challenges et vous montrez de réelles affinités pour les innovations technologiques.
  • Vous communiquez aisément en français et en anglais.
  • Vous êtes analytique, proactif(ve), autonome, organisé(e) et rigoureux(se).
Offre :
  • Une fonction technique diversifiée et stimulante dans une petite équipe jeune et dynamique.
  • Intégrer une structure en pleine expansion et de renommée dans le domaine automobile pour la qualité de ses services.
  • Un cadre de travail agréable et d’accès aisé, et la possibilité de homeworking.
  • Un contrat à durée indéterminée à temps plein au Luxembourg, à Redange-sur-Attert.
  • Des opportunités de formation et de développement.
  • Une offre salariale attrayante, assortie d’avantages extralégaux compétitifs comprenant entre autres une voiture de société.

Head of RA - 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 RA

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.

Développeur Firmware embarqué - Engineering - Perwez

Créée en 2008, ShifTech Engineering est une entreprise spécialisée dans le domaine de la préparation de moteur sur banc de puissance. Composée d’une équipe de 15 personnes, ShifTech Engineering est actuellement présente en Belgique, en France, au Luxembourg et en Chine, et jouit d’une renommée internationale pour la qualité de ses réalisations et services destinés aux particuliers. Pour plus d’informations sur l’entreprise, veuillez consulter www.shiftech.eu.

Shiftech Engineering développe depuis 3 ans un nouveau produit hardware. Celui-ci permet au préparateur du monde entier de lire puis d’écrire les données d’un calculateur moteur. Pour plus d’informations sur le produit, veuillez consulter www.autotuner-tool.com.

Dans le cadre du renforcement de l’équipe de Shiftech Engineering à Perwez, nous sommes activement à la recherche d’un (m/f) :

Développeur Firmware embarqué

Responsabilités :

En collaboration avec le chef de projet et notre Ingénieur Firmware, vous participez aux activités de développement de l’outil Autotuner. Vos principales responsabilités sont :

  • Analyser, développer et améliorer le code C déjà existant suivant les développements de nouveaux calculateurs moteur.
  • Etre en charge du développement des scripts LUA suivant le protocole CAN de la voiture.
  • Rapporter et présenter de manière structurée, rigoureuse et adaptée les résultats des activités.
  • Effectuer du reverse engineering.

Profil :

  • Vous disposez d’un Master en IT ou électronique.
  • Vous jouissez, idéalement, de 3 à 5 années d’expérience dans une fonction de développement Firmware en milieu industriel ou équivalent.
  • Vous possédez une excellente maîtrise de Python et du langage C. La connaissance des scripts LUA et de FreeRTOS est un atout majeur.
  • Vous êtes à l’aise avec Git ou tout autre logiciel de gestion de sources.
  • Vous faites montre d’un bel intérêt pour l’esprit start-up qui encourage la créativité et l’innovation.
  • Vous aimez les challenges et vous montrez de réelles affinités pour les innovations technologiques.
  • Vous communiquez aisément en français et en anglais.
  • Vous êtes analytique, proactif(ve), autonome, organisé(e) et rigoureux(se).

Offre :

  • Une fonction technique diversifiée et stimulante dans une petite équipe jeune et dynamique.
  • Intégrer une structure en pleine expansion et de renommée dans le domaine automobile pour la qualité de ses services.
  • Un cadre de travail agréable et d’accès aisé, et la possibilité de homeworking.
  • Un contrat à durée indéterminée à temps plein en Brabant Wallon, à Perwez.
  • Des opportunités de formation et de développement.
  • Une offre salariale attrayante, assortie d’avantages extralégaux compétitifs comprenant entre autres une voiture de société.

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.

Marketing Intelligence Manager - Food Services - Goé

Savencia Fromage & Dairy is one of the leading companies in the cheese and milk transformation activities in the world. Employing around 24,000 people, the Savencia group commercialises its production in 120 countries around the world.

In order to develop globalised solutions, Savencia Fromage & Dairy launches the Savencia Global Food Service System Solutions Business Unit. This business unit will help Savencia group to meet their clients’ needs in a global and even more efficient way.

To strengthen this new business unit, we are looking for a (m/f) Marketing Intelligence Manager, who will be located in Belgium.

Marketing Intelligence Manager

Main responsibilities:

As a Marketing Intelligence Manager, you have a strong impact on the Business Unit’s strategy and development results. You are in charge of all the Marketing aspects of the BU, covering the industrial bakery & pastry chains as well as the QSR & fast food casual chains.

Your main responsibilities are:

  • Ensure a worldwide continuous market analysis.
  • Co-operate with market intelligence specialists and regional marketing departments.
  • Conduct ad hoc analysis to get external view and market insights.
  • Review the company’s market position and determine new trends, opportunities and threats.
  • Participate to the budget and long-term plan definition. Recommend priority developments.
  • Define development strategies for global and strong regional key accounts.
  • Set-up and manage key business performance indicators.
  • Conduct global and regional projects.
  • Report work and results evolution on a regular basis to the top management.
Profile:
  • You hold a Master’s degree in Business or Engineering with MBA, or equivalent by experience.
  • You have at least 7 years of experience in marketing positions in Bakery/Pastery/QSR chains and/or in industrial ingredients companies.
  • You have a deep understanding of technical aspects in Bakery, Pastery and/or QSR activities.
  • You are autonomous, a self-driven and a result-oriented person.
  • You show strong analytical, leadership and communication skills.
  • You are rigorous, flexible, hands-on, dynamic and pro-active.
  • You are fluent in English. The command of any other European language is an asset.
Offer :
  • A diversified and strategic position in massive group within the food industry.
  • A key position for the development of the company.
  • The opportunity to join a human sized, dynamic and professional environment.
  • A permanent employment contract.
  • An attractive compensation package in line with your experience.