Production Technician
Key responsibilities:
· Conduct high-quality experiments according to applicable procedures or protocols
· Maintain excellent records related to his/her job
· Report the results to his/her supervisor
· Manufacture of products in accordance with the appropriate procedures and methods
· Maintenance of stock levels and records
· Protection of products / materials against spoilage / deterioration
· Maintenance, calibration, and testing of laboratory equipment
· Process Validation (current and new products)
· Maintenance of lab coats and equipment,
· Take reasonable care of the health and safety of themselves and of other persons who may be affected by their actions or omissions.
· Participate and comply with the Quality Management System.
· Maintain high technical skills and if necessary, acquired new competences.
· Participate in general laboratory organization, storage, and cleanliness.
· To order routine laboratory consumables.
· To order waste pick-up.
· Other ancillary tasks
Your profile:
· Bachelor or Master’s degree in a biological/chemical field and/or experience in design and conducting experimental laboratory work
· Fluent in French (spoken and written)
· Passive knowledge of English (Reading and understanding)
· Team worker
· Aptitude to work to respect timeline,
· Ability to work without supervision,
· Good organizational skills
· Problem-solving skills
Our offer:
· A varied and challenging job
· Permanent contract
· Full-time daytime (Monday – Friday)
· Pleasant working environment
· Attractive salary package
Company profile:
Volition is a multi-national epigenetics company developing simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases such as cancer and sepsis. Our mission is to save lives and improve outcomes for millions of people and animals worldwide.
Volition’s research and development activities are centered at Créalys Science Park in Gembloux, Belgium, with an innovation laboratory in San Diego, California and additional offices in Texas, London, and Singapore, as the company focuses on bringing its diagnostic products to market.
Interested? Please send your application, including CV and cover letter, to careers@volition.com
Your application will be handled quickly and confidentially.
French Version:
Volition est une entreprise multinationale spécialisée en épigénétique qui développe des tests sanguins rapides, simples et faciles à utiliser, visant à aider au diagnostic et au suivi de diverses maladies graves telles que le cancer et la septicémie. Notre mission est de sauver des vies et d’améliorer les résultats pour des millions de personnes et d’animaux à travers le monde.
Les activités de recherche et développement de Volition sont principalement basées au parc scientifique Créalys à Gembloux, en Belgique. L’entreprise dispose également d’un laboratoire à San Diego, en Californie, ainsi que de bureaux supplémentaires au Texas, à Londres et à Singapour, dans le cadre de sa stratégie de mise sur le marché de ses produits de diagnostic.
Description du poste
Nous recherchons un.e Technicien.ne de production pour rejoindre notre équipe à temps plein.
Ce poste est basé sur site à Gembloux, où vous travaillerez en étroite collaboration avec d’autres équipes pour garantir la qualité et l’efficacité de nos processus de production.
En tant que membre de l’équipe de production de Volition, votre rôle comprendra :
· Réaliser des expériences conformément aux procédures ou protocoles applicables
· Tenir des rapports d’expérience précis et complets relatifs à ses tâches
· Rapporter les résultats à son/sa supérieur(e)
· Aider à la gestion des niveaux de stock des consommables de laboratoire courants
· Protéger les produits/matériaux contre la détérioration ou l’altération
· Assurer l’entretien, la calibration et les tests des équipements de laboratoire
· Participer à la validation des procédés (produits actuels et nouveaux)
· Participer et se conformer au système qualité
· Participer à l’organisation générale du laboratoire, au rangement et à la propreté
· Réaliser d’autres tâches annexes
Qualifications
· Bachelier ou Master dans un domaine biologique ou chimique et/ou expérience dans la conception et la réalisation de travaux expérimentaux en laboratoire
· Maîtrise du français (oral et écrit)
· Connaissance passive de l’anglais (lecture et compréhension)
· Capacité à travailler en équipe
· Aptitude à respecter les délais
· Capacité à travailler de manière autonome
· Bonnes compétences organisationnelles
· Aptitude à résoudre les problèmes
Notre offre
· Un contrat à durée indéterminée (CDI)
· Temps plein (Lundi au vendredi)
· Horaires flexibles
· 20 congés annuels et 12 RTT par an
· Chèques-repas
· Eco-chèques
· Frais de déplacement
· Bonus sur objectifs personnels
· Bonus sur objectifs collectifs (CCT 90)
· Pécule de vacances
· Prime de fin d’année
Envoyez votre candidature (CV et lettre de motivation) à l’adresse careers@volition.com
Product Development Specialist
Department: Quality Assurance Department
Reports to: QA/RA Director
Responsibility for: The Product Development Specialist manages and coordinates the complete Product development process from the proof of concept to the industrialization of the product.
Goal of function: The Product Development Specialist manages and coordinates the complete product development process from the proof of concept to the industrialization of the product.
Main responsibilities and tasks:
Product development:
· Manage and coordinate product development projects, in collaboration with the different departments involved
· Follow up on product development project tasks and provide expertise for the review of the project deliverables
· Hold meetings to monitor product development projects and give regular reports on progress to Top Management
· Ensure that every phase and deliverables of the product development projects are made according to the applicable regulations and standards, and proceed as scheduled
· Carry out an active regulatory watch related to product development in collaboration with the QA/RA department
· Maintain the technical documentation up-to-date together with the QA/RA department
· Coordinate risk management on all products and maintain up-to-date Risk management files
Product management:
· Provide support for the Post Marketing Surveillance of the products already on the market.
· Manage in collaboration with the QA department the changes made to the products already on the market (change control)
· Support with his/her expertise the Process Validation of the new processes in development in production
Links to other departments: all departments
Decision making autonomy: management of the product development projects
Requested job skills:
Training and/or Education experience:
· Master’s degree in a scientific or engineering field
· Proven experience in Project management
· At least 2 years’ experience in the IVD industry, preferably in product development
· Proven experience in immunoassay development – Excellent knowledge of IVDR (2017/746)
· Good knowledge of ISO 14971
· Knowledge of ISO 13485 and FDA is an asset
· Fluent in English and in French
· Good knowledge of Microsoft Office
Soft skills:
· Excellent project management and interpersonal communication skills
· Team worker and federating skills
· Problem solving and decision making
· Assertive, flexible and persuasive
Working environment: Office (100%) – partial homeworking accepted
Quality Assistant
Department: QA/RA Department
Reports to: Quality Manager (N+2 = QA/RA Director)
Responsibility for:The management of the Quality System together with the QA/RA departement
Goal of function: The Quality Assistant works with the Quality Manager to maintain and establish procedures and quality standards and to monitor these ones against the company quality policy and objectives.
Main responsibilities and tasks:
· Assist the Quality Manager to maintain the conformity and adequacy the QMS procedures and related documents.
· Ensure with the Quality Manager the improvement and the management of the QMS key processes (Nonconformities, CAPA, complaints, internal audits, KPIs and data analysis, risk management, change control…)
· Participate actively to audits and help the follow-up of related actions.
· Participate to the yearly supplier evaluation
· Ensure trainings and awareness given by the quality assurance department.
· Ensure the follow-up of the equipment and infrastructure qualification as well as the personnel qualification.
· Assist the Product Development Specialist in the document management during the product design process.
· Ensure the update of the technical documentation related to the products on the market and help to the review of the Post Marketing Surveillance
· Review the batch records and participate to the batch release.
Links to other departments: All departments
Requested job skills:
Training and/or Education experience:
· Bachelor’s or master’s degree in a scientific field
· One or two years experience in Quality assurance is a plus
· Good knowledge of international standards applicable to the IVD field (ISO 13485, IVDR)
· Knowledge of risk analysis and ISO 14971 is a plus
· Experience in quality management systems
· Fluent in English and French
Soft skills:
· Good communication skills
· Good Office suite skills (Word, Excel, Powerpoint)
· Rigorous and with attention to details
· Good at analyzing information
· Problem solving and customer oriented
· Organizational and team working skills
Working environment: Office
