Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Bonnes connaissances des procédés de production Biotechnologiques (Upstream et/ou Downstream et/ou Logistique (Media/Buffer).
Bonnes connaissances des processus de nettoyage (CIP/COP), de stérilisation (SIP), d’environmental monitoring, de thermal mapping de zone à température contrôlée.
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Your responsibilities: As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant.
Drive the implementation of the new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.
Support management of materials & product specifications, execute incoming materials release
Support the consolidation and writing of the Contamination Control Strategy
Drive the supplier’s qualification program
Establish and drive the inspection readiness program
Drive the preparation of the new Gene Therapy Facility Site Master File
Your profile:
Scientific master’s degree or equivalent
At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment
Experience of a new manufacturing facility seeking Health Authorities certification
Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing
Experience in health authorities’ inspections
Strong Knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing
Fluency in English and French
QP Registration in Belgium is an asset
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk-based approach
Able to understand customers’ needs and technical requirements
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Quality System Contractor Contracting – Brabant-Walloon
Responsibilities?
Ensure the promotion of awareness of applicable regulatory and quality management system throughout the Braine Bio DS staff.
Support network initiatives related to quality and compliance for local implementation; act as connection for global initiatives related to quality and compliance for local implementation (including Regulatory Intelligence Network RIN).
Benchmark with external sources to understand industry trends and share with the department.
Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for the Braine Bio DS staff.
Lead and model behaviors foundation to strong Quality Culture with connection to operations (e.g., build training materials based on deficiencies noticed during gembas, etc.).
Ensure that adequate quality governance boards are implemented and provide direction (e.g., deviation review board, change control review board, etc.).
Develop appropriate tools to collect quality-related risks and ensure escalation as per companies quality management system.
Chair the Quality Council; develop relevant indicators to assess maturity level and propose action plan to ensure continuous improvement and improve Quality Culture.
Clarify roles and responsibilities and interactions with other functions involved in QMS. Ensure the voice of the Bio DS Quality Belgium team is accounted for.
Lead inspection readiness program.
Coordinate inspections or audits by regulatory authorities, companies Global Quality Auditing team, and others as needed (including development of responses).
Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
Implement best practices and innovative solutions to improve product quality and operational performance.
Make connection within companies organization to improve visibility and influence of the team (e.g., quality systems & strategy, internal manufacturing quality, global quality auditing).
Your profile
Minimum of 10 years’ experience in the pharmaceutical industry.
Demonstrated experience in quality system / quality compliance.
Demonstrated experience in audit and inspection.
Ability to collaborate and influence across departments and levels.
Fluent in French and English.
On-site presence required.
Additional Skills: Demonstrated experience in biological drug substance (businessand/or quality) to facilitate interactions with other teams. Ability to face unstable environment and demonstrate agility to handle unpredicted changes. Stress resistant.
Our offer Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Development of an in-depth understanding of the process chemistry and process engineering relating to the postholder's projects and an awareness ofchemical aspects of other projects within the group.
Execution of preliminary literature surveys leading to the definition of experimental programs. Planning, preparation and implementation of experimentaland/or scale-up studies using standard and specialized equipment and techniques(laboratory, kilo-lab & pilot plant). Initiation, monitoring and work-up of reactions aswell as isolation and purifications of materials (laboratory, kilo-lab and pilot scale).
Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optimum product quality. Submission ofmaterials for analysis and/or generation of analytical data using standard laboratoryanalyses. Interpretation of analytical results from these tests for laboratory, kilo-laband pilot activities.
Ensuring good record keeping with respect to all laboratory, kilo-laboratory and pilot plant activities, particularly regarding patentability & regulatory requirements.
Preparation of detailed reports covering specific work programs on completion of the activities or whenever appropriate. Preparation of high quality documentationin support of potential companies patent applications and other publications as requested.
Participation in the transfer of chemical processes from laboratory to kilo-lab, pilot plant and/or production, under the direction of Science lead.
Full compliance with all departmental and site-specific Health, Safety,
Environmental and Quality regulations, systems and procedures covering laboratoryand scale-up activities. Additional requirement of full compliance with all companies business policies and guidelines.
Participation in and active contribution to departmental and/or technical meetings as required. Responsibility for ensuring compliance with actions established during these meetings.
Participation in, contribution to and/or completion of other initiatives, tasks or activities as requested or assigned by the project/science lead, group head, or department Director from time to time
Your Profile
Knowledge in general organic chemistry both theoretical and practical;chromatography (HPLC/UPLC/GC) and characterization techniques (UV; PAT;NMR and MS spectrometry); Automatized equipment, typical lab equipment.
Knowledge in process analytical technology (PAT) for monitoring and characterization
Knowledge in crystallization process development and characterization
Ability to participate to process development as scientist in specific area of expertise as process characterization, optimization, understanding, industrialization and investigation QbD development of the different compounds in development.
Experience in ensuring that all developed processes can be scaled up to a 60 L reactor and perform the syntheses at this scale in the Kilolab.
Experience in transferring to the Pilot Plant is an asset
Understanding of regulatory environments
Good understanding of the results, good record keeping and reporting with respect to technical activities.
Ensure that all processes are in compliance with internal safety rules.
Ability to ensure a good literature survey on the projects by using all available research methods and tools.
Ability to find technical solutions and activate all appropriate internal /external experts to solve the issue
Ability to independently manage R&D tasks in order to meet deadlines within given constraints in resources, e.g. headcount, equipment, time, etc.
Demonstrated flexibility and agility to learn and acquire new competencies
Demonstrated ability to participate in the communication and information exchange
Demonstrated good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
Work transversally across projects and groups in line with the needs of the business and as part of the Drug Substance Process Sciences organization and wider CMC
Our offer Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Validate the integrity of transferred and transformed data in the new system.
Draft and execute validation protocols (tests, reports, documentation).
Define User Requirement Specifications (URS) and ensure compliance.
Collaborate with IT and business teams to guarantee data accuracy and consistency.
Manage a backlog of dashboards awaiting validation and ensure effective follow-up.
Communicate with various stakeholders (IT, Business, QA, QC).
Be proactive in coordinating tasks and following up with stakeholders.
Your profile:
Bachelor’s degree in Sciences
Proven experience in data validation, preferably in a regulated environment.
Strong proficiency in SQL for executing tests and validating data.
Skills in project management, stakeholder engagement, documentation and reporting.
Ability to work independently and within a team, with strong prioritization skills.
Experience in the pharmaceutical industry and knowledge of GMP standards (a plus).
Fluent in French and English
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Être un support HSE pour l’Engineering dans les gaps assessment Safety by design des activités à haut risques
Collaborer au déploiement et à la consolidation opérationnelle des activités à hauts risques
Être possiblement un support au service interne de sécurité (SIPP) dans ses missions légales (analyses de risques, analyses d’événements indésirables)
Être un partenaire/copilote de nos partenaires concernés pour assurer un déploiement efficace des requis opérationnels pour les activités à haut risques
Apporter un soutien à l’Engineering pour assurer un environnement optimal de santé et de sécurité et Bien-être pour les employés, la sécurité des équipements et des processus allant au-delà de la conformité (directives et exigences HSE et exigences légales).
Être un soutien solide au-delà d’un conseiller, dans la conduite d’une culture HSE positive et orientée vers l’action
Faire coïncider les requis légaux avec les attentes de nos partenaires
Votre profil?
Orientation ingénieur industriel technique
Connaissance de la législation belge en matière de sécurité au travail
Connaissance des directives techniques comme : Machine, PED, ATEX, levage,…
Lecture de l’anglais technique
Pratique de la sécurité en milieu industriel pharmaceutique
Pratique des évaluations techniques
Connaissances de l’environnement GMP
Orientée terrain et pragmatisme
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu’un package salarial attractif. Vous profiterez également de l’opportunité de vous développer personnellement et professionnellement à travers des formations internes. Intéressé(e) ? N’attendez plus !
Your responsibilities: Our client is looking for a Documentation & Training Coordinator for a major project aimed at modernizing the artwork management system. This role is crucial to ensure the update and finalization of associated documentation, as well as the coordination of training for users. The person hired will work closely with a dynamic project team.
Coordinate the update of documentation according to the new defined structure.
Support Subject Matter Experts (SMEs) to ensure the timely delivery of documents.
Monitor and manage the documentation schedule.
Plan and organize the user training program (300+ people).
Ensure adherence to the schedule and follow up with stakeholders in case of delays.
Coordinate the transition period between the old and new systems.
Ensure smooth communication with the various teams involved.
Your profile:
Bachelor's Degree in Sciences
Fluency in French and English, Dutch is a plus.
Experience in documentation coordination for large projects.
Excellent organizational skills and strong responsiveness.
Diplomacy and ability to bring stakeholders together.
Advanced proficiency in Excel and project management tools.
Project management experience (without being a Project Manager) is a plus.
Experience in the pharmaceutical or regulated industry is a plus but not required.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Votre mission : Notre client est à la recherche d’un Project Manager Engineering Capex à consonnance technique pour driver un de leurs projets clefs. Le projet concerne la distribution centralisée de solvant dans le bâtiment upstream. Il souhaite retirer les fûts de solvant de la zone de production et centraliser leur alimentation via des cuves tampons, et de manière automatisée. Le profil sélectionné devra être en mesure de :
Comprendre et driver les aspects techniques de ce projet (et leader une équipe composée de chimistes, process engineers, automation engineer, electrical engineer, EHS, QA technique…)
Mettre à jour le budget et le forecast du projet
Suivre et leader le planning du projet
Leader les achats (la négociation se faisant via le procurement manager),
Mettre en place une stratégie de construction, stratégie de commissioning et de qualification.
Votre profil :
Expérience avérée en gestion de projets CAPEX industriels, idéalement dans un environnement pharmaceutique, chimique ou biotechnologique.
Solide bagage technique en ingénierie des procédés, automatisation et équipements industriels.
Expérience en gestion d’équipes multidisciplinaires et en coordination de projets complexes.
Connaissance des normes EHS et QA applicables aux environnements de production.
Capacité à gérer un budget, un planning et à anticiper les risques.
Esprit de leadership, proactivité et forte autonomie.
Anglais professionnel requis.
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Understanding the specific needs of over 35 countries we operate in, balancing between standardization and local adaptation.
Translating these market requirements into clear supply chain processes.
Managing projects, coordinating with internal teams and external stakeholders.
Managing distribution processes, designing solutions that meet business and IT needs.
Ensuring smooth communication between business teams and IT departments, especially for market-specific solutions.
Leading Request for Proposals (RFP) processes with external partners and writing user stories when necessary.
Your profile:
Master’s degree in Sciences
Minimum of 5 years of experience in Supply Chain, ideally with expertise in distribution networks, supply chain management, and customer service management.
Fluent in English and French
Experience in Supply Chain Planning or Logistics role within pharma or food industry.
Good understanding of lean principles and methodologies.
Project management skills.
Ideally, experience in the pharmaceutical or a similar regulated industry, but experience in other industries (e.g. cosmetics, FMCG) could be considered.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
