QA Deviation Champion

  • Location: Braine l'Alleud
  • Job #25709

QA Deviation Champion

Contracting – Brabant Wallon

Vos responsabilités :

  • S’assurer du respect cGMP.
  • Participer à la gestion/revue/approbation des déviations.
  • Participer à la gestion/revue/approbation des CAPA.
  • Participer à la gestion/revue/approbation des change controls
  • Participer activement à la préparation des lots de process performance qualification (PPQ).
  • S’assurer que les risques/non conformités identifiées sont traités de manières adéquates et remontés dans les temps.

Votre profil :

  • Diplômé(e) de l’enseignement supérieur de type Bachelier ou Master (biotechnologie, pharmacie, etc.).
  • Expérience dans un environnement GMP.
  • Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA.
  • Bilingue en Français et Anglais.

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]
 

QA Operation Specialist

  • Location: Braine l'Alleud
  • Job #25708

QA Operation Specialist

Contracting – Brabant Wallon

Vos responsabilités :

  • S’assurer du respect cGMP.
  • Participer activement à la préparation des lots de process performance qualification (PPQ).
  • Revoir et approuver les dossiers de lot de production en version papier et électronique.
  • Participer à la gestion/revue/approbation des déviations.
  • Participer à la gestion/revue/approbation des CAPA.
  • Participer à la gestion/revue/approbation des change controls.
  • Revoir et approuver les protocoles et rapports de validation (CIP/SIP/EM/Thermal mapping).
  • S’assurer que les risques/non conformités identifiées sont traités de manières adéquates et remontés dans les temps.

Votre profil :

  • Diplômé(e) de l’enseignement supérieur de type Bachelier ou Master (biotechnologie, pharmacie, etc.).
  • Bilingue Français et Anglais.
  • Expérience dans un environnement GMP.
  • Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA.
  • 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]

 

Gene Therapy Quality Partner

  • Location: Braine l'Alleud
  • Job #25706

Gene Therapy Quality Partner

Contracting – Brabant Wallon

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

  • Location: Braine l'Alleud
  • Job #25705

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 (business and/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]
 

Process Scientist

  • Location: Braine l'Alleud
  • Job #25704

Process Scientist
Contracting – Brabant-Walloon

Responsibilities?

  • Development of an in-depth understanding of the process chemistry and process engineering relating to the postholder's projects and an awareness of chemical aspects of other projects within the group.
  • Execution of preliminary literature surveys leading to the definition of experimental programs. Planning, preparation and implementation of experimental and/or scale-up studies using standard and specialized equipment and techniques (laboratory, kilo-lab & pilot plant). Initiation, monitoring and work-up of reactions as well 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 of materials for analysis and/or generation of analytical data using standard laboratory analyses. Interpretation of analytical results from these tests for laboratory, kilo-lab and 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 documentation in 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]

Data Validation Specialist

  • Location: Braine l'Alleud
  • Job #25702

Data Validation Specialist

Contracting – Brabant Wallon

Your responsibilities:

  • 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]
 

HSE Support

  • Location: Braine-l'Alleud
  • Job #25700

HSE Support

Contracting – Brabant Wallon 

Vos responsabilités ?  

  • 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 !

 

Documentation Coordinator

  • Location: Braine l'Alleud
  • Job #25701

Documentation Coordinator

Contracting – Brabant Wallon

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]
 

Project Manager Engineering Capex

  • Location: Braine l'Alleud
  • Job #25685

Project Manager Engineering Capex

Contracting – Brabant Wallon

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]
 

Supply Chain Business Process Expert

  • Location: Braine l'Alleud
  • Job #25679

Supply Chain Business Process Expert

Contracting – Brabant Wallon

Your responsibilities:

  • 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]