Job Province: Walloon Brabant

QA Sterility

  • Location: Wavre
  • Job #26402

QA Sterility

Contracting – Brabant Wallon

Key Responsibilities:

  • Facilitate interactions between Global sterility assurance and the CMO under its responsibility by establishing working relationship (Service Level agreement using Key Performance Indicators) with the leaders and main contact people.
  • Act as a main point of contact for the CMO in supporting the implementation of the client Sterility Assurance Strategy
  • Is the point of contact for supporting the CMO in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road map
  • Support CMO in the execution of the annual CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects) and perform process confirmations on targeted topics
  • Partnership with CMO for Key Performance Indicators analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's and QMS, FDA Guidance, etc.)
  • Review with CMO the annual performance in Sterility Assurance and help on the preparation of the next CCS
  • Assure availability of Sterility Assurance experts for supporting CMO in a specific domain according to annual CCS priorities.
  • Accountable for alignment in way of working and standard works between CMO in Sterility Assurance subjects.
  • Is the Sterility Assurance quality generalist and therefore act as SPOC 9Single Point of Contact) in case of issue/question raised by the CMO.
  • External advocacy: Lead or influence proactively Sterility assurance external trade associations.
  • Developing Capability: Supporting the development of sterility assurance capability across key areas of the business through delivery of training, coaching and mentoring.

Why you?

  • Bachelor degree in a Scientific Discipline
  • Significant experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
  • In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files
  • Strong technical and quality skills in sterility assurance issue
  • Coaching and mentoring capabilities for shopfloor training and education
  • Strong verbal and written English language skills & French

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 Engineer

  • Location: Brabant Wallon
  • Job #26374

Process Engineer

Contracting – Brabant Wallon

Description des activités:

  • Déploie efficacement des projets en collaboration avec les différents acteurs en place, en assurant une coordination optimale et une synergie entre les équipes.
  • Développement de solutions scientifiques pour optimiser les processus
  • Identifier, analyser et gérer de manière proactive les risques associés au projet.
  • Organiser et leader le Steering Committees pour le projet, les PRB, les réunions d’alignement.
  • Développer et promouvoir une vision stratégique claire pour les projets, en tenant compte de l’évolution des besoins de l’entreprise.
  • Assurer une communication fluide et efficace au sein du projet ainsi qu’avec les stakeholders, en adaptant les messages selon les audiences.
  • Garantir le suivi des indicateurs de performance du projet et des projets associés
  • Piloter la gestion du budget du projet, en garantissant un suivi des dépenses et en élaborant des projections pour les années futures

Principaux projets :
1- Projet de validation et qualification d'une nouvelle tour de chromatographie (validation et qualification, implémentation de l'équipement en production)
2- Projet DOE élution allongée (test à petite échelle de l'effet cumulé des élutions allongées QXL HA sur le rendement et l'élimination des impuretés)

Votre profil:

  • Capacité démontrée à acquérir rapidement des connaissances sur des sujets nouveaux dans un environnement complexe et en constante évolution.
  • Capacité à faire valoir le positionnement scientifique basé sur des évidences.
  • Aptitude à s’intégrer facilement dans des équipes pluridisciplinaires et à collaborer avec des parties prenantes variées.
  • Expérience avérée dans la gestion de projets complexes, avec une expertise particulière dans les domaines du process et de la validation dans l’industrie pharmaceutique.
  • Proactivité et capacité à anticiper les besoins du projet, en prenant des initiatives pour garantir son succès.
  • Sens critique et capacité à gérer des priorités multiples dans un environnement dynamique.
  • Orientation résultats, avec un sens de l’organisation et de la gestion des délais.
  • Capacité à synthétiser les messages clés pour le management.

Notre offre :
Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Nous serons votre partenaire de carrière à chaque étape de votre parcours professionnel. Intéressé(e) par cette opportunité ? Nous vous invitons à postuler ou à m’envoyer directement votre CV à l’adresse suivante : [email protected]
 

Product & Process/Project Manager

  • Location: Wavre
  • Job #26244

Product & Process/Project Manager

Contracting – Brabant Wallon

Your responsibilities:

  • Ability to direct projects, manage different project phases and coordinate project team.
  • Responsibility for projects and assistance to stream lead and client.
  • Responsible for obtaining optimal results on completion of project achieving quality, performance, cost and scheduling requirements required in the specifications.
  • Has specialized technical or practical expertise in one or more areas and knowledge of project management software and method.

Your profile:

  • Experience in project management
  • Experience in Product & Process
  • Consultant is expected to follow and apply project management methodologies, tools and practices which are based on PMBOK Knowledge: · Demonstrates competency in project management software and methods
  • Successful experience in stakeholders management
  • Proven Project Management experience with capability of working independently on multiple projects, and ability to prioritize tasks and meet strict deadlines
  • Excellent organization skills and ability to operate effectively in a multicultural, matrix organization where the workload requires balancing multiple responsibilities simultaneously
  • Establish and maintain cross functional relationships. Develop relationships across organizational boundaries
  • Analytical, logical thought process with strong information organization/management skills.
  • University degree with experience in project management
  • Prince II, SAP, Suite office
  • French & 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]

 

Learning & Documentation Coordinator

  • Location: Braine-l'Alleud
  • Job #26213

Learning & Documentation Coordinator

Brabant Wallon – contracting 

What are your responsibilities?

  • Documentation & Learning lifecycle management:
  • Ensure the organization, maintenance and lifecycle management of controlled documents and training materials
  • Ensure compliance with applicable regulatory frameworks (GLP, GCP, Research Guidance, HTA, HBS, HSE, etc.) and internal standards

 

  • Process harmonization and continuous improvement
  • Support the design and implementation of streamlined, harmonized processes that integrate documentation and learning activities
  • Contribute to continuous improvement initiatives aimed at enhancing efficiency, simplification, compliance and user experience
  • Promote best practices and innovative solutions in documentation and learning management, fostering a harmonized, customer-focused, and outcome-driven culture

 

  • Regulated, non-Regulated & Controlled Document management
  • Act as the coordinator for the Regulated/Non-Regulated/Controlled Document management system, ensuring timely tracking, updates, reviews, and approvals of SOPs, guidance and related documents (based on regulatory changes, SME inputs, inspection finding or scheduled reviews)
  • Provide expert guidance to document owners and Patient Solutions staff on controlled document management best practices.
  • Ensure effective training and communication related to new or revised SOPs & associated documents, including timely withdrawal of obsolete documents

 

  • Training coordination
  • Support Patient Solutions employees and managers in meeting training requirements by maintaining accurate training plans, curricula and matrices
  • Ensure the availability and accessibility of training materials linked to controlled documents impacting Patient Solutions
  • Collaborate with the department learning lead and line managers to develop and maintain relevant training programs (plans, matrices, …).
  • Manage training records and documentation, including CVs, job descriptions, attendance logs, training registers, ….

 

  • Stakeholder engagement and support:
  • Serve as a key point of contact for all Learning & Documentation-related questions.
  • Manage and respond to requests received, including through the global PSol Learning & Documentation mailbox.
  • Audit & Inspection Readiness
  • Ensure operational readiness for internal and external inspections and audits related to documentation and learning.
  • Track and follow up on actions resulting from audit or inspection findings.

 

  • Performance Monitoring & Reporting
  • Collect, consolidate, and report key performance indicators and metrics related to documentation and training compliance.
  • Maintain and update the Learning & Documentation compliance dashboard.
  • Additional operational support
  • Provide support as needed to the Head of Internal Coordination, Learning & Sustainability Compliance in managing and reporting on broader initiatives, including sustainability, compliance, communication, intranet content, PMO dashboards, and objective tracking

Who are you? 

  • Relevant experience in GxP (GLP, GCP) regulations and within the pharmaceutical industry
  • Relevant experience in SOP /training and content management systems
  • Familiar with electronic document management systems (e.g., Veeva, SharePoint, or similar platforms) and Learning Management Systems (LMS) for training assignment, tracking, and reporting.
  • Languages skills: French and English
  • Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
  • Ability to collect, analyze, and develop visual reports, KPIs and compliance metrics.
  • Experience in dashboard creation and, potentially, in the use of communication tools
  • Detail-oriented with the ability to maintain a high-level perspective
  • Strong organizational, planning and coordination skills, with the ability to prioritize tasks, manage multiple responsibilities, and proactively adapt in an evolving environment
  • Ability to interact and collaborate with cross-functional teams and various stakeholders
  • Analytical mind, ability to make improvement suggestions and resolving issues
  • Project management and influencing skills

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.

 

QA Assistant

  • Location: Nivelles
  • Job #26171

QA Assistant 

Vos responsabilités ?  

  • Support à la Personne Qualifiée dans le cadre de l’activité de libération des produits pharmaceutiques (ex : Gestion des BMR (Batch Manufacturing Report), des BPR (batch packaging report) des Certificats d’analyse et certificats de conformité, préparation de la documentation relative au contrôle packaging.
  • Support au Pharmacien Responsable dans le cadre de la réception et distribution des médicaments.
  • Rédaction des rapports de température lors de la réception des conteneurs et lors de l’envoi de conteneurs
  • Support au département qualité dans la gestion du système de qualité (QMS) (gestion des documents papiers et informatiques)
  • Participe aux activités de routine et à l’amélioration continu du département QA
  • Assure un contact et un suivi avec les différents fournisseurs.
  • Assister dans les différents projets de développement de la société.

Votre profil?

  • Connaissance de l’environnement pharmaceutique et de sa réglementation et des guidances spécifiques (GMP, GDP …)
  • Une expérience dans un département qualité.
  • 2 ans d’expérience dans un environnement pharmaceutique industrie
  • Maitrise du français et de l’anglais au quotidien
  • Maitrise des outils informatique (Word, Excel, Outlook)  
  • Avoir un esprit critique et analytique
  • Excellent relationnel pouvant s’adapter à différentes cultures au niveau des affaires
  • Vous êtes une personne rigoureuse et méthodique
  • Vous avez le sens de l’ordre et de l’organisation

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 !
 

Process Engineer

  • Location: Wavre
  • Job #26170

Process Engineer
Brabant Walloon – contracting
Our partner is looking for a Process Engineer to join its team. This international company is well-known for its pharmaceuticals.
Your responsibilities?
In coordination with Engineering Office and Project Management, you will provide expertise in the implementation of good engineering & design practices and solutions to support design, execution and commissioning / qualification phases of CapEx Projects.
You will ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities’ requirement of Secondary equipment’s and Aseptic technologies package.
Related to these packages, it includes:

  • Being the internal representative for all Secondary equipment’s and Aseptic technologies-related activities and installations
  • Supporting the E.O in management of activities related to this package
  • Ensure regular technical contact with MPU representative (User, QA, Validation, Maintenance,…)
  • Ensuring alignment between E.O and the company Specification and Guidance
  • Reviewing design and technical documentation
  • Following-up construction & all testing activities falling under the package’ scope
  • Ensure systems start-up and punch list solving
  • Writing and executing commissioning and qualification protocols/reports
  • Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
  • Facilitating handover process towards the end user

Your profile?

  • Engineering degree with 7 years’ experience as Process Engineer in Secondary Equipment’s and Aseptic Technologies domains.
  • Strong Experience in the Pharmaceutical industry and cGMP environment. 
  • Definition of functional, technical and quality requirements.
  • Realization of reviews of process studies, P&ID’s and layout.
  • Oversight contractor’s performance.
  • Integration of operability and EHS requirements at all design steps.
  • Preparation of the project testing, commissioning and inspection requirements
  • Organize legal conformity visits
  • On-site verification of execution according to good practices
  • Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…) 

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. Do you have any questions? You can contact Anaïs Malikian, [email protected] 
 

QA External Supply

  • Location: Wavre
  • Job #26169

QA External Supply 

Brabant Wallon – contracting 

What are your responsibilities?

  • Be accountable for technical management including risk management, deviation ownership, change control authoring and coordinating, Product Technical Specification (PTS) and Method of Production (MOP) review and knowledge management. Participate to  CC Implementation committee.
  • Review and approve demand versus supply, assess the capacity available, identify potential risks to service and identify requirements to capacity adjustments to meet future volume projections. Give, understand and master the inputs/outputs of SRM meeting.
  • Ensure visibility is given on demand and supply information across the supply chain to ensure pro-active management and avoid out of stocks, performance management through set-up, measurement, monitoring and reporting of KPI’s
  • Drive continuous improvement projects with his/her CMO and with internal and external stakeholders in order to strengthen the CMO operational activities. Support continuous improvement for complex/transversal projects.
  • Give support to the QA team to ensure compliance of the ES operations with cGMP and Authorities requirements.
  • Timely escalate issues to Manager if required by internal process
  • Be accountable for reporting (KPI, monthly)

  • Be the back up of the SRM (Supplier Relationship Manager

    Who are you ? 

  • Experience (preferable 1-3 years) in the following :
    • (Bio)pharma & cGMP
    • Quality
    • Project management
  • Bilingual French/English (oral & written)
  • Proactive with ability to identify and follow up on gaps in process
  • Ability to work under pressure due to the requested flexibility and reactivity of the activities
  • Be able to manage short term issues with long term activities in parallel.
  • Ability to work in project teams in a multidisciplinary environment and a matrixial organization
  • Be able to lead and manage cross-functional projects
  • Excellent communication and negotiation skills 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.

Maintenance Gatekeeper

  • Location: Wavre
  • Job #25474

Gatekeeper

En tant que Gatekeeper, vous assurez la qualité et la validité des demandes de travail, les planifiez ensuite en accord avec la production et les équipes de maintenance afin de réduire les temps d'arrêts planifiés et en augmentant l'efficacité de la main d'œuvre.

 
Vos responsabilités :

  • Vous collectez toutes les demandes de travail, et faites un suivi et un retour aux demandeurs ;
  • Vous évaluez la validité des demandes de travail, leur pertinence, et leur niveau de détail adapté ;
  • Vous êtes le garant du Backlog des avis, et de l’absence de doublons dans les systèmes ;
  • Vous préparez le planning court terme (1-4 semaines) avec une granularité à la pause / shift, pour tous les type d’activités ;
  • Vous animez la réunion de planification hebdomadaire avec la production ;
  • Vous planifiez les ordres de travail, y compris la préparation et le suivi de planification mensuelle et hebdomadaire ;
  • Vous conciliez le planning de maintenance avec le planning de production afin que les différentes activités soient totalement alignées.

Pourquoi vous ?
 
Qualifications requises :

  • Vous possédez un bachelier technique ou expérience équivalente ;
  • Vous possédez des connaissances des outils informatiques Excel, PowerPoint, Word, SAP ;
  • Vous possédez de minimum 5 ans d’expérience pertinente dans un environnement pharmaceutique.
  • Horaire de jour (flottant).

Qualifications souhaitées :

  • Vous êtes ouvert aux nouvelles idées, montrez un intérêt pour élargir vos connaissances, accompagnez le changement, proposez des améliorations en vue d’améliorer la performance ;
  • Vous vous organisez de façon autonome en fonction des priorités journalières, démontrez spontanément un souci d’ordre et de rigueur. Vous confirmez la planification des ordres de travail avec le client interne et la maintenance ;
  • Vous faites preuve d’esprit d’observation, vous signalez les anomalies, démontrez la compréhension du process en place.

Si vous avez besoin d’assistance ou d’aménagements particuliers, soit pour participer au processus de recrutement, soit pour vous permettre d’exercer votre travail, nous vous remercions de nous en informer de manière à ce que nous puissions prendre les mesures adéquates.

Notre Offre
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]

 

HSE Compliance Officer

  • Location: Braine-l'Alleud
  • Job #25423

HSE Compliance Officer
We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).

The person will be responsible for managing environmental issues, including the “Licence to Operate” for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.

The Responsibilities

– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities
– Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO).
– Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities.
– Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services.
– External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.

Skills and Knowledge Requirements

– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management.
– Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders).
– Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting.
– Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset.
– Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site.
– ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement.
– Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings).
– Remote work is permitted when on-site presence is not required, but there are no fixed remote work days.
Additional Assets:
– Experience with Seveso risk management (hazardous materials storage).
– GMP (Good Manufacturing Practices) certification is a plus, but not required.
– Ability to ask questions and solve problems independently.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
 

QC Equipment Specialist

  • Location: Braine-l'Alleud
  • Job #25387

QC Equipment Specialist
Join the QC team, working with a substantial analytical equipment park. The role goes beyond just qualification and maintenance of equipment, focusing primarily on the coordination of various activities related to these pieces of equipment. This role is akin to that of an architect, as it requires an overall view of the equipment's lifecycle.

The Responsibilities

  • Equipment Management:
    • In the event of a breakdown, identify and coordinate necessary actions with internal and external stakeholders.
    • Follow-up on equipment, install new equipment, and manage related projects.
    • Coordinate with support departments to ensure proper maintenance, qualification, and installation of equipment.
    • Project Management: Track timelines, budgets, and required resources for installation or upgrades of equipment.

 

  • Activity Coordination:
    • Serve as the point of contact for different stakeholders: qualification/validation, maintenance, IT, QA, laboratory (end users).
    • Perform testing, when necessary, in collaboration with the laboratory.
    • Ensure smooth execution of projects while adjusting priorities and juggling multiple tasks.

 

  • Planning and Monitoring
    • Manage several simultaneous projects, with up to 4 to 5 pieces of equipment to manage per person.
    • Use the Integrate software to track various projects and activities.

Required Skills and Profile

    • Rigorous and Organized: The candidate must be highly structured and able to manage shifting priorities.
    • Multitasking: Ability to work on multiple projects at once, sometimes dealing with urgent changes in priorities.
    • Experience with Laboratory Equipment: Knowledge of analytical equipment in GMP (Good Manufacturing Practices), such as HPLC, UPLC, UV, Infrared, PCR vessels, fridges, and freezers.
    • Familiarity with LIMS, Source, and Integrate systems is a plus.
    • Communication Skills: Ability to understand and write documentation in English (B2 level minimum), as equipment documentation is mostly in English. Ability to communicate with external suppliers and manage international interactions.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]