• Location: Braine L'Alleud
• Type: Contracting
• Job #20719

Project Engineering Leader

Brabant Wallon – contracting 

Our partner is looking for a Project Engineering Leader and a Construction Manager to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?
The Project Engineering Leader is accountable of the design and execution of his projects – mainly in infrastructure/building revamping or construction by:
 

• Partnering with engineering firms to ensure proper support in delivering the project designs & execution   
• Working with our Business Partner to define the best solution to meet customer needs
• Managing cost and planning for all engineering projects activities
• Managing Basic / Detailed design and execution
• Ensuring technical resources identified without gaps nor overlap
• Handling project governance, budget controlling in accordance with PMO requirements
• Overseeing the project team supervision
• Consolidating and reviewing specifications (e.g. URS, Technical Specifications)
• Ensuring strong communication with stakeholders and team project
• Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement and collaboration
• Dealing project engineering package of medium to high complexity

   

Who are you?

• You hold a Master’s degree in in Life Sciences (biochemistry, pharmaceutical sciences, …) 
• Good written and oral presentation capability in English
• You have at least 5 years of relevant experience
• You have experience experience in (complex) projects.
• You have experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models
• You have excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously

What can you expect?

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

 

 

 

 

• Location: Braine L'Alleud
• Type: Contracting
• Job #20708

Qualified Person Consultant

Contracting – Brabant Wallon 
#QA #QP #Pharma 

Notre partenaire est activement à la recherche d’un QP pour completer son équipe. Notre partenaire est une multinationale connue pour ses produits pharmaceutiques. 

Quelles sont vos responsabilités?

Le domaine de l’activité en tant que QA/QP sera de s’assurer que les opérations en relation avec les matières premières et les produits pharmaceutiques importés ou fabriqués respectent les réglementations nationales et/ou internationales ainsi que les guidances (cGMP) et les polices qualité. 
Pour ce faire, voici les tâches qui vous seront confiées : 

• Vous serez responsable de la libération et certification des lots de produits sus-mentionnés, ainsi que de la gestion des échantillons légaux
• Vous serez garant des déviations qualité, des investigations, des CAPAs, des plaintes marché/clients, des rappels, des change controls temporaires et permanents
• Vous serez en charge de la rédaction, revue et approbation des Product Quality Review   
• Vous serez responsable du suivi et support QA aux projets définis par le management QA, et plus spécifiquement en lien avec les activités de release et de production.
• Vous réaliserez des audits internes, et vous participerez aux audits clients et inspections en relation avec le champ d’activité    

Qui êtes-vous? 

• Vous avez un diplôme de pharmacien d’industrie avec obtention du numéro de personne qualifiée (QP)
• Vous disposez d’une expérience dans le milieu pharmaceutique GMP ou dans une position similaire, et/ou expérience en Assurance Qualité, Production ou Contrôle Qualité
• Vous avez une bonne connaissance des réglementations internationales en lien avec les activités GMP
• Vous êtes fluide en  français et en anglais, à l’oral et à l’écrit 

Que pouvez-vous attendre? 

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matières techniques et soft skills. Nous serons votre partenaire de carrière pour chaque étape de votre chemin. 
Cette offre vous intéresse ? Nous vous invitons à postuler. Si vous avez des questions, vous pouvez contacter Aurélie Montes Suarez: [email protected] ou +32(0)472/44.83.18

• Location: Braine l'Alleud
• Type: Contracting
• Job #20714

Quality Lead Manager

Brabant Wallon – contracting 

Our partner is looking for a Quality Lead Manager to join its team. This international company is well-known for its pharmaceuticals. 

What are your responsibilities?

This position provides support to a group of Global Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development (intermediate to Finished Product), including submissions, launches, product improvements and phase out by:
 

• Preparing Product Change Control Committe and change controls follow-up  
• Managing Maintenance and lifecycle of QA product flows     
• Managing audits and inspections
• Reviewing Annual Stability Plan  
• Writing SOPs and other control documents
• Managing risk management and mitigation
• Reviewing CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products
• Preparing and executing product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation)     

Who are you? 

• You hold a Bachelor’s/Master degree in Life Sciences (biochemistry, pharmaceutical sciences, …) 
• You have at least 3 years experience in the pharmaceutical/biologics industry in a quality management position
• Good written and oral presentation capability in English
• You are able to work autonomously
• You are able to deliver presentations or reports adapted to the audience
• You can independently analyze data and information to draw conclusions and make effective decisions

What can you expect?

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18 

• Location: Braine l'Alleud
• Type: Contracting
• Job #20715

Project Engineering Leader

Brabant Wallon – contracting 

Our partner is looking for a Project Engineering Leader to join its team. This international company is well-known for its pharmaceuticals. 

What are your responsibilities?

The Project Engineering Leader is accountable of the design and execution of his projects – mainly in Biologics and Injectables process and clean rooms by:

• Partnering with engineering firms to ensure proper support in delivering the project designs & execution
• Working with our Business Partner to define the best solution to meet customer needs
• Managing cost and planning for all engineering projects activities
• Managing Basic / Detailed design and execution
• Ensuring technical resources identified without gaps nor overlap
• Managing project governance, budget controlling in accordance with PMO requirements
• Overseeing the project team supervision
• Consolidating and reviewing specifications (e.g. URS, Technical Specifications)
• Ensuring strong communication with stakeholders
• Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement and collaboration
• Managing project engineering package of medium to high complexity

Who are you?

• You hold a master’s degree
• You have at least 5 years experience of engineering experience in investment projects in the Biologics or Injectables field
• Good written and oral presentation capability in English
• You are able to share good practices and knowledge
• You have strong technical, interpersonal and leadership skills
• You can translate customers’ needs in technical requirements

What can you expect?

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

 

 

• Location: Braine l'Alleud
• Type: Contracting
• Job #20698

Product Planner

Brabant Wallon – contracting 

Our partner is looking for a Product Planner to join its team. This international company is well-known for its pharmaceuticals and vaccines.
 

What are your responsibilities?

You will ensure products availability on markets and you will optimise the supply chain costs through assets capacity optimization and inventory management.
Here are your main tasks:
 

• Build and to execute SIOP & ISSP Supply Plans and Scenarios in the tactical and strategic horizons for commercial and Ph3 development products with the support of ANAPLAN system
• Integrate market and external customer tactical & strategic demand to build optimized capacity constrained plans for the whole supply chain stream of her/his product family ensuring E2E visibility and accountability 
• Support supply decisions with CMO and the company plants to balance customers service level, OTIF & costs within the supply tactical and strategic horizon through the appropriate decision-making process;
• Facilitate the translation of Product tactical & strategic plans into CMO and the company Sites Master Production schedules with a good collaboration with Planning operational teams
• Represent the Global Planning team within Key Projects related to his/her products portfolio, including new products launches
• Support the SI&OP and ISSP supply planning for the E2E product value stream to align the company installed capacity to the global products demand, optimize inventory and asset usage for the company
• Issue monthly feasible production plans to internal and external manufacturing partners by running RRP and RCCP supply processes
• Manage the supply risk on tactical & strategic horizons in collaboration with markets, PVU SL, Finance, Vendors, QA and Planning operational teams
• Help prepare yearly product budgets (from a volume standpoint) and long-range plans
• Coordinate supply process and system set-up to support and accelerate next company product launches from a master planning standpoint (capacity, best tactic, risk management)
• Be an ambassador of the company and Global Supply chain values in action

 

Who are you?

• You hold a bachelor’s degree
• You have 5 years minimum of experience in Supply Chain with past proven experience in Master Planning activities
• You have experience in SAP & ANAPLAN or demonstrated capability to adopt UCB systems in place
• You have an analytical mindset, you are KPI and Result Driven
• You have a Background in Pharma Operations
• You are fluent in French and in English

What can you expect?

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

 

 

 

 

 

 

 

 

 

 

• Location: Braine l'Alleud
• Type: Contracting
• Job #19854

Technicien QC – IPC

#Contracting #Brabant Wallon #Shift

Pour son laboratoire de contrôle qualité, notre partenaire est à la recherche d’un technicien analyste dont la fonction consiste à la réalisation et l’évaluation des analyses des échantillons issus de la production et d’autres départements.

Votre mission?

• Mettre en œuvre et interpréter les analyses d’échantillons devant être pris en charge par le laboratoire ainsi que les documents associés (RE, CAPA, OOS, NCP, …)
• Participer au transfert et à la validation de méthodes analytiques.
• Participer aux interventions, aux maintenances planifiées et qualifications des appareils analytiques.
• Participer à la maintenance du laboratoire.
• Rapporter les déviations des processus analytiques, les problèmes techniques et exécuter les actions correctives.
• Participer à la formation des nouveaux analystes.

Votre profil?

• Vous avez un bachelier en Chimie
• Vous avez une expérience relevante en HPLC et en laboratoire QC en industrie pharmaceutique (GMP)
• Vous avez une expérience en validation de méthodes analytiques HPLC (GC); utilisation du KF (Karl Fischer) et de la GC
• Vous avez une grande rigueur, une bonne organisation, et un excellent esprit d’équipe

Ce que nous vous offrons ?

Un CDI avec un package salariale correspondant à votre expérience et compétences. L'opportunité de développer vos compétences au sein d'un grand groupe pharmaceutique de renommée international.

Ce poste vous intéresse? Si vous avez des questions n'hésitez pas à contacter Sophie Rolis [email protected]

• Location: Braine l'Alleud
• Type: Contracting
• Job #19196

Change Leader

Contracting – Walloon Brabant

#laboratory #productrelease #procedures #changes #requirements

Our partner is currently looking for a Change Leader to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

As a Change Leader, you will be in charge of the management of local specification to allow laboratory testing and Product Release, and you will ensure local specification are compliant to market and regulatory requirements. To be successful in your role, here are your tasks:

Operational:

• Manage local specifications changes (create / update) according to procedures in place and business needs.
• Coordinate the creation/review of the specification ensuring that the content is defined and developed with the involvement of the appropriate experts / stakeholders to grant compliance to regulations and related file.
• Checks the progress of the change with stakeholders and escalates any risks in the initially planned implementation schedule.
• Ensure communication between subject matter experts and stakeholders. Ensure all information is provided to the specification author to write local specification document in ECMS.
• Informs Lims partner when the specification is in status issued in ECMS and ensures to provide on time specific information allowing Lims configuration /process to operate with efficiency.
• Ensure planning and coordination in order to satisfy the client needs. Organize or participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.
• Ensure local specification implementation is in alignment with global specification status.

 

Quality:

• Implement, follow-up and communicate on KPI.
• Ensure the continuous improvement of the activity.
• Ensure update or creation of related procedures and instructions.
• Ensure follow-up of corrective actions and preventive actions. Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits.
• Ensure the follow-up of deviations and appropriate root cause analysis to address the right action plan.

HSE:

• Apply the company's Health and Safety policy
• Ensure a safe working environment to meet site safety objectives

Who are you?

You hold a master’s degree in a scientific domain. You have a proven experience in a GMP/laboratory environment. You have also an experience in data management (LIMS, SAP). You speak fluently French and English.

What can you expect?

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 Marie Rossenfosse, [email protected]

• Location: Braine L'alleud
• Type: Contracting
• Job #19132

Technicien(-ne) LIMS

Brabant Wallon – Contracting 
 

Notre partenaire est activement à la recherche d’un Technicien (-ne) LIMS pour completer son équipe. Notre partenaire est une multinationale connue pour la fabrication de produits pharmaceutiques.

Quelles sont vos responsabilités?

Au sein de l’équipe QC System du Département QC, le Technicien LIMS assure l’implémentation du système LIMS et tout ce qui s’y rapporte, dans le respect des règles cGMP’s, de la sécurité et des procédures en place.

Tâches principales

• Créer, modifier des spécifications dans le LIMS (y compris sampling plan, item code, …)
• Créer, modifier des analyses dans le LIMS
• Gérer l’aspect documentaire associé aux implémentations LIMS (Change request notamment)
• Participer et tester l’implémentation des fonctionnalités et rapports
• Participer à la gestion documentaire associée (déviation, CAPA, Change request).
• Apporter le support nécessaire à l’équipe en place
• Rapporter les déviations liées au LIMS (en utilisant le software de gestion des déviations en place), les problèmes techniques et exécuter les actions correctives 
• Proposer à son responsable toute mesure identifiée comme pouvant améliorer le travail dans le département du point de vue qualité, efficacité, sécurité, … comme exactitude et précision des méthodes, modifications de procédures, …
• Participer à l’identification des éventuels manquements du LIMS en matière de « Data Integrity » et proposer des solutions
• Participer à la formation des nouveaux membres du département et gérer les demandes d’accès.
• Participer à l’analyse et la mise en place de nouvelles fonctionnalités dans le cadre du LIMS 
• Interagir avec les équipes LIMS des autres sites et équipe globale.
• Participer à la résolution des problèmes liés au LIMS avec les équipes LIMS et les équipes sur le terrain.

Quel est votre profil ?

• Vous disposez d’un master en sciences, Bioingénieur ou assimilé (à titre d’information) (à titre d’information)
• Vous avez une bonne compréhension des flux (échantillons, données, résultats, certificats, …) en milieu QC
• Vous êyes dôté d’un esprit logique, synthétique, tout en aillant la capacité de vue d’ensemble
• Vous faites prevue de rigueur : suivi des règles GMP dans le respect des procédures et des méthodes analytiques.
• Vous pouvez gérer de la documentation GMP et suivi du data integrity
• Vous faites prevue de flexibilité et esprit critique
• Vous êtes organisé(e)
• Vous êtes autonome et proactive
• Vous parlez et écrivez correctement en anglais

Que pouvez-vous attendre?

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matières techniques et soft skills. Nous serons votre partenaire de carrière pour chaque étape de votre chemin.

Cette offre vous intéresse ? Nous vous invitons à postuler. Si vous avez des questions, vous pouvez contacter Aurélie Montes Suarez : [email protected] ou +32(0)472/44.83.18

 

• Location: Braine-l'Alleud
• Type: Contracting
• Job #18296

Energy & Utilities Early Design Engineer

Contracting – Brabant Wallon 

Our partner is looking for a Energy & Utilities Early Design Engineer to reinforce its teams. Our partner is a well-known pharmaceutical industry.

Your responsibilities?

The Energy & Utilities Early Design Engineer is responsible for carrying out feasibility studies of Energy and utilities projects within Sites & Infrastructure Investment Strategy & Early Design Department and more particularly for the energy and utilities projects:

1. Consolidates the ideation of the energy and utilities projects: ​

   -​​Prepares and present scenarios to management for strategic decisions.
   -Delivers Feasibility and Early Design: user requirement brief, technical deliverables, budget, schedule, risks, alternative, prioritization
   -Transfers the feasibilities to the Delivery department in compliance with the governance
    

2. Assists the Sites & Infrastructure Partner, mainly in the field of energy and utilities:
   – Collecting user and site requirements
   – Completing the Project Ranking Forms
   – Establishing the project portfolio in the form of an investment plan
   – Contributes to the implementation of the Sites Master Plan
    
3. Propose technical solutions in order to:
   – 2030 environmental objectives: carbon neutral &reducing our water consumption by 20%.
   – Guarantee the necessary energy supplies
   – Optimize the Sites Utilities equipment’s and networks
    
4. Connect with his peers to have a deep understanding of the different Masterplans (Networks, Manufacturing, Laboratories…)

Your profile ? 

• Minimum 10 years in Infrastructure and Utilities projects like Project Leader or equivalent
• Minimum 2 years within chemical, pharmaceutical or biotech company with technical background (Energy, Utilities)
• Experience in capital and asset management
• Experience in Masterplan building
• Fluent in French and English.
• Expertise in cGMP, Green and HSE standards
• Expertise in chemical and pharmaceutical standards
• Good financial background, especially in depreciation management.
• Fundamentals in people management (incl change, decisions, conflicts, coaching, leading, etc…)
• Background and experience with risk management.
• Very good communication skill
• Good analytical impact on the business/legal rules.

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.