• Location: Wavre
• Job #25863

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 5 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 layouts
• 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,…),..
• Team working & Communication, Autonomy, Contractors' management.
• Good project integration experience: organisation, schedule, qualification, validation, technologies.

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] 

• Location: Wavre
• Job #25849

GMP Compliance

Contracting – Brabant Wallon

Your responsibilities:
Support the Quality SPOC for selected contractors / suppliers (in transfer or in commercial operations) for:

• Ensuring that Quality systems are in place/in use, routinely monitored and assessed
• Mastering quality agreement content
• Releasing validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
• Ensuring all quality activities linked to the contractor / supplier management (deviations, CAPA closure, change control, risks management, complaints, product quality review, …)
• Ensuring and maintain good relationships with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings.
• Representing the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
• Identifying risks associated to the specific activities of the CMO
• Driving continuous improvement projects with CMO and with internal and external stakeholders (Operations, Technical group, etc.) in order to strengthen the manufacturing activities

Your profile:

• University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
• Min. 5 years of experience in Pharmaceutical Industry associate with a GMP background
• Experience as in QA or production department, with expertise on the field, in quality systems or release. SAP experience is mandatory (deviation, CC, CAPA, …).
• Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
• Fluent in English and French
• Excellent communication (including presentation) and influencing skills.
• Stakeholders’ management: ability to interact with internal & external stakeholders
• Ability to travel to CMO (less than 1x/2month)

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]
 

• Location: Wavre
• Job #25715

Process Engineer

Walloon Brabant – contracting

Our partner is seeking a highly motivated and experienced Consultant to lead an innovative automation project in the Global Quality Control (QC) area, specifically focusing on microbiology. The ideal candidate will have a strong background in automation, excellent communication skills, and the ability to write comprehensive user requirements. They will be responsible for exploring both external supplier solutions and internal potential solutions to enhance our QC processes. Additionally, they will need to prepare business cases with the help of different sites to support the project.             

Your responsibilities?

1. Project Leadership:

• Lead the automation project in the QC microbiology area from inception to completion.
• Develop and maintain project plans and timelines
• Coordinate with cross-functional teams to ensure project objectives are met.

2.Technical Expertise:

• Utilize technical knowledge in automation to identify opportunities for innovative process improvements in microbiology.
• Assess current QC microbiology processes and recommend automation solutions.
• Stay updated on the latest advancements in automation technologies and their applications in microbiology.
• Write clear and detailed use requirements for automation solutions.
• Collaborate with stakeholders to gather and document functional and technical requirements.
• Ensure that user requirements align with business objectives and regulatory standards.
• Research and evaluate external supplier solutions for QC microbiology automation.
• Conduct feasibility studies and cost-benefit analyses of potential solutions.
• Explore and assess internal solutions and resources for automation implementation.
• Prepare a comprehensive business case for the automation project with the assistance of different sites.
• Collaborate with site representatives to gather data and insights to support the business case.
• Present the business case to senior management and stakeholders to secure project approval.
   
• Emphasize the innovative aspects of the project, exploring cutting-edge technologies and methodologies.
• Identify and implement novel automation solutions that drive efficiency and effectiveness.
   

Your profile?

 

• Bachelor’s degree in engineering, Automation, Microbiology, Computer Science, or a related field.
• Proven experience in leading automation projects, preferably in a QC or pharmaceutical environment.
• Strong technical knowledge of automation technologies and their applications (preferably in microbiology).
• Excellent communication and interpersonal skills.
• Ability to write comprehensive and detailed user requirements.
• Experience in evaluating and selecting external supplier solutions.
• Strong problem-solving skills and the ability to think critically.
• Ability to work independently and manage multiple tasks simultaneously.
• Experience in the pharmaceutical or healthcare industry is a big advantage
• Knowledge of regulatory requirements related to QC microbiology processes.
• Familiarity with project management tools and methodologies.
• Fluent in French / 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. 
 

• Location: Wavre
• Job #25688

QA Validation Specialist
Brabant Wallon – Consultance  

Are you interested in the pharmaceutical industry and putting your knowledge of validation to good use?
Our client is actively looking for a QA Validation Specialist to strengthen its activities.

What are your responsibilities?
As QA Validation Specialist, you are in charge to :

• Responsible for the coordination of the validation of small projects Primary industrialization or Secondary (Formulation or Filling) or QC streams related to equipment such as freeze dryer, autoclaves, oven…or CIP, SIP,Mediabulk, Mediafill, Mediaform or utilities or process control/automation equipment.
• Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
• Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects
• Responsible for VMP (Validation Master Plan)
• Review and approve protocols and certificates for IQ/OQ/PQ and check-lists
• Write QSR (Qualification status report)
• Manage deviations and out of specifications: bring expertise and help in investigating and solving issues
• Ensure correct and state of the art Validation approaches for RPC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…)
• Participate as expert in external authorities inspections
• Responsible for assuring inspection readiness – regarding Validation – by Corporate functions and RA authorities
• Bring expertise and coaching to streams
• Project Management: control/monitor cost and planning. Take corrective actions if necessary.
• Ensure coordination with all key players (local QA, Global QA, C&M, Streams rep,…)

Who are you?

• You are graduated as a Pharmacist’s degree or a Master Science.
• Expertise in validation, knowledge of International standards (CFR and Eudralex), GMP and Regulatory
• Successful experience in people management 
• At least 5 years experience in aseptic processing or vaccine production
• You fluently speak French and English.

What can you expect?
A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.
You’re interested in this job? We kindly invite you to apply ! 

• Location: Wavre
• Job #25596

EHS Support
Brabant Wallon – Contracting
#Pharma #GMP #EHS #Production
Vos responsabilités ?

• Réalisation des Analyses de risques Fire et des dossiers d’intervention fire pour les différents bâtiments manufacturing
• Sur base des ADR’s, proposer des actions de mitigations
• Exécuter les actions de mitigations (quick wins)
• Réaliser des Analyse de risques au poste de travail des zones techniques

Votre profil ?

• Diplôme d’orientation technique et/ou EHS de type bachelier et/ou supérieur.
• Une expérience dans un job similaire est requise.
• Une expérience similaire dans le secteur pharmaceutique et connaissances des normes GMP
• Vous avez de bonnes connaissances en analyses de risques, analyses d’accident, permis de travail, …
• Vous parlez couramment français et vous avez un niveau intermédiaire en anglais.

Que pouvez-vous attendre ?
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 !

• Location: Wavre
• Job #25574

Supply Planner
Contracting – Brabant Wallon 
What are your responsibilities?
Process Order and Purchase Order Management:

• Create and manage Process Orders and Purchase Orders.
• Oversee dispatching within the EMDP logistics team.
• Monitor releases, track actions, and set up release plans in collaboration with QA.

Logistics & Scheduling Operations:

• Identify, address, and escalate issues that may impact business operations.
• Ensure timely and efficient logistics coordination.

SAP Expertise:

• Master the use of SAP within the EMDP business process (R/3, APO).
• Support testing in SBT/SBV environments.

Master Data Management:

• Support for accuracy and quality of all EMDP Master Data related to production, maintenance, and planning.

Who are you?

• Bachelor’s degree in supply chain management, Logistics, Business Administration, or a related field.
• Strong proficiency in SAP (R/3, APO) and related business processes.
• Excellent analytical and problem-solving skills.
• Ability to lead meetings and collaborate effectively with stakeholders.
• Detail-oriented with a focus on accuracy and quality.
• Strong communication and organizational 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.

• Location: Wavre
• Job #25559

QA GMP Compliance

Brabant Walloon – Contracting  

What are your responsibilities?

• Manage the qualification of incoming materials and suppliers (compliance requirement and validation aspects) 
• Manage change received from the supplier
• Manage a collaboration with the suppliers in order to ensure quality of suppliers, service providers and Incoming materials and to ensure that internal quality requirements and expectations are taken into consideration.
• Understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials (e.g. compliance qualification quality agreement,…)
• Manage deviation and CAPA  
• Perform and follow material qualifications in partnership with the project team
• Communicate suppliers/quality issues to stakeholders through appropriated escalation processes.
• Understand and manage actions of mitigation if needed.
• Understand and manage current regulatory requirements, as well as internal, environment related to incoming materials.
• Support team members on specific activities.

Who are you?

• Education in a relevant scientific, quality or technical discipline.
• Be able to understand main regulatory constraints and main vaccines manufacturing processes.
• Knowledge of regulatory and quality system requirements and ability for the supplier to comply with standards.
• Good verbal and written communications skills in French and English to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place.
• Ability to function efficiently in a matrix organization in order to ensure effective communication of issues to all impacted sites /functions.
• Understand negotiations related to implementation of appropriate
• Regulatory requirements and quality standards.
• Experience with Microsoft Office applications and have the ability to learn new software applications such as SAP.
• Understanding of technologies used within the material supply base.
• Understanding of cGMP regulatory requirements and standards

What can you expect?
We offer you an open-ended contract as well as an attractive salary package. You will also take advantage of the opportunity to develop yourself personally and professionally through internal training.
Interested? Do not wait any longer!
Apply directly via our website WWW.JEFFERSONWELLS.BE or send your CV to the following email address [email protected]
 

• 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]