Validation Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #19881

Validation Engineer

Contracting – Brabant Wallon 

Your responsibilities ? 

  • Write final URS, finalize URS reviews
  • Perform risk assessments, FMEA (quality and safety) and DoE
  • Follow-up manufacturers (design, manufacturing, testing, FAT-SAT)
  • Write and/or review validation protocols (FAT, SAT, IQ-OQ and PQ)
  • Schedule and design validation activities, priorities, logistics, supplier interventions
  • Perform or manage validation and flows of documentation
  • Write standard Visual Inspection and/or Leak Detection instructions
  • Write change management documents

Your profile?

  • You have a scientific background or equivalent acquired through professional experience 
  • You have minimum 3 years experiences in validation and/or metrology
  • You have an experience in Qualification/validation process in a pharmaceutical environment (GMP)
  • You are a good communicator
  • You are autonomous, rigorous, team player with a critical mind 

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] 

Automation Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #19761

Automation Engineer

Brabant-Wallon – contracting 

#GMP #SME

Our partner is looking for an Automation Engineer to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

  • Support technically the global projects for upgrading different automation applications
    • The applications in scope are SCADA, Particles & Environment monitoring systems, Serialization & aggregation, Automatic backup & Versioning control.
  • Assess and study the install base of each application in scope of each project
  • Do the market analysis and benchmarking to identify the proper solution for each application
  • Collect system requirements involving different sites SME’s, challenge them for identifying new ways of working and seeking modernization of applications use
  • Build testing environment for the identified solution/s to properly test it
  • Work closely with the vendor of the solution to identify the proper design & architecture
  • Build the LDD (Landscape Definition Document) of the solution assuring highest redundancy and availability
  • Work with Tech (IT) to identify the proper build of the infrastructure to assure the proper management and maintenance of the application across its life cycle
  • Work with OT team to assure that OT controls and policies are properly considered in the design and development of the solution
  • Work with Data management team to assure the proper interfacing with Historian is considered
  • Participate in creating the system URS
  • Review the design specification documents (SDS, FDS, HDS, NDS, …etc.)
  • Review the related IT documents to the application (DRP, SP, …etc.)
  • Work with Automation CAPEX PMO to assure the proper planning and interdependency between different projects is well considered
  • Work with Automation CAPEX team to assure the proper execution of the projects
  • Identify and escalate any associated risk to project technical execution
  • Collaborate with sites automation teams during Project mode & BAU (Business as Usual)
  • Act as expert in his/her domain of competence

Who are you?

  • You hold a master's degree
  • You have at least 5 years of experience in a similar role in a GMP environment
  • You have good knowledge of OT Industrial automation Systems in general, in particular Wonderware Archestra, Siemens & Allen Bradley PLc’s
  • You have basic knowledge of EMS (Environment Monitoring System) & BMS (Building Management System)
  • You are fluent in English. French is a plus

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 Sophie Rolis: [email protected] or +32497/51.50.92

GMP Compliance

  • Location: Wavre
  • Type: Contracting
  • Job #19708

GMP Compliance

Brabant-Wallon – contracting 

Our partner is looking for a GMP Compliance to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

  • Ensuring potentially the release of the commercial batches in compliance with the Good Manufacturing Practices and regulatory requirements
  • Maintaining the compliance level with GMP regulations/requirements within the EM
  • Being the Quality contact point for the selected contractor / supplier you are support for 
  • Ensuring that Quality systems are in place/in use, routinely monitored and assessed
  • Ensuring accountability for all quality activities linked to the contractor / supplier management (deviations, CAPA closure, risks management, complaints, product quality review, changes handling)
  • Maintaining a good relationship with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings
  • Representing Quality EM within various governance meetings and timely escalate issues to Manager when required through established process 
  • Potentially managing Questions & Answers packages and commitments linked to Health authorities requests in due time  

Who are you?  

  • You hold a university Scientific background (Pharmacist, PhD in Life Sciences, Bio Engineer, etc.)
  • You have experience within the pharmaceutical industry on the field (QA, Manufacturing)
  • You have knowledge in sterility assurance/Secondary operations and a good understanding or experience in product release
  • You are fluent in English and in French

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

 

Automation Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #19703

Automation Engineer

Brabant-Wallon – contracting 

Our partner is looking for a Automation Engineer to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

  • Centralizing, organizing and prioritizing all the activities that need to be performed centrally and locally in order to deliver on the Program’s commitments as well as each of the individual sites’ commitments in agreement.
  • Communicating the plans, roadmaps and detailed paths to success to the rest of the program team and to sites, as needed.
  • Closely cooperating with all internal (project) and external (local sites) stakeholders to obtain the technical requirements, constraints, cost and planning information needed for you to create a central demand roadmap.
  • Planning meetings and for the communication and follow-up of the output of these meetings.

Who are you?

  • You are fluent in French and English
  • You hold an engineering degree or equivalent in Mechanical, Automation, Electrical or Chemical.
  • You hold a robust experience with automation projects
  • Background in the pharmaceutical industry is a plus

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

 

QA Admin

  • Location: Wavre
  • Type: Contracting
  • Job #19705

QA Admin

Brabant-Wallon – contracting 

#GMP #QA #Admin

Our partner is looking for a QA Admin to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

You will manage process & communication of lifecycle and change control activities for different sites and interaction with external collaborators by:

  • Developing further the process to prepare content on change controls for communication to external partners.
  • Managing meetings with external stakeholders and present information to Quality, regulatory and technical collaborators  
  • Organizing the transfer of information on change controls between the company and QA department from external partner
  • Establishing & tracking key performance indicators for each step of the process
  • Leading the design of or optimization of process
  • Following the implementation of changes and ensure alignment with RA and external partners to minimize the impact on supply continuity.
  • Writing local SOP with new process, and ensure training of all stakeholders (MPU, QA, QC, site conformance, RA,MSAT).
  • Collaborating on punctual projects such as participation to taskforces, development of standards.

Who are you?

  • You are fluent in French and English
  • You hold a scientific/engineering degree (minimum BAC+4) (chemist or biochemist)
  • You are flexible with ability to adapt to changing scope & priorities 
  • You are able to lead and manage cross-functional projects
  • You are Autonomous and results-driven

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

 

Superviseur Validation Biochimie

  • Location: Wavre
  • Type: Contracting
  • Job #19702

Superviseur Validation Biochimie

Brabant-Wallon – contracting 

#GMP #Validation #Biochimie

Notre partenaire est à la recherche d’un Superviseur Validation Biochimie pour compléter son équipe.  Cette mutli-nationale est bien connue pour ses vaccins.

Quelles sont vos responsabilités?

  • Ecrire des rapports en lien avec la validation de méthode.
  • Etablir la stratégie de validation d’une méthode analytique
  • Ecrire le protocole de validation traduisant la stratégie de validation
  • Communiquer avec les techniciens de laboratoire et faire le suivi des testings liés à la validation
  • Collecter et interpréter les données analytiques (avec investigation lors d’écart par rapport à l’attendu)
  • Ecrire le rapport de validation en collaboration avec le Validation Manager et le QA

Qui êtes-vous?

  • Vous avez un diplôme en biochimie
  • Vous avez au moins 3 ans d’expérience dans une fonction similaire en milieu GMP et au QC
  • Vous avez de bonnes connaissances en ELISA, SDS page, HPLC et êtes à l’aise avec les programmes Excel et Word
  • Vous êtes autonome, flexible et avez un fort esprit d’équipe
  • Vous avez un bon niveau d’anglais (écrit et oral)

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 Sophie Rolis : [email protected] ou +32(0)497/51.50.92

QA Complaints Specialist

  • Location: wavre
  • Type: Contracting
  • Job #19647

QA Complaints Specialist

Brabant-Wallon – contracting 

#GMP #QA

Our partner is looking for a QA Complaints Specialist to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

You will analyze, coordinate investigations of Manufacturing sites, and provide an investigation report (interim/final) for the received complaints. Here are your main activities:

  • Support the team in their day-to-day activities
  • Owning complaints and to bring support on tasks related to complaints system (ad'hoc tasks related trends analysis, L1 audit, Annual Product Review… )
  • Be the main interlocutor when some additional information is needed.
  • Challenge manufacturing site investigation and summarize the investigation to the reporters.
  • Take the ownership on complaint management improvement 

Who are you?

  • You hold a bachelor’s degree in sciences (e.g., Bio Engineer, Biologist, Chemist)
  • You have at least 3 years of experience in a GMP environment (preferably in relation with deviation or complaint handling)
  • You are customer oriented and ready to work in a global and complex organization (open minded, flexible and quality mindset)
  • You are fluent in English and French, (both spoken and written)

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 Sophie Rolis: [email protected] or +32497/51.50.92

Process Engineer

  • Location: wavre
  • Type: Contracting
  • Job #19537

Sustainability Engineer

#Pharma#Utilities#durability 

Our renowned client from the pharmaceutical industry is looking for a Process Engineer to complete their team. 

Regarding the project, here is some information: 

As Sustainability Engineer, you will support investment projects (revamping and greenfield) by bringing your expertise to propose solutions on all sustainability topics (including utilities, energy consumption, HVAC, building shell, wastewater treatment, etc.).

What are your responsibilities?

  • You are able to punctually travel abroad
  • You will conduct the analyze of projects on the energy and sustainability level in different project stages
  • You will work together with the SME to make sure the recommendations are implemented.
  • You will keep in mind the bigger picture: Total Cost of Ownership consideration.
  • Understanding of a product/process lifecycle
  • You will conduct calculations to prove the gain (financial and/or energy wise) for your recommendations and you are able to present a business case for them.
  • You ensure that the design of our facilities meets our sustainability targets, while not jeopardizing the projects’ objectives (EHS, Quality, Cost and Schedule).
  • You will use your knowledge by comparing installations on site to see the real energy consumption (energy / mass balances) and base your recommendation by what has been proven in the field.
  • You assess and monitor capabilities of partners (Engineering Offices, Contractors and Service Providers) and provide relevant support to enhance these capabilities.
  • With a mindset oriented to continuous improvement, you keep up-to-date on evolutions of technological, regulatory, maintenance and safety requirements and ways-of-working and assess potential impacts and opportunities 

Let's talk about you ! 

  • 8 year-experience in comparable domain (e.g. contractor company, service provider, engineering office, industrial company)
  • Strong technical background and broad knowledge (multiple aspects: technologies, calculations, works execution, energy)
  • Fluent in both English and French (written and spoken)
  • Knowledge or experience in Facilities and Utilities domains
  • Experience in a cGMP environment.
  • Ability to discuss and negotiate technical matters with suppliers and projects’ partners.
  • Knowledge of BREEHAM/LEEDS standards considered as a plus

What we offer you ? 

Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner every step of the way.

Are you interested in this offer? We invite you to apply. If you have any questions, please contact Marie Rossenfosse : [email protected] 

Packaging Engineer

  • Location: wavre
  • Type: Contracting
  • Job #19535

Packaging Engineer

Brabant Wallon – contracting 

#Packaging #Pharma #GMP

Notre partenaire est activement à la recherche d’un Packaging Engineer pour completer son équipe pour un projet de modernisation d’équipements de packaging de vaccins. Notre partenaire est une multinationale connue pour ses vaccins.

Quelles sont vos responsabilités?

  • Support au demandeur afin de clarifier son besoin  
  • Etude préliminaire (layout, chemin d’introduction de l’équipement, impacts sur les machines amont/aval, impact validation, …)
  • Rédaction d’un URS via UR Tool afin de faire valider le projet/l’équipement au sein de la companie et de permettre un appel d’offres vers différents fournisseurs présélectionner
  • Organisation de la phase d’appel d’offres: présélection des fournisseurs, analyse des offres, alignement techniques et rédaction d’une recommandation
  • Suivi des fournisseurs pendant les phases de préparation/préfabrication (technique et planning)
  • Si nouvel équipement: réception de l’équipement et de la documentation chez le fournisseur (FAT)
  • Analyse des besoins en termes d’alimentations électrique et pneumatique, connexion au réseau data
  • Organisation de ces connexions
  • Gestion des master data SAP
  • Participation à l’établissement des différents plannings
  • Définition et commande des équipements auxiliaires
  • Préparation de la validation (SRA; ERES; FMEA)
  • Gestion sécurité et technique du fournisseur durant la réalisation des travaux
  • Maitrise technique des modifications / du nouvel équipement via le suivi du commissioning
  • Tests de commissioning
  •  Réalisation et documentation des tests IQOQ
  • Documentation permanente des modifications réalisées via avis SAP
  • Support utilisateurs et maintenance pour mise à jour de leurs documents
  • Formation des utilisateurs et maintenance
  • Suivi punchlist
  • Handovers
  • Suivi « après-vente » afin d’assurer une rapide montée en performance de la machine (formation, amélioration technique)
  • Participation aux réunions de projets, aux tier « chantier »
  • Gestion des CAPA et déviation associées au projet

Qui êtes-vous?

  • Vous possédez un master et avez une expérience dans la gestion de projets techniques de packaging dans le secteur pharmaceutique (GMP)
  • Vous possédez l’accréditation BA5
  • Vous avez une excellente capacité de communication et esprit de synthèse
  • Vous avez une bonne connaissance de l’anglais et du français (lu et parlé)

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 Sophie Rolis : [email protected] ou +32(0)497/51.50.92

HVAC Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #19423

HVAC Engineer

Brabant Wallon – contracting 

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

What are your responsibilities?

In coordination with Engineering Office and Project Manager, ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities' requirement of HVAC packages;

Related to these packages, it includes:
 

  • Being the company representative for all HVAC-related activities and installations
  • Supporting the E.O in management of activities related to this package
  • Ensureing alignment between E.O and our partner’s Specification and Guidance
  • Reviewing design and technical documentation
  • Following-up construction & all testing activities falling under the package’scope
  • Ensure systems start-up and punchlist solving
  • Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
     

Who are you?

  • You are Industrial or Civil Engineer with 8 years of experience in a similar role within the pharmaceutical industry (GMP knowledge)
  • You hold the BA4 BT electrical certification
  • You are autonomous, good communicator and team player.
  • You are fluent in English and French

 

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