QA CSV

  • Location: Wavre
  • Type: Contracting
  • Job #15286

QA CSV

Contracting – Walloon Brabant

#csv #computersystemsvalidation #validation #IT #QA #gmp #pharma

Are you a dynamic person? You have experience in computer systems validation in the pharmaceutical industry? Keep reading your future job description. 

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

What are your responsibilities?

As a CSV Expert, you ensure computerized systems are validated and that all external and internal validation requirements are met. To be successful in your role, here are your tasks:

  • Writing, reviewing and approving of validation plans and validation summary reports
  • Reviewing and approving of Technical Change Description
  • Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
  • Reviewing of CVS specific SOP’S and Templates
  • Ensure the proper execution of the qualification and validation activities with respect of the validation methodology

Who are you?

You have a university degree in a scientific domain. You have a strong knowledge in IT quality assurance and computer compliance demonstrated through management of projects in this area. You have a good knowledge of SAP and/or MES. You have a significant experience in CSV. You have a goog knowledge of GMP, CFR, Eudralex, … You speak fluently French and English. You are solutions and achievment oriented. You are a good team player.

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 Defruit, [email protected]

CSV Expert

  • Location: Wavre
  • Type: Contracting
  • Job #15284

CSV Expert

Contracting – Walloon Brabant

#csv #computersystemsvalidation #validation #IT #QA #gmp #pharma

Are you a dynamic person? You have experience in computer systems validation in the pharmaceutical industry? Keep reading your future job description. 

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

What are your responsibilities?

As a CSV Expert, you ensure computerized systems are validated and that all external and internal validation requirements are met. To be successful in your role, here are your tasks:

  • Act as QA authority in the assigned area of responsibility (specifically Manufacturing Execution System MES)
  • Drive adherence to computer quality & compliance policies and guidelines
  • Review and improve Computerized System Validation (CSV) documents and ensure adherence to internal and external guidelines
  • Be involved in the creation and approval of major documents like validation plans and reports
  • Ensure QA requirements for IT systems are covered.
  • Share expertise and knowledge to provide input to project teams and global functions
  • Support, communicate and follow-up on key Quality issues related to Computer Compliance.
  • Participate as subject matter expert for Compliance in Team meetings where necessary to ensure adequate representation of Computer Compliance issues for discussion and escalation.

Who are you?

You have a university degree in a scientific domain. You have a strong knowledge in IT quality assurance and computer compliance demonstrated through management of projects in this area. You have a good knowledge of SAP and/or MES. You have a significant experience in CSV. You have a goog knowledge of GMP, CFR, Eudralex, … You speak fluently French and English. You are solutions and achievment oriented. You are a good team player.

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 Defruit, [email protected]

QA Validation

  • Location: Wavre
  • Type: Contracting
  • Job #15283

QA Validation

Contracting – Walloon Brabant

#QA #validation #documentation #procedures #gmp #pharma

Are you a dynamic person? You have experience in validation in the pharmaceutical industry? Keep reading your future job description. 

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

What are your responsibilities?

As a QA Validation, you provide a compliance expertise in validation. To be successful in your role, here are your tasks:

  • Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
  • Review/Approve the validation documentation regarding the GMP requirements and the procedures
  • Ensure that production practice are aligned with validation conclusion
  • Attend all project meetings as QA validation representative
  • Ensure timely escalation to Management of critical issues during validation
  • Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
  • Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
  • To define the validation strategies through the change control process
  • To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
  • To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
  • To support the production, QA and technical service teams in the implementation of the validation activities.

Who are you?

You have a university degree in a scientific domain. You have a relevant industrial experience in validation and quality assurance in a biopharmaceutical industry. You have a goog knowledge of GMP, CFR, Eudralex, … You have a good knowledge of different regulations and standards related to validation activities. You speak fluently French and English. You are solutions and achievment oriented. You are a good team player.

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 Defruit, [email protected]

QA GMP Compliance

  • Location: Wavre
  • Type: Contracting
  • Job #15263

QA RTC 

Brabant Wallon – Contracting

#Pharma #GMP #Qualité #Assurance #Release #Trending #Compliance 

Notre partenaire, une entreprise internationale connue pour le développement et la production de vaccins, recherche un Quality Assurance Compliance pour renforcer ses équipes.

Vos responsabilités ?

  • Participer activement à la préparation des réunions de gouvernances prises en charge par le QA RTC (Release, Trending, Compliance) pour l'unité de production 
  • Supporter la préparation et la coordination aux audits et inspections
  • Participer activement à la préparation de rapports de tendances
  • Réaliser des QA Oversight et des audits internes (self-inspection) des activités sous la responsabilité du RTC
  • Mettre à jour les indicateurs de performance de l’équipe RTC
  • Participer activement à l’archivage des documents RTC 
  • Supporter le QA RTC dans les activités de release, revue Batch Record, revue QA de déviations et d'investigations plaintes

Votre profil ?

  • Formation Ingénieur ou Scientifique (biochime, biologie, chimie, pharmacien d’industrie…)
  • Minimum 2 ans d’expérience dans un environnement aseptique/laboratoire, industrie, qualité, production
  • Expérience dans un environnement règlementé tel que cGMP
  • Connaissance dans la libération de lots de vaccins
  • Une connaissance des process viraux atténués est un plus

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 !

Postulez directement via notre site WWW.JEFFERSONWELLS.BE ou envoyez votre CV à l'adresse mail suivante [email protected]

Ingénieur Méthode

  • Location: Wavre
  • Type: Contracting
  • Job #15250

Methods Engineer

Walloon Brabant – Contracting

#Pharmaceutical #GMP #Engineering 

Our partner is looking for a Methods Engineer. You will analyze the performance (Safety, reliability, availability and maintenance costs) of the Packaging manufacturing unit. You’ll work with the execution team and the engineers of several disciplines

What are your responsibilities?

  • You define and implement the visual management on packaging lines
  • You support the implementation of the quick wins related to the new maintenance strategy
  • You give support to the technical team (recurrent technical issue, root cause analysis) and to the team in charge of technical improvements on the shop floor
  • You identify, prioritize and mitigate the reliability threats
  • You follow the project from the definition to the implementation
  • You provide regular communications and status reports to your hierarchy

Who are you?

  • Master degree or equivalent by experience
  • At least 3 Years 'experience in an Industrial Method or Reliability Engineering
  •  You have a strong experience in industrial Visual Management 
  • You have experience with LEAN manufacturing tools 
  • You are fluent both in French and English
  • Proactive
  • Result oriented

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]

Automation Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #15243

Automation Engineer (H/F/X)

Région Wallonne – CDI

#Automation #Engineer #maintenance #panne #solution

Vous êtes à la recherche d'une fonction d’ingénieur en automation ? Vous êtes une personne curieuse et volontaire ? Notre partenaire est une société à portée mondiale active dans l’énergie.

Objectif : l’Automation Engineer orienté maintenance a comme mission de diagnostiquer des pannes, proposer des solutions et en analyser l’impact, faire le suivi documentaire et administratif, réaliser les modifications et les développements softwares spécifiques et généraux. Ceci afin de résoudre des pannes ou d’optimiser le fonctionnement des systèmes automatisés.

En outre, il devra être à même de réaliser des petits projets de conception, programmation et mise en service de systèmes automatisés en parallèle de sa mission de maintenance.

Quelles sont vos responsabilités ?

  1. En collaboration avec le client, le responsable de projet, et le responsable d’équipe, diagnostiquer les pannes, analyser les solutions, développer, coordonner, et mettre en service les solutions proposées conformément aux spécifications contractuelles du projet, dans le respect des délais, des budgets, des règles et des normes de qualité imposées.
  2. Il assure un suivi de ses activités sur le système de ticketing, prise en charge des demandes venant du client, suivi d’avancement et description des actions prises.
  3. Il est très rigoureux et précis : il suit, vérifie et valide ses propres documents et ses propres développements software avant diffusion.
  4. Il participe aux réunions de priorisation avec le client et le responsable d’équipe pour pouvoir proposer un planning d’exécution.
  5. Il participe activement aux rôles de garde / assistance client des projets.
  6. Il approfondit en permanence son expertise technique. Il recherche et rassemble des données concernant les nouveaux produits en termes de fonctionnement, afin de permettre aux projects managers et aux clients de faire des choix judicieux. Il se maintient en permanence en « veille technologique ». Il suit voire il anticipe l’évolution des systèmes.
  7. Il est capable d’apprendre le fonctionnement et la configuration de nouveau produits et d’en maîtriser toutes ses spécificités en autoformation ou en formation interne/externe.

Qui êtes-vous ?

  • Vous avez une formation technique en automation, un bachelier en automatisation industrielle, un master d'ingénieur électricien/électromécanicien ou automaticien ou toute autre formation équivalente.
  • Vous disposez d’une première expérience probante en automation
  • Vous parlez couramment le français et avez un bon niveau d’anglais
  • Vous disposez de bonnes capacités d’analyse et de résolution de problèmes techniques
  • Vous avez une connaissance d’au minimum un des systèmes de programmation de la liste suivante :
    1. Systèmes PLC Siemens S7, Tia Portal, PCS7
    2. Systèmes PLC Siemens WinCC
    3. Systèmes Schneider
    4. Systèmes PLC Rockwell
    5. Système DCS DeltaV Emerson
    6. Instrumentation (capteurs, mode de transmission des signaux de mesure)
    7. Actionneurs (moteurs AC, DC, vannes, électrovannes, vérins…
    8. Réseau Ethernet, Profibus, Profinet, architecture, configuration, tests et validation.
    9. Système de variation de vitesse DC et AC (ABB et/ou Siemens)
    10. Système de régulation PID, topologies de régulation.
    11. Programmation Grafcet.
    12. Base de données SQL

Que pouvez-vous attendre ?

Dans cette fonction, notre partenaire entend :

  • Vous donner l’opportunité de vous développer au sein d'une société faisant partie d'un groupe international.

  • Vous démontrer que la culture de son entreprise se caractérise par une atmosphère informelle et conviviale.
  • Vous offrir un package salarial en plus d’un salaire compétitif
  • Vous fournir une formation car la croissance et l’évolution des talents sont des éléments importants pour notre partenaire.

Vous vous reconnaissez dans cette description ? Nous vous invitons à postuler avant le 31 juillet.

Process Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #15239

Process Engineer

Walloon Brabant – contracting

#Pharma #Qualification #Process #Production

Our partner is looking for a Process Engineer who will ensure correct installation, commissioning, and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipment’s and/or Isolator technologies package in coordination with Project Management.

What are your responsibilities? 

  • Being a representative for all Secondary equipment’s and/or Isolator technologies-related activities and installations
  • Supporting the PM and users in management of activities related to this package
  • Ensure regular technical contact with MPU representative (User, QA, Validation, Maintenance)
  • Ensuring alignment to internal 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
  • 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

Who are you?

  • Engineering degree with 4 years’ experience as Process Engineer in Secondary Equipment’s and/or Isolator Technologies domains
  • Experience in the Pharmaceutical industry and cGMP environment
  • Knowledge in implementation and qualification of engineering projects
  • Experience and ability to work with a cross-functional team
  • Fluent in 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 Anaïs Malikian, [email protected]

QA Technical Services

  • Location: Wavre
  • Type: Contracting
  • Job #15032

QA Technical Services

Contracting – Walloon Brabant

#qa #gmp #qualityassurance #technicalservices #sop #deviation #capa

Do you have experience in QA in the pharmaceutical industry? Are you a rigorous? Keep reading your future job description. 

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

What are your responsibilities?

As a QA Technical Services, you will provide support and/or oversight for QA activities related to the “in place/in use” aspect of one or more Quality systems (e.g. deviation treatment) within a Manufacturing Performance Unit. To be successful in your role, here are your tasks:

  • Ensure support is provided to develop process documents that are in alignment with regulatory expectations and internal global policies and standards
  • Ensure state-of-the-art and best industry practices are reflected in our development
  • Manage QA activities related to one or more Quality Systems
  • Support the development of transversal GxP Process:

– SOPs on SOPs

– Training Management

– Archive Management

– Documentation Management

– Changement Management

– Deviation/CAPA Management

– Management review

  • Manage relationship with operations
  • Identify potential quality and compliance risks and help to manage these risks through the existing quality systems

Who are you?

You have experience in QA in the pharmaceutical industry. You are rigorous and dynamic. 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 Defruit, [email protected]

Engineer Project Coordinator

  • Location: Wavre
  • Type: Contracting
  • Job #15003

Engineer Project Coordinator

Walloon Brabant – contracting 

#Pharma #Equipment #Coordinator #GMP

You have a previous experience with equipment in pharma industry?

You are problem solving and project management oriented?

Our partner is looking for an Engineer Project Coordinator for Secondary activities GMP's facilities dedicated for Clinical trials. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?  

As Engineer Project Coordinator, you will be in charge of the coordination of new loose equipment:

– Write and check URS

– Select suppliers

– Ordering equipment

– Reception and qualification of new equipment

– Support the project (EHS risk, risk assessment process)

– Based on the evolution of the project, the mission could evolve depending on the demand

Who are you?  

You have an Engineer degree or a GMP certificate. You have a previous experience in Project Coordination and cost control. You have already managed stakeholders. You are autonomous, team spirit and stress resistant. You have good oral and written communication skills 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. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions?

You can contact Marie Defruit: [email protected]

Maintenance Reliability Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #14898

Maintenance Reliability Engineer

Walloon Brabant – Contracting

#Pharma #GMP #Maintenance #Reliability#Engineering

Our partner is looking for a Maintenance Reliability Engineer. You will analyze the performance (Safety, reliability, availability and maintenance costs) of the Packaging manufacturing unit. You’ll work with the execution team and the engineers of several disciplines

What are your responsibilities?

  • You define and implement the visual management on packaging lines
  • You support the implementation of the quick wins related to the new maintenance strategy
  • You give support to the technical team (recurrent technical issue, root cause analysis) and to the team in charge of technical improvements on the shop floor
  • You identify, prioritize and mitigate the reliability threats
  • You follow the project from the definition to the implementation
  • You provide regular communications and status reports to your hierarchy

Who are you?

  • Master degree or equivalent by experience
  • At least 5 Years’experience in an Industrial Method or Reliability Engineering
  •  You have a strong experience in industrial Visual Management;
  • You have experience with LEAN manufacturing tools like Green or Black Belt certifications
  • You are fluent both in French and English
  • Proactive
  • Result oriented

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]