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

Quality Assurance VQS

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #19748

Vendor Quality Support

Brabant Wallon – contracting

Our partner is looking for a Vendor Quality Support to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines

What are your responsibilities?

  • Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL).
  • Perform review of CMO PQR within agreed timeframe, complete PQR Assessment
  • Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates.
  • Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly.
  • In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL.
  • Review Master Batch records changes linked to change controls or to support initiation.
  • Investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow and perform assessment.
  • If needed work with the Vendor Quality Lead, the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations.
  • Support Audits preparation at our partner or at the vendors
  • Support Risk based evaluation of the vendors in collaboration with VQLs.
  • Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the assigned products and activities at the vendors.
  • Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors. Ensure regular update of relevant guidance.
  • Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL.

Who are you?

  • You hold a bachelor’s degree (or master’s degree) in a Scientific orientation
  • You have 5 to 10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
  • Hands-on field experience in failure investigations, root cause analysis, deviation review
  • Solid knowledge about European Good Manufacturing Practices (Eudralex Vol. 4)
  • You are fluent 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 Sophie Rolis : [email protected]

QC Analyst

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #19745

QC Analyst

Brabant Wallon – contracting

Our partner is looking for a QC Analyst to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines

What are your responsibilities?

This team’s primary responsibility is to perform release and stability testing according to the required GMP and regulatory standards of our client from early clinical phases to phase III. Here are your responsibilities:

  • Perform daily laboratory activities related to release and stability testing
  • Analyze results
  • Verify data (double check)
  • Work with other analysts in organizing the release and stability analyses of the laboratory
  • Follow up deviations, incidents and validate the results within a LIMS system.
  • Support the implementation of the pharmacopeial testing by evaluating new product or techniques
  • Support investigation with the team or with the commercial QC

Who are you?

  • You hold a bachelor degree (or master’s degree), in biochemistry or in analytical chemistry
  • A good experience and expertise in pharmacopeia testing as particles matter measurement, appearance of product, osmolality, pH, water content, etc.
  • A good knowledge of GMP standards in QC laboratory
  • Good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
  • Good knowledge of English (ability to read scientific documents)

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]

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]ls.be 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

Facilities Maintenance Specialist

  • Location: Région Louvain-la-Neuve
  • Type: Perm
  • Job #19694

Facilities Maintenance Specialist (H/F/X)

CDI – Région Louvain-la-Neuve

#maintenance #électromécanique # électromécanicien #pharma #pharmaceutique #améliorationcontinue #sécurité #GXP #GMAO #CMMS

La maintenance à tous ses niveaux (mécanique, électrique, HVAC, automation) vous passionne ? Et le secteur pharmaceutique, en perpétuelle évolution, est votre terrain de jeu favori ? Alors, pourquoi ne pas conjuguer ces affinités et devenir Facilities Maintenance Specialist chez notre partenaire ?!

Dans ce job varié et à responsabilités, en collaboration avec votre Teamleader, vous aurez l’opportunité de manager une équipe de techniciens et de prendre ainsi part au bon fonctionnement de tous les départements de l’entreprise. Envie de relever des défis techniques et de faire partie d’une société en plein essor ? Alors, pas un instant à perdre ! Postulez et discutons ensemble de vos aspirations professionnelles !

Quelles sont vos responsabilités ?

  • Être présent dans tous les domaines où la maintenance est nécessaire : équipements de production, HVAC, électricité, mécanique, automation
  • Analyser, prioriser et répartir les tâches au sein du département Maintenance
  • Proposer des solutions d’amélioration continue et en assurer le suivi dans le respect des bonnes pratiques (GxP)
  • Former les collaborateurs et les nouveaux entrants
  • Être garant de l’application des règles de sécurité
  • Assurer le suivi des équipes de sous-traitances
  • Assurer l’écriture et la mise à jour de tout ce qui touche aux plans d’infrastructures et à la documentation
  • Être le back-up du Teamleader dans le suivi des tâches administratives et lors des audits

Qui êtes-vous ?

Bachelier en Electromécanique, vous avez minimum 5 années d’expérience, idéalement dans le secteur pharmaceutique. Les secteurs chimique, agro-alimentaire ou biotechnologies sont également valorisés.

Vous possédez des notions en GxP.

Vous maîtrisez un ou plusieurs logiciels de GMAO, ainsi que la suite Office

Vous êtes rigoureux, précis et convaincu de l’importance des procédures.

Vous faites preuve de team spririt avec une affinité pour la gestion d’équipe.

Vous avez une bonne compréhension de l’anglais.

Que pouvez-vous espérer ?

Outre une rémunération annuelle brute attractive et à la hauteur de vos compétences, votre package comprend un véhicule de société, assorti d’une carte carburant, des chèques-repas, écochèques, ainsi que les avantages liés à la CP207 (Chimie).

Sans oublier, qu’en rejoignant les équipes de notre partenaire, vous intégrerez une société en pleine expansion avec des possibilités d’évolution et d’apprentissage ! Convaincu ? Alors, faites-le nous savoir et discutons de vos attentes professionnelles !

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

QC Technician

  • Location: BRAINE-L'ALLEUD
  • Type: Perm
  • Job #15320

 

QC TECHNICIAN

#technicien #QC #HPLC #chimie #laboratoire #OOS #technician #API  #analyses 

INTRODUCTION

Le secteur pharmaceutique vous intéresse et vous souhaitez exercer une fonction au sein d’un laboratoire ? Vous êtes orienté chimie et avez de bonnes connaissances en HPLC ?

Alors ce job est fait pour vous!

ORGANISATION

Actif dans le secteur pharmaceutique, notre client est une société en pleine expansion, qui a rapidement acquis une solide réputation produits de haute qualité. Afin de renforcer ses activités, il est activement à la recherche d’un Technicien de laboratoire QC.

FONCTION

Au sein du laboratoire central, vous assurez la réalisation et la documentation des analyses pour toutes les activités du site. A ce titre, vos missions principales sont :

– La réalisation des analyses d’API et des produits finis, les contrôles in-process dans le respect du planning et des procédures en vigueur ;

– L’initiation et la documentation des ‘Out of Specifications ‘ (OOS) avec information de la hiérarchie ;

– La participation aux investigations de laboratoires liées aux OOS et aux déviations ;

– L’entretien et la bonne utilisation des équipements de laboratoire ;

– La participation à la gestion des stocks de consommables ;

– Rapporte au QC Manager.

 

PROFIL

– Dispose d’un bachelier en chimie ;

– Connaît les méthodes d’analyse suivantes : HPLC, UV, infrarouge, Karl Fisher,…. ;

– A un esprit positif, un sens critique, est orienté qualité et orienté client ;

– Sait utiliser les programmes de la suite Office ;

– Dispose d’une compréhension à la lecture de l’anglais technique.

OFFRE

Notre client vous offre un package salarial attractif complété d’avantages extra-légaux et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant.

Si vous êtes intéressé(e), n’hésitez pas à me contacter, Stevio Romano via [email protected]