Emploi Type : Contracting

Senior validation engineer (PQ)

  • Lieu: Braine-l'Alleud
  • Travail #24239

Senior validation engineer (PQ)

Brabant Wallon – contracting 

Our partner is looking for a Senior validation engineer to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

  • Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
  • Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
  • Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
  • Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
  • Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
  • Establish and monitor validation KPIs.
  • Review handover of equipment / systems from suppliers and or other project stakeholders.

Who are you ? 

  • More than 5 years of experience with PQ phase having led and managed validation projects, including sterile manufacturing.
  • Must have experience of working on projects; project management experience. We need someone who understands and knows what to do but not a PM expert.
  • Knowledge of safety, GMP and environmental regulatory requirements.
  • Expert in reviewing and writing technical reports.
  • EN is a must have
  • Ability to work with other persons – team spirit.
  • Homeworking : authorized, but must remain flexible according to project needs.

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. 

GMP Compliance

  • Lieu: RIXENSART
  • Travail #24233

GMP compliance
Our client
Our client is looking for a profile in GMP Compliance to join its team. The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.

Your responsibilities
– Release spare parts to be used on GMP equipment throughout the company plant.
– Contact the spare parts' supplier in case of further investigation to allow release of the spare parts. 
– Ensure on the floor presence and be the point of contact for the operational team.
– Participate to the strategy definition of the spare parts management and release.
– Ensure the correct application of the quality systems on the field and to define improvement plan as required.
– Process the backlog in release, investigations, and archives.
– Challenge the new spare parts creations.
– Review the modification proposed by the technical teams (MO).
– Quickly understand the regulatory requirements for the spare parts
– Use a risk-based approach for problem solving and prioritization of tasks
– Blow a quality and compliance mindset through the operational team
– Develop and continuously improve expertise linked to spare parts – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions

Skills and knowledge requirements
 – University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
– At least 5 years professional experience in pharmaceutical environment. 
 – Very good interpersonal relationship skills
– To be a good team player in order to success in each validation project.
– Fluent in French, good oral and written communication skills in English
– Problem solving and achievement oriented
– Knowledge of GMP Regulated environment
– Strong organizational skills

Our offer
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]
 

Powder Scientist

  • Lieu: Braine l'Alleud
  • Travail #24227

Powder Scientist
About our client
To strengthen our materials Science team, based in the Pharma Sciences Department in Braine, Belgium, our client is looking to fill the position of: Powder Scientist.

About your role
Would you say your scientific approach is passionate above all? As a Powder Scientist you like to work in an environment where you can:
· Participate to the development of new products and processes
· Give directions from early development up to lifecycle management, from particle design up to final product
· Work autonomous, well-organized and use your pro-active thinking skills
· Be self-reflective on the gathered data
· Use your creativity to develop new analytical methods or even develop new technology
· Drive team spirit and encourage collaboration

Your responsibilities:
· Being a leader in powder characterization by leveraging Materials Science to drive overall Product Development in order to obtain the right drug for every patient
· Guide the Product Development by connecting powder /particle insights with manufacturing technologies and overall product performance
· Combine particle knowledge with crystallization science to optimize expected powder properties
· Developing method and performing analyses on active ingredient, drug product and excipients in the field of powder characterization
· Independently planning, conducting and interpreting experiments to determine the bulk powder and particle properties of raw materials, intermediates and final dosage forms, by mastering a number of characterization tools: laser diffraction (wet and dry method) and microscopy (optical and SEM) for particle size and shape measurements; gas pycnometry and fine solid displacement methods for true and envelope density determinations; physisorption for surface area quantification and porosimetry; powder rheometry to assess powder flow stability and strain-rate dependency; shear cell testing to measure powder flow functions and wall friction with application to hopper design; surface energy and wettability analyses via contact angle measurements (sessile drop, Washburn and Wilhelmy plate methods), standardized and customized methods to evaluate bulk/tapped density, powder compressibility, permeability, mechanical strengths of tablets and/or agglomerates, electrostatic charging, segregation, sticking and caking propensity; dynamic vapor sorption to assess powder hygroscopicity; differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) to understand the powder thermal behaviour.
· Performing chemical imaging on drug product or intermediates
· Being the reference person in powder characterization and training colleagues
· Applying QbD principles, multivariate analyses, and being in support of PAT development
· Keeping track of literature and state of the art scientific practices, and implementing innovative solutions
· Communicating with stakeholders and external partners (universities, centres of expertise…)
· Writing reports and give internal and external presentations

Education, experience, and skills required:
· Master / PhD in chemistry, pharmaceutics, physics or engineering or equivalent experience, on powder characterization
· Fluent in English
· Ability to work at the interface
· Able to combine multiple tasks and work simultaneously on different projects
· Soft skills: entrepreneurship, motivated, enthusiastic, reliable, team player, good communication

Our offer
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]

Artwork Operations Coordinator

  • Lieu: Braine-l'Alleud
  • Travail #24222

Artwork Operations Coordinator

Contracting – Braine l'Alleud

What are the responsibilities?
Follow up the review of the Change Proposals and impact assessment documentation covering
E2E Artwork & Labelling process :

  • acknowledgement of change proposal reception
  • preparation of the kick off meetings in the context of change proposals
  • follow up the review of the change and impact assessment for Artwork
  • communication to stakeholders and change leader based on endorsement of the change in the context of Artwork
  • tracking of CP projects to ensure endorsement is done on time

Create and manage AW projects in artwork management system:

  • creation & scheduling of artworks projects;
  • performing AW Project Coordinator’s tasks as defined in AW management system;
  • coordination and tracking of the artwork creation and approval; follow-up of all project tasks to deliver the approved artworks respecting cross-functionally agreed timelines and other project due dates; keep the dues dates in the system up to date;
  • working in close collaboration with all involved internal and external stakeholders of the artwork projects.
  • mockup GARF approval, create and manage MU projects in artwork management system;
  • closing AW projects and GARF projects;
  • tracking of AW projects to ensure that tasks are completed on time and are kept aligned with deliverable expectations.

Experience and Knowledge requirement

  • Bachelor's degree or equivalent experience
  • Excellent computer literacy;
  • Experience in coordination and administrative tasks
  • Good communications skills and team spirit
  • Used to work in a multinational/multicultural environment
  • Fluent in English (written and oral), French is an asset
  • Experience from a Regulatory and/or Supply Chain environment is an asset.
  • Service minded with very good written and verbal communication skills
  • Problem solver
  • Structured, detail minded and well organized
  • Stress resistant, accepts to be challenged and to challenge others
  • Open minded, flexible and team oriented; capable of doing the extra mile to reach targets.

Our offer?
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 me.
 

Senior Electricity Engineer

  • Lieu: RIXENSART
  • Travail #24220
Purpose of the Mission
Engineering is primarily concerned with the installation and application of developed solutions, the maintenance of facilities, infrastructure, and equipment as well as the connection of services (water, chemicals, gases). Any other aspect in engineering like plant design, industrial programming, etc… may be concerned.

Primary Tasks & Responsibilities
• Individually or as part of a project team responsible for solution design and process layouts for electricity and instrumentation equipment including the following installations: instrumentation and machinery for power generation, power supply, electrical protection, small cabling, calibration and measuring devices, Telecom equipment (data, Wifi, Deadman) and electrical distribution MT (36-11kV) and BT (400-230V-48V-24V).
• Responsible for the execution, coordination and follow-up of solution designs and technical matters related to Process Control to ensure construction, transformation, commissioning, and qualification of the solution meets agreed cost, timing, technology, and quality standards in line with the Global Technical Services standards.
• Key activities include:
o Define functional, technical, and quality requirements.
o Realize process studies, P&ID’s and process layouts whilst considering the operating and EHS characteristics at all design steps.
o Ensure preparation and update of the project qualification and coordinate qualification activities of the installations.
o Ensure work inspections are issued in line with quality standards.
o Ensure systems legal conformity.
o Coordinate technicians during execution to secure contracts and connection of services (water, chemicals, gases) and electricity.

Experience, Knowledge & Soft Skill Requirements
• Demonstrates deep knowledge in design and implementation of engineering projects.
• Practical experience in project supervision and people management
• Perform his/her work in a cGMP consistent manner.
• Experience in the Pharmaceutical industry

Soft Skills:
• Good communication skills
• Good project management skills: organization, cost, time, schedule, contracting, procurement, qualification, validation, technologies.

Education, Methodology & Certification Requirements
• Industrial or Civil Engineer.

ICT Skills (software, operating systems, hardware, etc.)

  • MS Office
  • SAP

Language Proficiency Requirements

  • English: Business
  • French: Fluent

Our offer
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]
 

Technicien Bureau d’Etudes Electricité

  • Lieu: Liège
  • Travail #24213

Liège – Contracting (CDI)

#électricité #réseauélectrique #français #autocad #coreldesigner #bureau #technicien #dimensionnement

Pour notre client spécialisé dans le secteur de la distribution d'électricité, nous sommes à la recherche d'un Technicien Bureau d'Etudes Electricité.

Quelles sont vos responsabilités ?

Le rôle du Bureau d’Etudes Interne Electricité est d’étudier et d’optimiser les projets de raccordement, d’extensions, de renouvellement ou de déplacement, les projets de restructuration du réseau et ce afin de garantir la sécurité, la qualité et l’efficience du réseau Electricité.

Description

Dans le cadre du bon fonctionnement interne de l’organisation et de la prise en charge des problèmes liés à la transition énergétique (notamment la problématique des décrochages des onduleurs), l'entreprise souhaite renforcer son équipe du Bureau d’Etudes Interne Electricité.

Tâches principales:

  • Analyser les problèmes de tension (surtension / sous-tension) avec les outils adéquats mis à sa disposition, identifier le moyen le plus approprié pour les résoudre et les soumettre à l’un des responsables du bureau d’étude.
  • Être garant de la qualité des études (techniques) afin de garantir la sécurité, la qualité et l'efficience des réseaux.
  • Assurer le suivi des projets par l’encodage et l’archivage d’informations dans les applications propres à la section.
  • Procéder au chiffrage du projet sur base de prix unitaires appliqués en interne.
  • Participer à des réunions techniques avec différents auteurs de projets, nos associés, les clients internes et externes.
  • Réaliser des rapports de réunion afin d’informer le responsable du bureau d’étude.
  • Suivre les différentes formations nécessaires à l’exercice de la fonction.

Qui êtes-vous ?

  • Bachelier en Electromécanique / Electricité ou ingénieur technicien
  • Avoir les connaissances de base pour pouvoir à très court terme calculer, dimensionner et/ou optimiser un réseau électrique
  • Connaissance du français (C1 minimum)
  • Maîtrise des outils informatiques MS Office
  • Expérience avec Autocad
  • Expérience avec l'outil Corel Designer
  • Expérience dans le fonctionnement d'un bureau d'étude électricité est un atout
  • Minimum 3 ans d'expérience en tant que technicien ou ingénieur en électricité
  • En possession d'un permis de conduire (catégorie B)

Que pouvez-vous espérer ?

Jefferson Wells vous propose un CDI avec un package salarial attractif et vous donnera accès à des formations en matière technique et soft skills. Nous serons votre partenaire de carrière à chaque étape du processus.

Vous êtes intéressé.e par ce poste? N'hésitez pas à postuler!

HSE Construction Support

  • Lieu: Braine-l'Alleud
  • Travail #24211

HSE Construction Support

Brabant Wallon – contracting 

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

What are your responsibilities?

The role of the HSE Construction Support on the Genesis project is to implement the HSE strategy on the construction site in line with the project HSE strategy defined by the HSE Manager. The HSE Construction Support reports to the HSE Construction Manager. 

  • Carry out regular safety visits and site inspections (main part of the job) and write reports.
  • Participate in and follow up on actions defined at recurring meetings (whiteboard meetings, level 0 meetings, CSS, etc.). 
  • Participate in the investigation of accidents/near misses.
  • Assist in measuring and monitoring KPIs
  • Assist with documentation management (paper and digital on ACC / Sharepoint) 

Who are you ? 

  • Fluent in French & English 
  • Bachelor's in construction with a safety aspect, experience in site coordination (no pharma experience needed but would be a plus)
  • Mid-level profile – construction diploma
  • Proactive, assertive, organized, solutions-oriented

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. 

SME E&I

  • Lieu: Braine-l'Alleud
  • Travail #24210

SME E&I

Brabant Wallon – contracting 

Our partner is looking for a SME E&I to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

Act as the technical reference for contracts related to its area of expertise.

  1. Expert in his/her field of expertise
  2. Author of specifications, calculations and drawings relating to his field of expertise
  3. SPOC for contractors selected to build the facility in his field 
  4. Collaborate with the company package owner to manage the contract: planning, budget, quality of execution.

Who are you ? 

  • Knowledge in electricity, high and low current. Experience in electricity in the pharma field (data, access control, …).
  • Proven experience in CAPEX projects
  • 5+ years of experience in engineering for industrial and/or pharmaceutical environments
  • Experience in the biotech environment in the bio-pharmaceutical industry is preferred.
  • Knowledge of safety, GMP, and environmental regulatory requirements.
  • Experience in legal conformity and energization process (3 green lights), proven experience in qualification

• Soft skills:

  • Senior profile, minimum 10 years of experience in the field.
  • Proven experience in qualification; knowledge of Verification (ASTM E2500) is a plus
  • Good communication, rigorous, fully capable of acting on own initiative

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. 

Process & Solution Engineer

  • Lieu: OOSTAKKER
  • Travail #24183

Process & Solution Engineer
Vast Contract of Freelance – regio Gent
#Engineering #IT #DataAnalysis

Ben je geboeid door de wereld van technologie en Industry 4.0? Heb je een sterke interesse in IT en ben je gepassioneerd door data en innovatie, vooral binnen een uitdagende productieomgeving? Dan hebben we een geweldige opdracht die perfect bij jou past!

Voor een klant zijn we op zoek naar een Process & Solution Engineer regio Gent (m/v/x). Voel jij je klaar voor deze uitdaging? Wil je samen met Jefferson Wells aan de slag bij deze klant? Lees dan verder!

Jouw verantwoordelijkheden?
Als PSKU Engineer ben je verantwoordelijk voor het beheren en optimaliseren van het productie systeem, een balanceringsysteem voor de handelingen van arbeiders op de productielijnen.

  • Je zorgt voor data-analyse, detecteert bugs en optimaliseert de productieprocessen
  • Je verzameld data van diverse medewerkers zowel op nationaal als internationaal niveau
  • Je staat in voor de trainingen en opleidingen voor het gebruik van het systeem
  • Daarnaast werk je nauw samen met collega's PSKU Engineers om ervoor te zorgen dat het systeem efficiënt blijft draaien
  • Je zorgt voor de implementatie van nieuwe technologieën om het systeem te verbeteren. (Machine vision systemen, AI en Machine Learning, MES, ERP, IoT Platforms, …)
 

Wie ben je?
Om bovenstaande taken succesvol uit te voeren, beschik je als PSKU Engineer over een achtergrond in engineering of IT, en heb je affiniteit met data-analyse en optimalisatie van productielijnen. Je bent assertief, communicatief en houdt van het geven van opleidingen en trainingen aan collega's. Je beheert vlot de Nederlandse en Engels taal.

Net afgestudeerden zijn ook welkom voor deze job!

Wat kan je verwachten?
Als PSKU Engineer kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Sara Van den Bossche  op het nummer +32 (0)4 72 79 10 42 of via Sara.vandenbossche(@)jeffersonwells.be.

Dessinateur Catia V5

  • Lieu: ANGLEUR
  • Travail #24180

Liège – CDI

#Dessinateur #Projets #Design #Catia V5 #Mécanique #CAO

Pour notre partenaire spécialisé dans la conception et fabrication des systèmes optiques, mécaniques et opto-mécaniques pour l'astronomie et l'espace, nous recherchons un dessinateur Catia V5 pour une mission de 6 mois

Quelles sont vos responsabilités ?

  • Gérer la conception mécanique tout en assurant la faisabilité technique des produits confiés
  • Réaliser les plans nécessaires (plans d’ensemble et  de détails) en veillant à utiliser les outils mis en place
  • Comprendre et intégrer les différentes contraintes techniques d’un projet et les traduire en un produit réalisable et qui répond aux fonctions souhaitées.          
  • Réaliser les dossiers de plans contenant les informations nécessaires et suffisantes à la fabrication du produit (atelier, sous-traitant), en ce compris le tolérancement mécanique. 
  • Reporter l’état d’avancement du travail (ETC).   
  • Reporter les difficultés techniques rencontrées, les exigences contradictoires et proposer des solutions.

Qui êtes-vous ?

  • 3 ans d’expérience minimum en conception mécanique
  • Maitrise de CATIA V5
  • Maitrise de la cotation fonctionnelle, du tolérancement géométrique (GPS) et des méthodes d’industrialisation.
  • Bonne aptitude à travailler en équipe et à communiquer les informations liées au projet.
  • Connaissances en résistance et en propriétés des matériaux.

Que pouvez-vous espérer ?

Jefferson Wells vous propose un CDI avec un package salarial attractif et vous donnera accès à des formations en matière technique et soft skills. Nous serons votre partenaire de carrière à chaque étape du processus.

Vous êtes intéressé.e par ce poste? N'hésitez pas à postuler!