Job Category : Life Sciences

Process Engineer

  • Location: Wavre
  • Job #26170

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 7 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 layout.
  • 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,…) 

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] 
 

QA External Supply

  • Location: Wavre
  • Job #26169

QA External Supply 

Brabant Wallon – contracting 

What are your responsibilities?

  • Be accountable for technical management including risk management, deviation ownership, change control authoring and coordinating, Product Technical Specification (PTS) and Method of Production (MOP) review and knowledge management. Participate to  CC Implementation committee.
  • Review and approve demand versus supply, assess the capacity available, identify potential risks to service and identify requirements to capacity adjustments to meet future volume projections. Give, understand and master the inputs/outputs of SRM meeting.
  • Ensure visibility is given on demand and supply information across the supply chain to ensure pro-active management and avoid out of stocks, performance management through set-up, measurement, monitoring and reporting of KPI’s
  • Drive continuous improvement projects with his/her CMO and with internal and external stakeholders in order to strengthen the CMO operational activities. Support continuous improvement for complex/transversal projects.
  • Give support to the QA team to ensure compliance of the ES operations with cGMP and Authorities requirements.
  • Timely escalate issues to Manager if required by internal process
  • Be accountable for reporting (KPI, monthly)

  • Be the back up of the SRM (Supplier Relationship Manager

    Who are you ? 

  • Experience (preferable 1-3 years) in the following :
    • (Bio)pharma & cGMP
    • Quality
    • Project management
  • Bilingual French/English (oral & written)
  • Proactive with ability to identify and follow up on gaps in process
  • Ability to work under pressure due to the requested flexibility and reactivity of the activities
  • Be able to manage short term issues with long term activities in parallel.
  • Ability to work in project teams in a multidisciplinary environment and a matrixial organization
  • Be able to lead and manage cross-functional projects
  • Excellent communication and negotiation 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.
    You’re interested in this job? We kindly invite you to apply.

Quality Specialist Operations

  • Location: PUURS
  • Job #26128

Quality Specialist Operations
Contracting – Anvers
Your Responsibilities:

  • Investigate and document QA-related deviations, escalating issues or providing recommendations to the Team Leader as needed
  • Coordinate cross-functional investigations involving manufacturing, packaging, labs, support teams, and third parties
  • Perform root cause analyses, define CAPAs, and verify their effectiveness to prevent recurrence
  • Report significant quality events to regulatory agencies (e.g., FAR, BPDR) in compliance with local and international regulations
  • Participate in operational meetings (Daily Operations Review, product/process teams)
  • Conduct trend analyses, evaluate corrective actions, and monitor effectiveness
  • Support continuous improvement initiatives aligned with GMP, quality, and performance KPIs
  • Contribute to team projects or initiatives as assigned by the Team Leader or Manager

Your Profile:

  • Degree in Bioengineering, Pharmacy, Biology, Biochemistry, Biotechnology, Chemistry, Engineering, or equivalent experience
  • Experience as a Qualified Person is a plus
  • Previous exposure to manufacturing, packaging, or laboratory environments
  • Experience with quality investigations and release of biological products or vaccines is preferred
  • Fluent in Dutch and English (written and spoken)
  • Strong analytical, problem-solving, and documentation skills
  • Excellent communication and stakeholder interaction abilities
  • Able to manage time effectively and prioritize tasks in a dynamic environment

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]
 

QA Engineering Services

  • Location: Geel
  • Job #25988

QA Engineering Services
Contracting – Antwerpen
Onze partner is op zoek naar een QA Engineering Services om hun team te versterken.
Wat zijn jouw verantwoordelijkheden?

  • Opstellen en reviewen van Quality documentation in kader van project (Project notes, Quality plannen, …)
  • Opvolgen en reviewen van general project documentation (risk assessments, validatie plannen, procedures, batch records, …)
  • Quality ondersteuning en expertise delen met betrekking tot klinische manufacturing en commercial manufacturing
  • Project documentatie (e.g. procedures, risk assessments) opmaken en reviewen met oog op deviation prevention (DPP) and human error prevention (HEP)
  • Compliance zijn met SOP’s, globale standaarden, regulations en product registratie (filing) met betrekking klinische en commerciele manufacturing
  • On the floor GMP support, inclusief uitvoeren van GEMBA’s.
  • Cross-departementele samenwerkingen ondersteunen
  • Weten wanneer issues/QA events geëscaleerd dienen te worden naar supervisor/manager

Jouw profiel?

  • Master in een wetenschappelijke richting of gelijkwaardig door ervaring
  • Kennis en interpretatie van cGMP in een gereguleerde omgeving
  • Kennis en interpretatie van klinische manufacturing en regulations is een voordeel
  • Kennis en ervaring met Quality Processen en Quality Assurance
  • Uitmuntende nauwkeurigheid en oog voor detail
  • Zelfstandigheid en een sterk verantwoordelijkheidsgevoel
  • Een enthousiaste teamplayer en sterk in communicatie
  • Goede writing skills
  • Goede kennis van de Engelse taal

Ons aanbod?
Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot trainingen op technisch gebied en soft skills. Wij zijn je carrièrepartner bij elke stap in je carrière. Ben je geïnteresseerd in deze functie? Stuur een email naar [email protected]. We nodigen je van harte uit om te solliciteren

QA Validation

  • Location: Geel
  • Job #25987

QA Validation
Contracting – Antwerpen
Onze partner is op zoek naar een QA Engineering Services om hun team te versterken.
Wat zijn jouw verantwoordelijkheden?

  • Ontwikkeling, implementatie en uitvoering van URS-, SIA-, DQ-, IQ-, OQ-, PQ-, RV- en TM-activiteiten voor voornamelijk kleinschalige apparatuur. Ontwikkelt, implementeert en voert validatiestudies uit voor cGMP-kritische processystemen om aan te tonen dat ze voldoen aan de cGMP-, gebruikers- en regelgevingseisen. Er worden hands-on activiteiten in dit verband voorzien.
  • Voert validatie uit van systemen binnen de scope waarvoor er industriële precedenten zijn, maar waarvoor de normen per geval moeten worden geïnterpreteerd en in overeenstemming met cGMP, cGLP's en Sanofi-procedures.
  • Zorgt ervoor dat de gevalideerde status van systemen binnen de scope te allen tijde voldoet aan cGMP.
  • Zorgt ervoor dat projecten worden ondersteund in combinatie met alle vereiste Sanofi- en cGMP-regelgevingsnormen.
  • Blijft op de hoogte van nieuwe validatieregelgeving en validatietestpraktijken om te voldoen aan of te overtreffen cGMP-vereisten. Biedt technische ondersteuning voor de huidige
  • Validatievereisten van de Amerikaanse FDA en de EU. Genereert
  • Validatiedocumentatie (protocollen/rapporten) en biedt ondersteuning bij de uitvoering van protocollen voor systemen binnen het scopegebied.
  • Verantwoordelijk voor de validatiedocumentatie tot en met goedkeuring en implementatie.
  • Levert input bij de beoordeling/beoordeling van wijzigingen en geeft aan of deze van invloed zijn op de gevalideerde status en de validatiedocumentatie, indien van toepassing.

Jouw profiel?

  • Kennis van CGMP-vereisten in een gereguleerde omgeving.
  • Kennis van relevante kwaliteits- en compliancevoorschriften.
  • In staat om validatieproblemen op te lossen.
  • Goede kennis van kwaliteitsmanagementsystemen.
  • Ervaring: 2-4 jaar ervaring in een productieomgeving in de gezondheidszorg, met ervaring in het kwalificeren van kleinschalige apparatuur (inclusief de bijbehorende software).

Ons aanbod?

  • Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot trainingen op technisch gebied en soft skills. Wij zijn je carrièrepartner bij elke stap in je carrière. Ben je geïnteresseerd in deze functie? Stuur een email naar [email protected]. We nodigen je van harte uit om te solliciteren

QC engineer (micro)

  • Location: Geel
  • Job #25909

QC engineer (micro)
Contracting – Antwerpen
Our partner is looking for an QC Engineer to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?

  • Method validation BacTalert method for EFA unprocessed bulk:
  1. reporting + inspection readiness FDA or other external inspections
  2. method evaluation for cleaning samples -> define strategy/business case, validation requirements + set-up studies.
  • Recombinant Factor C (rFC) test method implementation on water samples as alternative for LAL testing. (reduction of animal related reagents for LAL testing)
  • Participate in global working group on the roll-out of rFC versus rCr(recombinant cascade reagents) for product testing: define strategy + validation requirements
  • Implementation of outsourced micro identification approach on the existing Maldi-TOF analyzer: goal: increase of micro identification levels with maldi – decommissioning identification with micro-seq(qPCR techno)
  • Digitization of micro method validations (bioburden/endotox): set-up of data structure to allow reporting out of lims. (goal: quicker validation turn around times)
  • Launch products: Low Endotoxin Recovery evaluation: implementation of required method changes to reduce the risk on low endotox recovery for new launch products
  • Supports operational team in the complex micro investigations
  • Screening new techno for automated plate counting on EM samples as well as on product samples (membrane filtration): business case evaluation together with global QC excellence team.

Your profile? 

  • Master in micro or biochemistry, at least 5 years experience
  • Experience in GMP method validation of alternative micro methods is recommended
  • Micro scientific knowledge required based on education or though experience
  • Strong in analytical thinking, teamwork, agile working,…
  • Experience with external compliance audits is a plus
  • Strong communication skills in writing and verbal

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.
 

QC Engineer

  • Location: Geel
  • Job #25904

QC Engineer 
Contracting – Antwerpen
Our partner is looking for an QC Engineer to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?

  1. Expertise in HPLC/GC and raw material analysis required (FTIR, Raman, spectrophotometry, refractometry, densitometry,…)
  2. Expertise in Ph.Eur, USP and JP pharmacopeal testing requirements
  3. Willing to perform hands-on work in the context of method implementation/validation
  4. Experience with Equipment validation and data integrity requirements for complex QC equipment and software e.g. HPLC, plate reader,                                                            User Requirements Specifications (URS). Installation qualification (IQ) and Operational qualification (OQ), Performance qualifications (PQ)
  5. Participates in analytical method transfers and/or validations: GAP assessments, SOP creation and associated training for new methods
  6. A plus if there is experience with digitization of work flows (in the context of paperless lab transformation)

Your profile? 

  • Master’s in chemistry, biochemistry or life sciences related
  • At least 5 years’ experience in GMP
  • QC experience in pharma
  • Technical skills through experience
  • Analytical thinking
  • Teamworking
  • Result oriented
  • Good documentation and writing skills in English.

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.
 

Production Engineer Medior

  • Location: PUURS
  • Job #25967

Production Engineer Medior
Contracting – Antwerpen
Onze partner is op zoek naar een productie-ingenieur (medior) om hun team te versterken. Dit internationale bedrijf staat bekend om zijn farmaceutische producten.
Wat zijn jouw verantwoordelijkheden?
Als Production Engineer Preparatie ben je het eerste aanspreekpunt voor alle technische
aspecten van onze preparatie processen.
De preparatie support groep speelt hierbij een cruciale ondersteunende rol. Dit enthousiaste
team van technische experten draagt kwaliteit en veiligheid hoog in het vaandel en slaagt er
telkens weer in om zijn grenzen te verleggen. Hun teamwork en expertise vormen de onmisbare
drijvende kracht achter de groei van onze afdeling.
Takenpakket

  • Identificeren, analyseren en wegwerken van bottlenecks en rendementsverliezen
  • Assisteren en coördineren van activiteiten bij technische breakdowns
  • Uitvoeren en documenteren van root cause onderzoeken in geval van kwaliteitsafwijkingen
  • Uitvoeren van data-analyse op de preparatieprocessen
  • Projectmanagement voor wijzigingen en optimalisatieprojecten binnen preparatie
  • Aanspreekpunt voor productie bij afdelings-overschrijdende projecten
  • Dagdagelijkse ondersteuning van productie

Jouw profiel?
Must have

  • Masteropleiding: industrieel ingenieur, burgerlijk ingenieur, bio-ingenieur, (industrie)apotheker.
  • Van gelijkwaardige deurervaring.

Nice to have

  • Ervaring in een relevante functie en omgeving
  • Ervaring in een GMP-omgeving
  • Ervaring in productieomgeving
  • Teamspeler
  • Geïnteresseerd in een sterke met techniek
  • Perfecte beheersing van het Nederlands en het Engels
  • Sterke interpersoonlijke vaardigheden
  • Communicatief sterk
  • Georganiseerd, nauwkeurig en zelfstandig kunnen werken

Ons aanbod?
Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot trainingen op technisch gebied en soft skills. Wij zijn je carrièrepartner bij elke stap in je carrière.
Ben je geïnteresseerd in deze functie? Stuur een email naar [email protected]. We nodigen je van harte uit om te solliciteren.
 

Maintenance Gatekeeper

  • 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]

 

HSE Compliance Officer

  • Location: Braine-l'Alleud
  • Job #25423

HSE Compliance Officer
We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).

The person will be responsible for managing environmental issues, including the « Licence to Operate » for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.

The Responsibilities

– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities
– Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO).
– Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities.
– Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services.
– External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.

Skills and Knowledge Requirements

– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management.
– Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders).
– Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting.
– Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset.
– Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site.
– ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement.
– Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings).
– Remote work is permitted when on-site presence is not required, but there are no fixed remote work days.
Additional Assets:
– Experience with Seveso risk management (hazardous materials storage).
– GMP (Good Manufacturing Practices) certification is a plus, but not required.
– Ability to ask questions and solve problems independently.

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]