Job Category : Life Sciences

Project Engineer Data Integrity

  • Location: 2000
  • Job #26972

Project Engineer Data Integrity

Contracting – Antwerp

Belangrijkste Taken en Verantwoordelijkheden

De aandacht voor Data Integrity (DI) groeit explosief, en bevat een prominente rol in audits. DI is allang geen lijstje ALCOA-regels meer – het is uitgegroeid tot een cruciale kwaliteitsmotor die continu evolueert.

  • Snel ownership nemen over eigen projecten ter ondersteuning van de Local Process Owner Data Integrity.
  • Verschillende projecten trekken die gericht zijn op het verbeteren of uitrollen van processen die voor de volledige site van toepassing zijn.
  • Samenwerken met diverse afdelingen (computerized systems, productie, quality, maintenance, …).
  • Een breed en veelzijdig intern netwerk opbouwen.
  • Zorgen voor een tijdige, kwalitatieve en budgetconforme oplevering van projecten.
  • Zowel zelfstandig als in team effectief werken, afhankelijk van de projectnoden.

Kwalificaties
Opleiding en/of Ervaring

  • Master opleiding
  • Perfecte beheersing van het Nederlands en het Engels
  • Kennis van productie- en labo-processen en equipment en/of van computer systemen
  • Ervaring in een GMP omgeving
  • Een eerste ervaring met Data Integrity is een mooie plus, maar geen vereiste.
  • Ervaring of sterke interesse in projectgebonden werk. Je weet in projecten en processen een goede balans te vinden tussen compliance en efficiëntie
  • Vlot overweg met verschillende digitale applicaties en MS office
  • Communiceert helder en respectvol, zowel mondeling als schriftelijk / gesprekspartner
  • De consulent beschikt over voldoende geduld en strategisch inzicht om afdeling overschrijdende projecten tot een goed eind te brengen
  • De consulent werkt gestructureerd en met oog voor detail: bewaakt overzicht, stelt prioriteiten en levert steeds nauwkeurig en betrouwbaar werk af
  • Vertrouwd om projectplanningen op te stellen, te presenteren en te volgen.
  • Het succesvol coördineren en uitvoeren van projecten van begin tot eind

Ons aanbod 

Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot opleidingen, zowel technisch als op het vlak van soft skills. Wij worden jouw carrièrepartner en begeleiden je bij elke stap in je professionele groei.
Ben je geïnteresseerd in deze functie? Dan nodigen we je graag uit om te solliciteren of je cv te sturen naar [email protected].

QC Specialist

  • Location: Braine-l'Alleud, Région wallonne, Belgique
  • Job #26971

QC Specialist

Contracting – Brabant Wallon

Your responsibilities:
The recruitment is to support a complex issue related to PEG, in collaboration with a QC specialist.
The work involves technical investigations on polymers, with connections between current analyses, methods, and validations.

  • Follow-up on deviations and quality issues related to PEG.
  • Analyze and understand unusual results.
  • Collaborate with regulatory specs, analytical development, method redesigns, transfers, and production.
  • Participate in quality committees on Tuesdays and Thursdays.
  • Use analytical techniques (HPLC, GC, IR, NMR) and software tools (Empower, Cromeleon).

Your profile:

  • Pharmaceutical experience (submission files, regulatory knowledge).
  • Proactivity, autonomy, ability to raise issues and suggest solutions.
  • Strong skills in organic and analytical chemistry (HPLC, GC).
  • Fluent in French and proficient in English (for international meetings).
  • Understanding of production processes and their analytical impact.
  • Master’s degree or technician with 5+ years of experience.

Nice to Have:

  • Familiarity with the lab and internal techniques.
  • Experience handling quality deviations.
  • Knowledge of Empower or Cromeleon.
  • Additional skills in IR, NMR.

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]
 

Internal Operations Quality Partner

  • Location: Braine-l'Alleud, Région wallonne, Belgique
  • Job #26936

Internal Operations Quality Partner

Contracting – Brabant Wallon

Your responsibilities:
The role is within the Clinical Supply Quality team, focusing on packaging and labeling for clinical studies. The position is critical for ensuring quality systems and compliance in the production, release, and distribution of Investigational Medicinal Products (IMPs) for clinical trials.

– Review of batch records (both electronic and paper).
– Review and release of labels.
– Release of warehouses and production consumables specification.
– Update of CEC (Controlled Environment Conditions).
– System-related activities: deviation review, CAPA (Corrective and Preventive Actions), change control.
– Temperature excursion management.
– Validation activities related to computer design systems.
– Documentation review for operational production activities.
– KPI realization based on specific requests.
– Participation in audits, regulatory inspections, and vendor management.
– Support for qualification, validation, and maintenance of equipment and facilities.

Your profile:
– 3 to 5 years of relevant experience required.
– Pharmaceutical experience is essential; QA/compliance experience in a pharmaceutical regulated environment.
– Proficiency in Excel (KPI creation, pivot tables).
– Hands-on operational QA experience is important and will make a difference.
– Good knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese).
– Technical affinity (e.g., point of contact for equipment validation).
– Dynamic, energetic, and communicative personality, able to challenge and express opinions.
– Fluency in English and French.
– Preferably a Master’s degree in engineering or similar for the right mindset.
– Ability to function with minimal supervision, strong organizational and analytical skills.
– Fact-based decision-making and problem-solving skills (failure investigations, risk analysis).

—- No QP (Qualified Person) number required, but QP training is a plus.

Nice to Have:
– Certified auditor by official authorities.
– Eligibility to act as a QP in the EU.
– Experience in leading internal audits/self-inspections.
– Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing, and Controls) documentation.
 

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]

Batch Record Reviewer

  • Location: Antwerp
  • Job #26943

Batch Record Reviewer

Contracting – Antwerp

De Batch Record Reviewer is verantwoordelijk voor het voorbereiden, controleren en finaliseren van batchrecords.
Je maakt deel uit van het Batch Record Review Team, een divers team dat batches voorbereidt en beoordeelt binnen de verschillende productie-eenheden.
Nauwe samenwerking met Operations en Quality over de afdelingen heen is essentieel voor deze rol.

Belangrijkste Taken en Verantwoordelijkheden

  • Uitgebreide review van productie- en reinigingsbatchdocumentatie.

  • Opstellen van batchtrends voor elke productie- en reinigingsbatch en controleren op volledigheid en eventuele afwijkingen.

  • Aanvullen van batchdocumentatie met noodzakelijke bijlagen (bijv. eLIMS-resultaten).

  • Controleren van volledig en correct grondstofverbruik.

  • Verifiëren, registreren en opvolgen van afwijkingen binnen elke batchrecord.

  • Correct classificeren van afwijkingen volgens procedures en, indien nodig, initiëren van non-conformiteiten.

  • Archiveren van batchrecords conform de kwaliteitsrichtlijnen.

  • Voorbereiden en structureren van batchdocumentatie.

Kwalificaties

Opleiding en/of Ervaring

  • Je kunt documentatie nauwkeurig en punctueel beoordelen.

  • Je werkt gestructureerd en kunt effectief prioriteiten stellen.

  • Je beschikt over sterke communicatievaardigheden.

  • Je spreekt en leest vloeiend Nederlands.

    Ons aanbod
    Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot opleidingen, zowel technisch als op het vlak van soft skills. Wij worden jouw carrièrepartner en begeleiden je bij elke stap in je professionele groei.
    Ben je geïnteresseerd in deze functie? Dan nodigen we je graag uit om te solliciteren of je cv te sturen naar [email protected].

Quality system contractor

  • Location: Braine l'Alleud
  • Job #26926

Quality System Contractor
Brabant Wallon – Contracting

What are your responsibilities?

  • Support and prepare for regulatory inspections and audits.
  • Lead or assist in Quality Council and Risk Management Committee activities.
  • Develop and maintain internal audit and self-inspection programs.
  • Structure and align local documentation with global standards.
  • Implement and lead local Quality System Reviews.
  • Promote quality culture and regulatory awareness among staff.
  • Act as a mentor/coach for quality and regulatory requirements.
  • Benchmark industry trends and support local/global quality initiatives.

Who are you?

  • Minimum 8–10 years of experience required in pharmaceutical quality systems.
  • Pharmaceutical industry experience.
  • Demonstrated experience in quality systems and compliance.
  • Experience in audits and inspections.
  • Ability to work autonomously and proactively.
  • Fluent in French and English.
  • Strong interpersonal skills; not afraid to reach out and follow up with colleagues.

Nice to have:

  • Experience with biological drug substance (business and/or quality).
  • Agility to handle unpredictable changes and a stressful environment.
  • Experience collaborating and influencing across departments.
  • Additional certifications in quality or regulatory affairs. 

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 invite you to apply!

Analytical Scientist

  • Location: Braine l'Alleud
  • Job #26914

Analytical Scientist

Contracting – Brabant Wallon

Your responsibilities:

  • Work on projects involving polymers, peptides, small molecules, and biomolecules.
  • Identify unknown impurities from production samples.
  • Develop analytical methods (high-resolution LCMS).
  • Participate in weekly project meetings.
  • Independently manage planning and lab work.
  • Prepare samples, process data, write reports, and present results.
  • Collaborate with the team to share instruments and knowledge.

Your profile:

  • Experience in mass spectrometry (high-resolution LCMS).
  • Skills in analytical method development.
  • Autonomous work style and ability to manage own schedule.
  • Good English proficiency (for meetings and international interactions).
  • Understanding and respect for GMP rules.
  • Ability to interpret complex spectra, especially for polymers and biomolecules.

    Nice to Have:

  • Experience with polymers and large molecules.
  • Knowledge of biomolecules (proteins, antibodies).
  • Experience in a GMP environment.
  • Willingness to collaborate and support teammates.
  • Familiarity with various mass spectrometry instruments.

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]

Lab Analyst

  • Location: PUURS
  • Job #26881

Lab Analyst
Contracting – Antwerpen
Verantwoordelijkheden

  • Uitvoeren van validatiestudies en testen in het kader van routine herkwalificaties en kwalificaties van nieuwe sterilisatiesystemen.
  • Testen uitvoeren volgens testscripts opgesteld door de betrokken projectingenieur.
  • Verwerken, evalueren en rapporteren van testresultaten volgens GMP-richtlijnen.
  • Coördineren of zelf uitvoeren van onderzoeken bij afwijkende of niet-conforme resultaten.
  • Actualiseren van GMP-documentatie (protocollen, rapporten, procedures) na uitvoering van de studies.
  • Opleiden en ondersteunen van nieuwe teamleden binnen het validatieteam.
  • Waken over veiligheid, kwaliteit en naleving tijdens alle validatieactiviteiten.

Profiel

  • Bachelor in een wetenschappelijke richting (chemie, biotechnologie, farmaceutische technologie, …) of gelijkwaardig door ervaring.
  • Ervaring binnen een GMP-omgeving en/of met validatieprocessen is een pluspunt.
  • Perfecte kennis van het Nederlands en een goede kennis van het Engels (schriftelijk en mondeling).
  • Analytisch en probleemoplossend vermogen met oog voor detail.
  • Sterke communicatieve vaardigheden en een echte teamspeler.
  • Technisch inzicht en interesse in technologie (meetapparatuur, software, automatisering, …).
  • Goede technische schrijfstijl en nauwkeurige manier van werken.
  • In staat om prioriteiten te stellen en zelfstandig te werken.
  • Veiligheids- en kwaliteitsbewust.
  • Bereid om te werken in een tweeploegenstelsel (6u–14u en 14u–22u).

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]

MSAT process engineer

  • Location: Geel
  • Job #26839

MSAT Process Engineer

Contracting – Antwerp

Your responsibilities:
The Manufacturing Science, Analytical and Technology department (MSAT) represents the scientific backbone of the company that provides commercial manufacturing support, process/method optimization (lifecycle management), technology transfer of new products and processes/methods and innovative, robust, and cost-effective next-generation processes/methods. To accommodate these complex scientific roles, the MSAT has extensive state-of-the-art laboratory capacity on site to develop and implement lab-scale models and analytical methods.

The company has engaged in a company-wide digitalization program that aims to integrate all (non-GMP) MSAT laboratory-related activities into iLab, a software package that is completely transforming the daily lab activities from paper-based to digital (including raw material inventory, notebooks, task management, data management) and allow for data collection and analysis on a global scale. This digital transformation entails the development of electronic notebook methods and the connectivity of laboratory equipment to ensure an efficient way of working.

Your profile:

  • You are familiar with laboratory informatics e.g. laboratory and data management systems and digital lab solutions
  • You have a PhD or master in Life Sciences, with relevant experience of minimum 3 years in biotech process/analytical development or MSAT-like functions.
  • Since all writing is in English and given the international context, you are fluent in writing and talking in English.
  • You are used to work in a lab environment and have specific experience in growing mammalian cells in bioreactors and/or protein purification and/or analytical assays.
  • You are flexible to adapt to changing priorities and willing to learn at a rapid pace.
  • You have affinity with IT systems and have an exploratory mindset to search for digital solutions in a laboratory environment.
  • You are a strong and spontaneous communicator who is eager to resonate with people across an organization, discuss and find compromises with people from different MSAT sub-teams.
  • You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail.

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]

Quality Project Associate

  • Location: Puurs
  • Remote: Remote
  • Job #26838

Quality Project Associate

Contracting – Antwerp

Your responsibilities:

  • Product Quality as the independent quality authority for product-related qualifications and validations of the assigned products.
  • Compliant and right first-time product launches within Quality Operations (QO)  
  • Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings

Validation
Act as quality authority in a consistent way, in compliance with cGMPs and current regulatory expectations, for the following qualification and validation documents:

  • Process qualification/validation
  • Method validation
  • Filter validation
  • Component qualification
  • Raw material evaluation
  • DHF

Registration
The composition, production processes, specifications, analytical methods of the drug products are described in the registration dossiers of the different markets. The QPA is responsible for pursuing regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved by participating in the following processes:

 

  • Data verification and QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings;
  • Performing compliance checks of the registration dossiers of the different markets versus the site practice.

Implementation
Ensure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets.

Your profile:

  • Master’s degree in scientific discipline
  • 2 years of relevant experience in the pharmaceutical sector and/or medical device industry with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for pharmaceutical products.
  • Quality mindset
  • Pragmatic
  • Excellent analytical and problem-solving skills
  • Excellent oral and written communication skills and social skills
  • Scientific knowledge and skills
  • Languages: fluent in Dutch and English
  • Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.

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. Are you interested in this job? We kindly invite you to apply or send me your CV, [email protected]

R&D packaging technologist

  • Location: LOVENDEGEM
  • Job #26773

R&D Packaging Technologist
West Flanders – Contracting
What are your responsibilities?
As an R&D Packaging Technologist, you develop, test, and homologate new or innovative packaging solutions by collaborating with cross-functional teams, to ensure product integrity, sustainability, and alignment with business objectives, which meet customer needs, compliance standards, and operational efficiency.
Pro-actively lead collaboration with cross-functional partners to develop robust packaging pipelines across innovation, renovation, sustainability and margin management, based on consumer needs and business strategy

  • Build and maintain strong relationships with internal and external cross-functional stakeholders to broaden perspective, identify areas of opportunity, leverage capabilities, apply outside-in thinking and effectively influence and gain support for initiatives, and deliver winning packaging solutions
  • Assist in the development and improvement of prototypes, tooling, and pilot production processes, contributing to product enhancement. for internal and external evaluation
  • Support sustainability initiatives by researching and evaluating sustainable materials, recyclability, and lightweighting opportunities. Contribute to packaging material reduction projects without compromising product integrity or consumer experience
  • Ensure packaging materials and processes adhere to local and international regulations, including safety, labeling, and environmental guidelines
  • Stay updated on industry standards and contribute to ensuring compliance across all packaging solutions
  • Communicate to business partners progress, risks and changes on active projects and influence decisions informed by deep consumer-, technical- and business understanding
  • Fulfill and maintain accurate records of packaging specifications, testing data, and project milestones. Prepare reports summarizing findings, project updates, and recommendations
  • Stay abreast of packaging technology developments, regulatory landscape changes and competitive packaging activity to grow awareness and make informed decisions

Who are you?

  • Have minimum 3 years’ experience on the same position or equivalent approach.
  • Possess a Food Technology Degree, Engineering and / or with operations equivalent experience.
  • Certifications in packaging-related disciplines are a plus.
  • Creativity to generate innovative packaging solutions, approaches and ideas.
  • Experience in packaging development, preferably within food, consumer goods, or pharmaceutical industries.
  • Familiarity with manufacturing processes and packaging machinery.
  • Have knowledge related to food legislation, hygiene and safety.
  • Knowledge of packaging materials (e.g., plastics, glass, paperboard) and their applications.
  • Experience with packaging testing methods and quality assurance protocols. Proficiency in software for packaging design and analysis.
  • Fluent in English.
  • Open minded approach to be close to the market to learn the state-of-the-art solutions in place or in progress.
  • Have a clear cross functional attitude, promoting interaction and constituting a key pillar for collaboration within areas and with external agents.
  • Effective communication and teamwork skills to collaborate across departments.
  • Resilience to bounce back from setbacks, adapt to change and persevere through challenges.

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.