Digital Lab Systems Engineer Contracting – Antwerpen Verantwoordelijkheden
Beheren van de volledige lifecycle van geautomatiseerde labsystemen binnen QC-, MSAT- en productiesites.
Ontwikkelen, implementeren en onderhouden van architectuur- en ontwerpspecificaties, evenals installatie-instructies voor nieuwe systemen.
Evalueren van systeemprestaties, identificeren van verbeterpunten en implementeren van optimalisaties.
Samenwerken met vendors, business experts (QC, MSAT, MFG) en QA/validatie-experts om conforme, veilige en betrouwbare systemen te garanderen.
Ondersteunen van validatie- en onderhoudsactiviteiten voor GxP-labapplicaties.
Fungeren als L3-expert en ondersteuning bieden aan het lokale supportteam waar nodig.
Zorgen voor back-up, restore en disaster recovery-plannen en het uitvoeren van periodieke testen.
Profiel
Sterke technische achtergrond met kennis van Microsoft-besturingssystemen, netwerken en scripting (PowerShell, VBScript, …).
Ervaring met validatie- en kwalificatiemethodologie binnen een GxP-omgeving.
Grondige kennis van GMP, GAMP5 en 21 CFR Part 11.
Nauwkeurig, analytisch en kwaliteitsbewust.
Zelfstandig maar ook een echte teamspeler.
Proactieve houding met sterk gevoel voor ownership.
Goede communicatieve vaardigheden en probleemoplossend vermogen.
Ervaring in een gelijkaardige rol is een pluspunt.
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]
Production Technician Codev Contracting – Production Technician CodevAntwerpen Verantwoordelijkheden
Opvolgen en ondersteunen van productieactiviteiten, waaronder formulatie, afvulling en inspectie, uitgevoerd door productie-operatoren.
Opstellen van ondersteunende documenten voor productieactiviteiten, zoals Master Batch Records en aanvragen voor laboratoriumanalyses.
Effectief samenwerken met multidisciplinaire teams, waaronder Project Engineers, Pilot Plant Operators, QC-laboratoria en andere stakeholders.
Werken binnen diverse digitale systemen zoals SAP, IPL en andere productieapplicaties.
Technische en administratieve ondersteuning bieden aan de klinische productie- en ontwikkelingsactiviteiten.
Zorgen voor correcte labeling en verpakking van monsters voor wereldwijde distributie.
Flexibel werken in een ploegensysteem (ongeveer 80% in ploegen, 20% dagwerk).
Profiel
Hands-on mentaliteit en sterke “can-do” attitude – iemand die graag de handen uit de mouwen steekt om resultaten te behalen.
Kan zelfstandig én in teamverband werken, met duidelijke en effectieve communicatie.
Positieve teamspeler met uitstekende interpersoonlijke vaardigheden.
Ervaring in een GMP-omgeving is een pluspunt (bijv. labo, productie of ziekenhuisomgeving).
Voelt zich comfortabel in een dynamische, snel veranderende omgeving met wisselende prioriteiten.
Nauwkeurig, detailgericht en kwaliteitsbewust.
Goede kennis van Microsoft Office (Word, Excel, PowerPoint, Outlook).
Goede kennis van het Engels; kennis van het Nederlands is een plus.
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]
Project & Process Lead Contracting – Antwerpen Verantwoordelijkheden
Leiden en ondersteunen van projecten vanaf de initiatie tot en met overdracht, inclusief engineering, aanbesteding, constructie, commissioning en projectopvolging.
Ondersteunen of leiden van deelprojecten binnen grotere projecten, inclusief aansturen van subteams of specifieke scopes.
Uitvoeren en coördineren van haalbaarheids- en engineeringstudies, in nauwe samenwerking met interne engineers, SME’s en vaste aannemers.
Bewaken van projectplanning, budget en kwaliteit gedurende de volledige projectcyclus.
Toezicht houden op veiligheid en naleving van GMP-richtlijnen tijdens alle fasen van het project.
Rapporteren aan de Engineering Manager en zorgen voor een vlotte communicatie tussen de verschillende stakeholders.
Profiel
Master of Bachelor in een technische richting (bijv. industrieel ingenieur, proces-, mechanisch of chemisch ingenieur) of gelijkwaardig door ervaring.
Minstens enkele jaren ervaring in de farmaceutische sector of een vergelijkbare gereguleerde omgeving.
Brede kennis van projectmanagement en -controle, met inzicht in alle fasen van de projectcyclus.
Technische kennis van utilities (HVAC, energie, perslucht, …) en processen binnen een GMP-omgeving.
Ervaring met constructiemanagement en commissioning.
Kennis van GMP-processen (change control, area classification, …).
Inzicht in veiligheidsprocedures (werkvergunningen, LOTO, …).
Sterke people skills en ervaring met change management.
Communicatief, analytisch en resultaatgericht.
Vlot in Nederlands en Engels, zowel mondeling als schriftelijk.
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]
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]
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]
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]
Category Associate, Real-World Evidence and Medical Affairs
Contracting – Brabant Wallon
Your responsibilities: – Support sourcing strategies and supplier management for R&D outsourced activities. – Collect and analyze spend data, contribute to strategic sourcing and contracting. – Participate in commercial negotiations and drafting of Master Service Agreements. – Attend meetings independently, manage stakeholder relationships, and contribute to procurement initiatives. – Administrative tasks such as tracker updates, savings recording, and report generation.
Your profile: – 3 years’ experience. – Experience in pharmaceutical industry (clinical environment preferred). – Procurement knowledge: sourcing processes, strategic support, contracting. – Fluency in English & French. – Strong stakeholder management, communication skills, and ability to work independently. – Contract drafting and negotiation skills. – Understanding of conversion models and commercial negotiations.
Nice to have: – Experience in data analysis and collection. – Familiarity with sustainability initiatives and risk management. – Ability to contribute to supplier relationship management and market intelligence. – Experience in project management and change management.
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]
Develop, optimize, execute and/or transfer liquid-chromatography coupled to mass spectrometry (LC-MS) methods.
Act as expert for analytical HPLC and mass spectrometry.
Integrate characterization LC-MS data with process/product knowledge.
End-to-end method responsibility, starting with method development and optimization up to method execution, data reporting and documentation.
Experience with common analytical workflows (peptide mapping, release glycans) is a plus.
Identification of improvements for existing methods to introduce new technology, increase method robustness, and reduce release cycle time.
Investigational support for product and process, generation of scientific/technical study protocols and report. Impact assessment upon signification deviations in the analytical methods, production process and providing technical/scientific expertise.
Support analytical activities for product characterization, transfer and process improvements for products in late development, next-generation, or commercial phase.
Profile:
PhD or Master in Life Sciences with mass spectrometry experience – mandatory, or equivalent through relevant experience.
Prior hands-on experience with LC-MS is a must.
Experience with large molecule LC-MS data interpretation (at intact of peptide levels) is a plus.
Good fundamental understanding of chromatography methods and mass spectrometry and can rely on this knowledge to accelerate projects and support troubleshooting. Prior hands-on experience with LC-MS troubleshooting is highly desired.
At least 3 years of relevant experience in method development, validation, and investigation testing/support in an analytical function. This experience can be acquired as company or academic experience.
Good understanding of GMP and the manufacturing and testing of biologics.
Quality-oriented mindset.
Fluent in writing and speaking in English.
Flexible and willing to adapt to changing priorities and willing to learn at a rapid pace. You are willing to support small-scale studies, quality investigations and MSAT-driven projects both in the lab and as part of a cross-function team.
Excellent analytical problem-solving mindset, you are accurate and have an eye for details
Familiar with various statistical and data trending techniques.
Strong communicator, who can connect, go into discussion, and find compromises with people in other departments or sites.
English, fluent in writing and speaking
Mostly Dutch speaking environment/team
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]
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.
Ontwikkelen, implementeren en uitvoeren van URS, SIA, DQ, IQ, OQ, PQ, RV en TM activiteiten voor kleinschalige apparatuur, inclusief de bijhorende software.
Opzetten en uitvoeren van validatiestudies voor cGMP-kritische processystemen om compliance met cGMP, gebruikers- en regelgevingsvereisten aan te tonen.
Uitvoeren van kwalificaties van systemen waar industriestandaarden bestaan maar interpretatie vereist is, conform cGMP, cGLP’s en Sanofi-procedures.
Zorgen dat de gekwalificeerde status van systemen steeds cGMP-conform blijft.
Ondersteunen van projecten in lijn met cGMP-regelgevingsnormen.
Op de hoogte blijven van nieuwe validatieregels en testpraktijken, en technische ondersteuning bieden m.b.t. FDA- en EU-vereisten.
Beheren van validatiedocumentatie van opmaak tot goedkeuring en implementatie.
Input leveren bij change assessments om te bepalen of wijzigingen impact hebben op de gekwalificeerde status en documentatie.
Profiel
Grondige kennis van cGMP-vereisten in een gereguleerde omgeving.
Begrip van relevante kwaliteits- en compliance-regelgeving.
Probleemoplossend en in staat om validatie-issues te troubleshooten.
Goede kennis van Quality Management Systems.
Ervaring: 2–4 jaar in een farmaceutische of healthcare productieomgeving, met specifieke ervaring in kwalificatie van kleinschalige apparatuur en bijhorende software.
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]
