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]
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]
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]
Scientist, Injectable Drug Product Process Development
Walloon Brabant – Contracting
Major Responsibilities
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
Capture and analyze critical manufacturing process data for process understanding and process characterization ;
Perform process risk assessments ;
Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products) ;
Define the investigational medicine product preparation process in clinical trials ;
Provide support to ensure timely manufacture of stability and clinical DP batches ;
Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the client's quality system, cGMP and latest regulatory requirements ;
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities ;
Provide support in investigations of deviations and complaints related to DP quality ;
Support knowledge transfer from late phase development to commercial for validated DP processes ;
Contribute to develop the ways of working in the department.
Profile
Bachelor's Degree ;
2–3 years of experience in manufacturing or production support ;
Knowledge of fill & finish processes (even indirect) ;
Ability to work independently after a few months ;
Scientific critical thinking ;
Clear and transparent communication ;
Motivation and energy ;
Fluent English (documents, meetings, interactions) ;
Scientist grade.
Nice to Have:
Experience with syringes or injectable liquids ;
Experience working with CMOs ;
Understanding of fill & finish steps and their impact on the product ;
Ability to translate needs into lab language/protocols ;
Experience writing scientific reports.
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 and maintain automation documentation and software for all assets lifecycle ;
Attend to workshops to ensure alignment with the different companies and disciplines ;
Participate to the overall automation strategy ;
Follow ‘up Automation Integrator and Vendor Packages during development and execution ;
Put in place strong collaboration with manufacturing entities to deliver strong support and expertise ;
Verify Automation Integrators deliverables and anticipate any cost increase ;
Attend to FAT / SAT / commissioning / Validation ;
Ensure automation deliverables follow GMP and HSE regulations ;
Proactively report and manage risks ;
Review verification protocols ;
Be part for 24/7 guard support in hybrid model with Automation Integrators (L1/L2) ;
Organize operator training ;
Perform handover to operation and support team ;
Manage punch list related to its packages / buildings.
Profil
Master's Degree
5 years in Engineering projects in Process Automation
Proven involvement in significant engineering projects, including risk/mitigation management ;
Good level of French and English ;
Strong knowledge of AVEVA System Platform (SP), OMI and RM with hands-on experience in troubleshooting and production support ;
Strong knowledge of SSMS (SQL Server Management Studio) for troubleshooting, running queries to extract and analyze data for investigations ;
Basic knowledge of SSRS (SQL Server Reporting Services) applied to designing, maintaining and troubleshootings generation of reports for operational needs ;
Basic knowledge of Aler AMS application with experience in configuring and monitoring the system for production support ;
Strong knowledge in design, execution and C&V ;
Ability to translate and present expert concerns to facilitate decision ;
Ability to work in highly dynamic environment and to handle challenging situations ;
High communication skills (leadership, negotiation, change management, facilitation) ;
Able to reach team decision and high sense of responsibility ;
Ability to challenge and argument ;
Ready to travel a limited period of time ;
Nice to Have:
IT knowledge (network, PC management) ;
Ability to communicate with IT ;
Pharma experience ;
Awareness of quality/regulatory requirements.
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]
Ondersteunen van de QA Engineering afdeling bij alle Qualification/Validation activiteiten gedurende de volledige levenscyclus van systemen en processen (concept, project, operationeel, retirefase).
Reviewen en goedkeuren van kwalificatie- en validatiedocumenten, SOP’s, user requirements, risicoanalyses, testplannen, test scripts, change controls, CAPA’s, etc., conform cGMP.
Actief deelnemen aan engineering teams en samenwerking met andere groepen bij introductie of upgrade van systemen en processen.
Adviseren en ondersteunen bij voorbereiding en uitvoering van kwalificatie-/validatieactiviteiten en bewaken van cGMP compliance.
Opvolgen en afhandelen van afwijkingen tijdens kwalificatie-/validatieactiviteiten.
Rapporteren van status (kwaliteit, compliance, planning) aan QA Qualification/Validation team.
Profiel
Ervaring in chemische of farmaceutische industrie op het vlak van qualification/validation.
Kennis van cGMP regelgeving en richtlijnen.
Vermogen om technische informatie te vertalen naar begrijpbare informatie voor alle niveaus.
In staat om urgentie, kritischheid en impact van beslissingen correct in te schatten.
Multitasken en werken aan meerdere projecten tegelijkertijd.
Zelfstandig werken én functioneren in cross-functionele teams.
Sterke communicatieve vaardigheden.
Vloeiend in Nederlands en Engels (mondeling en schriftelijk).
Kennis van systemen binnen pharma/chemical sector: Manufacturing, Lab, Building, Utility, IT, Automation.
Ervaring met probleemrapportering, change requests en document management systemen (bv. Trackwise, Comet, TruVault) en test tools zoals Kneat.
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]
Complexe problemen en situaties structureren en stap voor stap en transparant aanpakken.
Proactief communiceren en rapporteren naar stakeholders binnen engineering, productie, STS en externe partijen.
Samenwerken en aligneren met stakeholders tijdens meetings en op de werkvloer.
Flexibel aanpassen aan het takenpakket afhankelijk van de projectfase (documentatie, werfopvolging, machinetesten).
Zelfstandig werken met veel initiatief, assertiviteit en een kritische blik.
Profiel
Master diploma in een technische of wetenschappelijke richting (industrieel ingenieur, burgerlijk ingenieur, bio-ingenieur, …).
Affiniteit met de farmaceutische sector is een must.
Ervaring in een farmaceutische of GMP aseptische omgeving is een groot pluspunt.
Validatie-ervaring is een groot pluspunt.
Ervaring met projectcoördinatie of aannemersbeheer is een pluspunt.
Sterke communicatieve en organisatorische vaardigheden.
Analytisch, punctueel en proactief ingesteld.
Grote interesse in technische, technologische en procesmatige aspecten.
Flexibel en in staat om om te gaan met frequente veranderingen in project/omgeving.
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]
