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]
Location:Brabant Wallon, Région wallonne, Belgique
Job#26711
Microbial Colony Counting and AI Support
Contracting – Brabant Wallon
Your responsibilities: We are seeking a motivated and detail-oriented Contract Worker to support the evaluation and assessment of supplier solutions related to microbial colony counting. This role involves contributing to the testing phase, generating comprehensive reports, supporting the evaluation of AI algorithms, and performing image labeling tasks. The ideal candidate will be a quick learner, able to work collaboratively within a team, and demonstrate autonomy.
Assess and evaluate supplier solutions for microbial colony counting, ensuring accuracy and reliability.
Conduct testing phases and document findings in detailed reports.
Provide support in testing and evaluating AI algorithms for image analysis and related data.
Perform precise image labeling and annotation tasks to support AI-driven solutions.
Collaborate with team members across departments to share insights and ensure alignment of objectives.
Adapt quickly to new tools, technologies, and methodologies essential for the role.
Maintain a high level of autonomy while managing tasks and delivering results within deadlines.
Your profile:
Proficiency in French and English (both written and spoken).
Educational background in life sciences, microbiology, computer science, or a related field (or equivalent experience).
Familiarity with microbial colony counting processes and laboratory testing methods.
Basic understanding of AI algorithms and their applications in image analysis.
Experience with image labeling tools or software is a plus.
Excellent analytical and problem-solving skills.
Ability to work collaboratively within a team while demonstrating independence and initiative.
Adaptability to learn and apply new technologies and methodologies quickly.
Preferred Qualifications:
Previous experience in microbial research or AI-based image analysis projects.
Knowledge of supplier solution assessments or vendor 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]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#26702
Technical Assistant & Project Manager
Contracting – Brabant Wallon
Your responsibilities:
Actively participate in technology transfer and upscaling projects at CMOs.
Represent the company in projects managed by CMOs.
Collaborate with internal teams (quality, technical, regulatory, manufacturing).
Review and approve validation protocols and reports.
Monitor timelines, activities, budgets, and ensure regulatory compliance.
Manage deviations, change control, and CPV (Continued Process Verification).
Provide technical support and critical insight on sterile operations (compounding & filling).
Your profile:
Experience in sterile pharmaceutical environments (syringe/vial filling).
Knowledge of technology transfers.
Project management skills.
Quality mindset (QA).
Fluency in French & English.
Ability to work with external partners (CMOs).
Autonomy, integrity, and influencing skills.
Nice to Have:
Experience in validation, deviation management, CPV.
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]
Data & Process Engineer Contracting – Antwerpen Verantwoordelijkheden
Ontwikkelen van geautomatiseerde scripts in Python, SQL, R, DAX en/of VBA voor dataverzameling, verwerking en analyse.
Opzetten en onderhouden van ETL-processen: datastromen beheren van bron tot analyse met filtering, formatting, compressie en veilige opslag.
Automatiseren van analyses en datacollectie via scheduler-gestuurde scripts (Python, Power Automate, AirFlow, Windows Task Scheduler).
Ontwikkelen van eenvoudige Power Apps ter ondersteuning van productie-, maintenance- of CI-processen.
Bouwen van Power Automate flows voor repetitieve handelingen (alerts, goedkeuringen, automatische updates).
Integreren van databronnen (PI System, SCADA, Oracle SQL, DBeaver, datalakes) in analyses en tools.
Bewaken van GxP-compliance en data-integriteit (ALCOA+), inclusief traceerbaarheid, versiebeheer en audit-trails.
Analyseren van trends in efficiëntie, verbruik, capaciteit, robuustheid en performantie van installaties.
Vergelijken van productiecycli en parameters over verschillende installaties en processen (CIP/SIP, batching, holding, filling).
Vertalen van inzichten naar visualisaties in Power BI, PI Vision en Excel (incl. interactieve filters en slicers).
Ondersteunen van CI-initiatieven en verbeterprojecten met objectieve data en trendanalyses.
Samenwerken met Operations, Support Engineers, CI-teams, Maintenance en Automation en vertalen van inzichten naar concrete acties.
Ondersteunen van root cause analyses (M1/M2) met datagedreven inzichten.
Opbouwen van proceskennis in Preparatie, Formulatie en Filling om datatrends correct te interpreteren.
Delen van expertise, coachen van collega’s en bijdragen aan standaardisatie van tools en analyses.
Profiel
Master in een technische richting (bio-ingenieur, ingenieur, computerwetenschappen, chemie) of gelijkwaardige ervaring.
Ervaring met programmeren/scripting in minstens één taal (Python, R, SQL, VBA).
Sterke analytische vaardigheden met focus op procesoptimalisatie.
Interesse in of ervaring met farmaceutische of voedingsproductieprocessen.
Zelfstandig, nauwkeurig en communicatief sterk.
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]
