Your responsibilities: Commissioning and Qualification: Review IQOQ protocols and reports to ensure the qualification of CPP, support the team for risk analysis creation (SRA), review equivalence certificate, write validation plans…
Validation: According to the client’s standards and procedures, design the validation strategy through PQ protocol redaction, ensure the readiness for PQ validation, coordinate validation (on the floor job expected), manage unplanned events associated with validation, be the contact with QC.
Product validation: Understand the product validation lifecycle and ensure that the validation strategy is in line with the product validation strategy, support the product steward in product related topic (E&L, holding time, …).
Change Control: Assessment of the validation impact through eCC assessment (Stakeholder role expected), Coordinate eCC, and be responsible of eCC tasks.
Project management: Plan and manage PQ activities (material, documentation, people…), support the project planner, animation of meetings/workshops, help the production representative in the understanding of validation requirements.
Your profile:
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy).
At least 5 years’ professional experience in pharmaceutical environment, in quality and validation environment.
Good oral and written communication skills in French & English (for efficient communication with engineering office and suppliers).
Good Knowledge of GMP Regulated environment related to validation activities.
Good interpersonal relationship skills – To be a good team player to success in each validation.
Problem solving and achievement oriented.
Be organized.
Nice to have:
Knowledge of freezer dryers, filling lines and isolators would be an asset.
To maintain and keep up to date its knowledge and experience necessary to the function.
Ability to take decisions in stressful conditions.
Proactive and ready to take the lead to make things happen.
Ability to work under pressure on multiple deliverables within project timelines.
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? I 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]
Heb jij een passie voor techniek en leiderschap en wil je een tastbare impact maken op het eindresultaat van prefab-projecten? Dan is deze job iets voor jou!
Voor onze klant regio Aalter zijn we op zoek naar een Atelierverantwoordelijke. Zin om deze uitdaging aan te gaan via Jefferson Wells? Lees dan alvast onderstaande functie-inhoud!
Jouw verantwoordelijkheden? Als Atelierverantwoordelijke Prefab combineer je jouw technische expertise met leidinggevende capaciteiten, begeleid je jonge collega’s en optimaliseer je processen in het atelier. Jouw takenpakket:
Lezen, controleren en meten van isometrieën.
Beheersen van verschillende lasprocessen en materiaalsoorten.
Opstellen van het plan van aanpak in de prefab, inclusief selectie van spoolstukken, lasproces en lasplan, in overleg met het team.
Meewerken tijdens de opstartfase of drukke momenten in het atelier.
Toezicht houden op veiligheid, kwaliteit van het laswerk, maatvoering en haaksheid.
Bewaken van correct gebruik van machines (zaagmachine, pendelaar, kolomboor, …) en stimuleren van zorgzaam gebruik.
Monitoren rendement van de prefabactiviteiten in samenspraak Project Manager.
Invullen van alle noodzakelijke documenten ter ondersteuning van het prefabproces
Wie ben je? Je beschikt over een technisch diploma en hebt ruime technische kennis op het vlak van lassen, montage en prefab. Je bent een geboren leider en coach, bij voorkeur met ervaring in een technische of industriële omgeving. Je kan werkzaamheden efficiënt plannen, coördineren en monitoren, met oog voor kwaliteit en veiligheid. Daarnaast deel je graag je kennis met jonge collega’s en geef je constructieve feedback.
Wat kan je verwachten? Je komt terecht in een dynamische en innovatieve organisatie waar teamwork, vakmanschap en persoonlijke ontwikkeling centraal staan. De rol biedt een aantrekkelijk loonpakket, inclusief extralegale voordelen en de mogelijkheid tot een bedrijfswagen.
Voldoet deze functie aan jouw verwachtingen of wil je meer informatie? Solliciteer dan rechtstreeks via deze website of contacteer Sara Van den Bossche op het nummer +32 (0)472 79 10 42 of via mail [email protected].
Localisation : Charleroi Mode de travail : 100 % sur site Langue requise : Français uniquement
Contexte
Nous recherchons un(e) Développeur PHP (junior ou medior) pour rejoindre une équipe technique dynamique à Charleroi. Vous travaillerez sur des projets web variés dans un environnement collaboratif, où la proximité et l’échange sont au cœur du quotidien.
Missions
Développement et maintenance d’applications web en PHP
Participation à l’analyse technique des besoins
Implémentation de fonctionnalités côté serveur
Collaboration avec les équipes produit, design et support
Tests, documentation et amélioration continue du code
Veille technologique et proposition de solutions innovantes
Profil recherché
Formation en informatique ou expérience équivalente
Bonne maîtrise de PHP (frameworks comme Laravel, Symfony ou autres sont un plus)
Connaissances en base de données (MySQL, PostgreSQL…)
Capacité à travailler en équipe et à communiquer efficacement
Autonomie, rigueur et esprit d’initiative
Français courant requis (langue de travail)
Expérience professionnelle souhaitée, mais les profils juniors motivés sont les bienvenus
Ce que nous offrons
Un environnement de travail convivial et humain
Des projets concrets avec un impact direct
Une équipe francophone soudée et bienveillante
Des perspectives d’évolution et de montée en compétences
Un poste en présentiel complet, favorisant les échanges et l’apprentissage
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]
Vast Contract of freelance– Regio Oudenburg #bouwkunde #projectingenieur
Dit bedrijf ademt bouw en beton. Met jarenlange ervaring en een stevige reputatie in de sector zijn ze een vaste waarde voor wie kwaliteit en maatwerk zoekt. Als Projectingenieur Beton kom je terecht in een omgeving waar technische kennis en samenwerking centraal staan. Je krijgt de ruimte om te groeien en je ideeën tot leven te brengen, terwijl je samen met een enthousiast team werkt aan uitdagende projecten. Hier bouw je letterlijk en figuurlijk mee aan de toekomst.
Jouw verantwoordelijkheden?
Als Projectingenieur Beton combineer je je bouwkundige kennis met je gevoel voor detail en verantwoordelijkheid.
Je hebt een diploma bouwkunde (industrieel ingenieur of gelijkwaardig door ervaring).
Je analyseert dossiers grondig en vertaalt ze naar concrete plannen en oplossingen.
Je zorgt dat de modellering van betonelementen correct en volledig gebeurt.
Je werkt georganiseerd, houdt overzicht en grijpt in waar nodig.
Je bent communicatief sterk en bouwt een goede samenwerking op met klanten, leveranciers en collega’s.
Je houdt van teamwork en herkent jezelf in een gedreven en positieve mentaliteit.
Wie ben je?
Ben je iemand met bouwkundig inzicht, oog voor detail en een stevige dosis verantwoordelijkheidsgevoel? Dan sluit jouw profiel mooi aan bij de rol van Projectingenieur Beton. Zowel starters als kandidaten met ervaring komen in aanmerking. Je bent computervaardig, hebt zin om met 3D-tekenen aan de slag te gaan en leert Tekla graag beter kennen. Je houdt ervan structuur te brengen in je werk, bent communicatief sterk en werkt graag samen met anderen. Herken jij jezelf in deze mix van talenten en drive? Dan willen we jou zeker ontmoeten.
Wat kan je verwachten?
Wie kiest voor de functie van Projectingenieur Beton krijgt meer dan alleen een baan. Je mag rekenen op een aantrekkelijk loonpakket met maaltijd- en ecocheques, verzekeringen en zelfs de mogelijkheid op een wagen. Daarbovenop geniet je van flexibele werkuren, extra ADV-dagen, en de optie om af en toe thuis te werken. Je wordt deel van een jong en hecht team dat elkaar ondersteunt en vooruithelpt. En het mooiste? Je krijgt de kans om jezelf verder te ontwikkelen en door te groeien binnen een stabiel en mensgericht bedrijf.
Ook freelancers komen in aanmerking!
Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Jens Blanchet op het nummer +32 (0)4 79 43 32 62 of via jens.blanchet(@)jeffersonwells.be.
