Laboratory work and writing of methods and protocols.
Use of analytical techniques: chromatography (size exclusion, reverse phase, affinity, ion exchange, HILIC, HIC), capillary electrophoresis (CGE, CzE, iCE, MauriCE).
Collaboration with the team for theoretical and practical training.
Communication with the company contact point, planning, and technical experts.
Development, validation, and transfer of methods.
Design of experiments.
Autonomous management of laboratory activities related to method development, validation, and transfer.
Contribution to release and stability testing according to project needs.
Preparation, review, and approval of documentation (procedures, protocols, reports).
Analysis and verification of results.
Presentation and discussion of results in project team meetings.
Compliance with GMP/HSE rules and regulatory requirements according to product development phases.
Your profile:
3-5 years of experience in the pharmaceutical industry.
Good knowledge of protein chemistry.
Expertise in at least one analytical technique (chromatography or capillary electrophoresis).
Knowledge of Empower software.
Written and spoken French, written English.
Understanding of the principles behind the methods (not just execution).
Expertise in analytical method development and validation.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
Nice to Have:
Experience in biochemistry and separation of biological matrices.
Knowledge of separation techniques applied to proteins.
QC experience with understanding of methods.
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]
Execute technology transfer and upscale projects, in close collaboration with the company cross-functional teams (MSAT, External Manufacturing, Industrial & Analytical Leads, Quality, Regulatory etc.) and CMO.
Depending on the type of project, act as project manager or project team member.
Review and approve all project documentation (protocols, reports, risk assessments, forms,…)
Regularly track the project’s progress (timing, activities, resources, costs) against the plan and adjust as needed
Collaborate with the Quality team to ensure product quality and consistency, and manage deviations and change controls
Ensure manufacturing processes comply with regulatory requirements and industry standards
Edit CPV reports for the company products manufactured at the CMO and tested by the company
Participate in projects (upscale, technology transfer): assist to internal and external meetings, review/approve project documentation, manage deviations and change controls, report project progress internally
Provide the technical expertise to support the company’s CMO to ensure effective processes
Implement project management best practices throughout the project
Your profile:
Master’s degree in engineering, Pharmaceutical Sciences, or a related field.
Minimum of 5 years of experience in pharmaceutical manufacturing processes.
Technical and industrial expertise in sterile pharmaceutical products.
Experience in managing technology transfers.
Experience with compliance in a GMP environment.
Experience in project management
Fluent in French & English (written and spoken)
Subject matter expert in technical / manufacturing aspects related to sterile DP compounding and filling activities
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]
Projectmanagement en overkoepelende end-to-end validatie voor lancering van nieuwe mRNA-producten vanuit een nieuw RNA-platform.
Begeleiden van het volledige traject van concept tot lancering.
Samenwerken met interne en externe afdelingen (Engineering, Productie, R&D, Device Center of Excellence, Verpakking, QA, Procurement, Supply, Quality Projects).
Plannen, coördineren en prioriteiten stellen in een agile omgeving.
Motiveren en ondersteunen van project engineers om deadlines te behalen.
Rapporteren van projectstatus en voortgang in verschillende meetings.
Escaleren van risico’s en oplossen van problemen met verbeteraanbevelingen.
Toezien op naleving van afspraken, procedures en kwaliteitsstandaarden.
Stakeholdermanagement en communicatie op hoog niveau.
Opvolgen en uitvoeren van validatie-activiteiten in brede zin.
Profiel
Grondige kennis van GMP’s.
Kennis van design en productieprocessen van steriele geneesmiddelen.
Sterke affiniteit met end-to-end procesvalidatie.
Ervaring met validatie en procesoptimalisatie.
Ervaring met projectmanagement.
Kennis van onderzoeksmethodologieën voor root cause-analyse.
Sterke analytische vaardigheden en kritische mindset.
Perfecte beheersing van Nederlands en Engels.
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]
Assurer la coordination de la validation de projets majeurs en Drug Substance et Product
Assurer l’approche ‘state of art’ de la Validations du plan de validation (= stratégie de validation) jusqu’au Validation Summary Report, incluant :
Ecriture, revue et approbation de document de validation tels que les Risk Assessments, les protocoles IQ/OQ/PQ, les rapports IQ/OQ/PQ …
Coordination de l’exécution des protocoles
Votre profil?
Expertise en validation IQ/OQ/PQ et GMP
Connaissance en validation de produit injectable.
Solides connaissances en organisation matricielle et en gestion de projet.
Solides compétences en communication, organisation et influence pour travailler de manière transversale.
Parler couramment le français et l’anglais
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu’un package salarial attractif. Vous profiterez également de l’opportunité de vous développer personnellement et professionnellement à travers des formations internes.
Key Responsibilities · Perform upgrades of outdated HMI systems to Siemens TIA Portal · Integrate Simatic Logon functionalities into systems · Convert existing WinCC configurations · Create and maintain validation lifecycle documents according to company and regulatory standards · Conduct testing of shopfloor systems · Assist with and execute validation protocols (IQ/OQ/PQ) · Develop Standard Operating Procedures (SOPs) · Provide support during operations/production startup of automation systems Qualifications · Proven experience with Siemens TIA Portal and Step 7 · Strong knowledge of GAMP5 and the System Validation Lifecycle · Solid understanding of the pharmaceutical industry and applicable standards (GxP, GDP) · Proficiency with Microsoft SQL · Fluent in Dutch and English, both verbal and written · Previous experience with project management in a pharmaceutical engineering environment
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]
External Operations Quality Partner Brabant Wallon – Contracting What are your responsibilities?
Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).
Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects
Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..
Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
Provide support in the evaluation of Temperature excursions for IMP.
Management of Quality Complaints of IMP.
Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
Contribute the preparation of audits (internal/external, regulatory inspections)
Lead internal audits / Self-Inspections
Who are you?
5 years’ experience in QA/compliance experience in pharmaceutical regulated environment
Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
Strong experience in batch review.
Quality mindset with a pragmatic and proactive approach.
Fluent in English is a must and French is a nice to have.
Experience working with CMOs and vendors.
Familiarity with GMP and GDP standards.
Experience with quality systems (deviation management, complaints, change control)
Familiarity with clinical packaging environments (vs. commercial) is a plus
Certified auditor status is a 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 invite you to apply!
Doel van de functie: Als CSV Engineer binnen de ICS Automation afdeling ben je verantwoordelijk voor het waarborgen van de gevalideerde status van computer(systemen) en geautomatiseerd equipment in een hoog gereguleerde farmaceutische omgeving. Je levert ondersteuning en expertise op vlak van validatie, data integriteit en compliance. Daarnaast speel je een coördinerende en adviserende rol binnen diverse automatisatieprojecten.
Jouw verantwoordelijkheden:
Bieden van inhoudelijke ondersteuning en expertise op vlak van software en infrastructuurproblemen.
Adviseren van projectteams op basis van kennis van procedures, compliance vereisten en softwarevalidatie.
Bijdragen aan snelle en efficiënte implementatie van oplossingen.
Coördinatie van validatieactiviteiten binnen automatisatieprojecten.
Bepalen van de juiste validatieaanpak volgens interne procedures.
Opstellen van validatieplannen, -protocollen en -rapporten.
Uitvoeren van risicoanalyses gerelateerd aan computer(systemen).
Coaching en begeleiding van Project Engineers inzake validatieprincipes.
Uitvoeren en opvolgen van periodieke evaluaties (Periodic Reviews) van alle in scope computer(systemen) om continue compliance te garanderen.
Verantwoordelijk voor de opvolging van de Data Integrity status van geautomatiseerd equipment.
Fungeren als aanspreekpunt voor Data Integrity gerelateerde vragen en ondersteuning binnen de site.
Mee bewaken van de DI-vereisten als onderdeel van onze “license to operate”.
Jouw profiel:
Masterdiploma Industrieel, Burgerlijk of Bio-ingenieur met sterke interesse in automatisatie en softwarevalidatie.
Grondige kennis van en/of ervaring met softwarevalidatie, compliance en CSV-processen in een GMP-omgeving.
Vlot kunnen werken met Microsoft Office tools.
Vloeiende kennis van zowel Nederlands als Engels (schriftelijk en mondeling).
Sterk analytisch vermogen en oog voor detail.
Communicatief vaardig en interpersoonlijk sterk.
Organisatorisch sterk, gestructureerd en accuraat in uitvoering.
In staat om strategisch en geduldig te werk te gaan bij complexe site-brede projecten.
Je weet een goede balans te vinden tussen compliance en efficiëntie.
Klantgerichte instelling met de motivatie om processen te optimaliseren in functie van de gebruikersnoden.
Ervaring of uitgesproken interesse in projectmatig werk binnen een productieomgeving.
Ons aanbod? Wij bieden je een contract van onbepaalde duur en een aantrekkelijk salarispakket. Je krijgt bovendien de kans om zich zowel persoonlijk als professioneel te ontwikkelen via interne opleidingen. Geïnteresseerd? Wacht dan niet langer en stuur je CV naar [email protected]
Facilitate interactions between Global sterility assurance and the CMO under its responsibility by establishing working relationship (Service Level agreement using Key Performance Indicators) with the leaders and main contact people.
Act as a main point of contact for the CMO in supporting the implementation of the client Sterility Assurance Strategy
Is the point of contact for supporting the CMO in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road map
Support CMO in the execution of the annual CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects) and perform process confirmations on targeted topics
Partnership with CMO for Key Performance Indicators analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's and QMS, FDA Guidance, etc.)
Review with CMO the annual performance in Sterility Assurance and help on the preparation of the next CCS
Assure availability of Sterility Assurance experts for supporting CMO in a specific domain according to annual CCS priorities.
Accountable for alignment in way of working and standard works between CMO in Sterility Assurance subjects.
Is the Sterility Assurance quality generalist and therefore act as SPOC 9Single Point of Contact) in case of issue/question raised by the CMO.
External advocacy: Lead or influence proactively Sterility assurance external trade associations.
Developing Capability: Supporting the development of sterility assurance capability across key areas of the business through delivery of training, coaching and mentoring.
Why you?
Bachelor degree in a Scientific Discipline
Significant experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files
Strong technical and quality skills in sterility assurance issue
Coaching and mentoring capabilities for shopfloor training and education
Strong verbal and written English language skills & French
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]
Zelfstandig plannen, opvolgen en uitvoeren van validatiestudies.
Ondersteuning bieden aan analisten m.b.t. T&RH-studies in productie en laboratoria.
Opstellen, reviewen en goedkeuren van validatiedocumentatie (protocollen, testscripts en rapporten).
Initiëren en opvolgen van wijzigingen (change control) volgens vastgelegde procedures.
Beheer van afwijkingen en uitvoeren van root cause analyses.
Coördinatie en opvolging van T&RH-projecten (inclusief ownership van systeem, procedures en formulieren).
Implementeren van verbeterprojecten in processen en werkwijzen.
Profiel:
Master diploma in een wetenschappelijke richting (bijv. Bio-ingenieur, Industrieel Ingenieur, Apotheker, Biochemie, Biotechnologie) of gelijkwaardig door ervaring.
Aantoonbare ervaring met cGMP en Right First Time (RFT) principes.
Sterke technische en analytische vaardigheden.
Ervaring met validatie en technische documentatie.
Proactieve teamplayer met goede communicatieve vaardigheden.
Werkt georganiseerd, accuraat en kwaliteitsgericht.
Vloeiende kennis van het Nederlands en Engels (schriftelijk en mondeling).
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]
Déploie efficacement des projets en collaboration avec les différents acteurs en place, en assurant une coordination optimale et une synergie entre les équipes.
Développement de solutions scientifiques pour optimiser les processus
Identifier, analyser et gérer de manière proactive les risques associés au projet.
Organiser et leader le Steering Committees pour le projet, les PRB, les réunions d’alignement.
Développer et promouvoir une vision stratégique claire pour les projets, en tenant compte de l’évolution des besoins de l’entreprise.
Assurer une communication fluide et efficace au sein du projet ainsi qu’avec les stakeholders, en adaptant les messages selon les audiences.
Garantir le suivi des indicateurs de performance du projet et des projets associés
Piloter la gestion du budget du projet, en garantissant un suivi des dépenses et en élaborant des projections pour les années futures
Principaux projets : 1- Projet de validation et qualification d'une nouvelle tour de chromatographie (validation et qualification, implémentation de l'équipement en production) 2- Projet DOE élution allongée (test à petite échelle de l'effet cumulé des élutions allongées QXL HA sur le rendement et l'élimination des impuretés)
Votre profil:
Capacité démontrée à acquérir rapidement des connaissances sur des sujets nouveaux dans un environnement complexe et en constante évolution.
Capacité à faire valoir le positionnement scientifique basé sur des évidences.
Aptitude à s’intégrer facilement dans des équipes pluridisciplinaires et à collaborer avec des parties prenantes variées.
Expérience avérée dans la gestion de projets complexes, avec une expertise particulière dans les domaines du process et de la validation dans l’industrie pharmaceutique.
Proactivité et capacité à anticiper les besoins du projet, en prenant des initiatives pour garantir son succès.
Sens critique et capacité à gérer des priorités multiples dans un environnement dynamique.
Orientation résultats, avec un sens de l’organisation et de la gestion des délais.
Capacité à synthétiser les messages clés pour le management.
Notre offre : Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Nous serons votre partenaire de carrière à chaque étape de votre parcours professionnel. Intéressé(e) par cette opportunité ? Nous vous invitons à postuler ou à m’envoyer directement votre CV à l’adresse suivante : [email protected]
