To support activities for defining and selecting drug product manufacturing processes and components for clinical manufacture
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 (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc)
Capture and analyse 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 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
Your profile:
Bachelor’s degree in Sciences
Minimum 2-3 years’ experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required.
Experience within the biopharmaceutical industry is an advantage
Knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) is an advantage
Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimization is an advantage.
Scientist grade
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]
Ingénieur en automatisme et Amélioration Process – Chimie minérale Contracting – Marche-en-Famenne
Votre mission
Prendre en charge, gérer et coordonner des études d’amélioration, de procédés de fabrication existants.
Prendre en charge le déploiement de la politique digitale au sein du site.
Les études d’amélioration et de fiabilisation du Process de fabrication et de la logistique
Les tâches liées au déploiement de la Digitalisation des procédés au travers de la création et/ou de l’informatisation des rapports nécessaires à la bonne gestion du secteur concerné.
Etude et mise en place des actions visant a uniformiser la politique de digitalisation en cohérence avec l’ERP en place.
Fiabilisation Process :
Etudier et préparer les projets d’amélioration Process sur les secteurs de la fabrication et logistique.
Traduire l’idée (conception) en réalisation et digitalisation de la démarche.
Suivre les projets et être présent sur le terrain jusqu’à leur réalisation.
Digitalisation :
Transformer les rapports papiers de tous les secteurs en données informatisées.
Privilégier la capture des datas automatiquement à la source.
S’assurer d’éliminer les doubles encodages.
Créer le lien avec l’ERP ( SAP B.one)
Votre profil
Formation : Bachelier / ingénieur industriel en chimie
Expérience en conduite d’un outil de production en chimie industrielle, verrerie, pâte et papier, extraction/raffinage de minerais, métallurgique primaire, de produits métallurgiques finis, bureaux d’ingénierie, …
Expérience : dans un poste de fabrication si possible en industrie lourde
Notre offre Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Vous aurez accès à des formations techniques et en compétences comportementales (soft skills). 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]
Ensure the organization, maintenance and lifecycle management of controlled documents and training materials
Ensure compliance with applicable regulatory frameworks (GLP, GCP, Research Guidance, HTA, HBS, HSE, etc.) and internal standards
Process harmonization and continuous improvement
Support the design and implementation of streamlined, harmonized processes that integrate documentation and learning activities
Contribute to continuous improvement initiatives aimed at enhancing efficiency, simplification, compliance and user experience
Promote best practices and innovative solutions in documentation and learning management, fostering a harmonized, customer-focused, and outcome-driven culture
Act as the coordinator for the Regulated/Non-Regulated/Controlled Document management system, ensuring timely tracking, updates, reviews, and approvals of SOPs, guidance and related documents (based on regulatory changes, SME inputs, inspection finding or scheduled reviews)
Provide expert guidance to document owners and Patient Solutions staff on controlled document management best practices.
Ensure effective training and communication related to new or revised SOPs & associated documents, including timely withdrawal of obsolete documents
Training coordination
Support Patient Solutions employees and managers in meeting training requirements by maintaining accurate training plans, curricula and matrices
Ensure the availability and accessibility of training materials linked to controlled documents impacting Patient Solutions
Collaborate with the department learning lead and line managers to develop and maintain relevant training programs (plans, matrices, …).
Manage training records and documentation, including CVs, job descriptions, attendance logs, training registers, ….
Stakeholder engagement and support:
Serve as a key point of contact for all Learning & Documentation-related questions.
Manage and respond to requests received, including through the global PSol Learning & Documentation mailbox.
Audit & Inspection Readiness
Ensure operational readiness for internal and external inspections and audits related to documentation and learning.
Track and follow up on actions resulting from audit or inspection findings.
Performance Monitoring & Reporting
Collect, consolidate, and report key performance indicators and metrics related to documentation and training compliance.
Maintain and update the Learning & Documentation compliance dashboard.
Additional operational support
Provide support as needed to the Head of Internal Coordination, Learning & Sustainability Compliance in managing and reporting on broader initiatives, including sustainability, compliance, communication, intranet content, PMO dashboards, and objective tracking
Who are you?
Relevant experience in GxP (GLP, GCP) regulations and within the pharmaceutical industry
Relevant experience in SOP /training and content management systems
Familiar with electronic document management systems (e.g., Veeva, SharePoint, or similar platforms) and Learning Management Systems (LMS) for training assignment, tracking, and reporting.
Languages skills: French and English
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
Ability to collect, analyze, and develop visual reports, KPIs and compliance metrics.
Experience in dashboard creation and, potentially, in the use of communication tools
Detail-oriented with the ability to maintain a high-level perspective
Strong organizational, planning and coordination skills, with the ability to prioritize tasks, manage multiple responsibilities, and proactively adapt in an evolving environment
Ability to interact and collaborate with cross-functional teams and various stakeholders
Analytical mind, ability to make improvement suggestions and resolving issues
Project management and influencing skills
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.
Technicien de Laboratoire Contracting – Marche-en-Famenne
Votre mission En tant que Technicien·ne de laboratoire Contrôle Qualité, vous jouerez un rôle clé dans l’évaluation de la qualité des matières premières, des produits intermédiaires et des produits finis via des analyses physico-chimiques complexes. Vous contribuerez à la gestion quotidienne du laboratoire et à l’amélioration continue des systèmes qualité.
Réaliser les tests de contrôle qualité sur les matières premières, les produits en cours de fabrication et les produits finis
Effectuer les prélèvements et exécuter les analyses selon les procédures GMP et internes
Participer à la gestion générale du laboratoire et collaborer avec les équipes transverses
Encoder et vérifier les données dans les systèmes électroniques, en assurant la traçabilité
Réaliser certaines analyses directement en environnement de production ou salle de contrôle
Identifier les anomalies ou écarts et proposer des actions correctives appropriées
Contribuer à l’entretien du laboratoire : gestion des stocks, calibration des équipements, nettoyage, documentation
Participer aux initiatives d’amélioration continue et respecter les règles de sécurité en vigueur
Votre profil
Diplôme en chimie (niveau A1 ou A2)
Première expérience en laboratoire QC, idéalement dans un environnement GMP
Bonne capacité d’organisation et gestion de tâches multiples
Maîtrise des outils informatiques de base (suite Office) ; la connaissance de l’anglais est un atout
Rigoureux·se, autonome, polyvalent·e et capable de s’adapter à un environnement dynamique
Esprit d’équipe, bonnes compétences en communication et en résolution de problèmes
Notre offre Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Vous aurez accès à des formations techniques et en compétences comportementales (soft skills). 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]
Our partner is currently looking for a Process Tech Transfer Engineer. Our partner is an international pharmaceutical company.
What are your responsibilities? Process Tech Transfer for mammalian biotechnological manufacturing processes:
Support process technology transfers between commercial plants, and support process validations in new plants.
Support process technology transfers from Development to Internal Manufacturing & CMOs and support commercial-scale process validation.
Support the technology transfer activities in terms of:
Definition of the Tech Transfer and process control strategy in collaboration with sending unit,Quality Assurance, Industrial Leads and other identified stakeholders,
Writing risk assessments, protocols, change controls, Tech Transfer reports, as well as technical reports for the execution of Tech Transfer runs for new processes,
Coordination of sampling and analyses with the manufacturing teams, as well as external laboratories, sending unit and Analytical Transfer & QC Readiness team.
Ensuring adherence to project planning.
Support the MSAT Bio Process Heads for tasks such as:
Review of documentation in Source CD,
Preparation and carry-out of Health Authority (HA) inspections.
Validation & Continued Process Verification (CPV) of mammalian biotechnological manufacturing processes :
Support process validation activities, including the definition of the validation strategy:
Drive and write risk assessments and change controls for current and new processes as a manufacturing process expert,
Write validation plans, protocols and reports in adherence with planning,
Ensure adherence of the process validation activities to the applicable documents (VMP, procedures, guidelines, etc.).
Support and ensure the implementation of CPV for new processes
Definition of the initial CPV plan, creation of the initial CPV report,
Creation of the routine CPV plan and participation to the routine CPV committees as SME for
the CPV requirements and methodology,
Implementation of process data trending,
Handover to the manufacturing teams,
Lead complex CPV investigations.
Support and coordinate the CPV activities for UCB on behalf of CMOs/partners.
Operational Support for mammalian biotechnological manufacturing processes:
Provide routine support for manufacturing campaigns, CPV, process and equipment performance trending, new equipment or raw material qualification, first-line troubleshooting and second-line troubleshooting for CMOs.
Support periodic reviews and Health Authority (HA) inspections,
Support filings of Prior Approval Supplement (PAS) submissions.
Process improvement & COGS reduction for mammalian biotechnological manufacturing processes:
Participate in the continuous improvement of Tech Transfer, process validation & CPV documentation and processes, including writing and coordination of Change Controls.
Monitor commercial manufacturing and identify improvement opportunities within the limits of the approved parameters.
Coordinate testing at small scale, validate, and implement process improvements within the limits of approved parameters, including review of protocols and reports for small-scale studies.
Liaise with development teams to provide feedback on platform process performance and/or request 2nd gen. process development.
Participate to deviations and Change Controls as SME for Tech Transfer/validation/CPV-related subjects and provide process expertise where needed.
Participate as SME in technical or organizational cross-functional projects, as well as in specific manufacturing projects for activities related to process Tech Transfer, validation and CPV.
Collaborate with the MSAT Lab team during complex process-related deviations and investigations.
Collaborate with the MSAT Process Leads during projects.
Support improvement projects within the group.
Quality:
Work according to cGMP requirements.
Perform all trainings in the defined deadlines, in order to ensure continued and complete state of training for Tech Transfer/validation/CPV activities.
Use and ensure the use of authorized documents for all activities.
Ensure that all validation/CPV/verification documentation (reports, sops…) is up-to-date and inspection ready.
Present the validation/CPV/verification documentation during inspections and audits by partners and Health Authorities (HA).
HSE:
Actively take part in the application of the HSE policy (Health, Safety and Environment): respect of HSE rules (procedures, wear of Individual Protection Equipment, systematic use of safety elements).
Signal events (incidents and accidents) linked to HSE,
Promote HSE processes within the team and to colleagues from other groups.
To contribute significantly to the construction of a responsible business approach that takes sustainability into
account at all levels (environmental/economic/societal), I am committed to integrating UCB's ambitions for:
Diversity, equity and inclusion,
Business health management (physical, social and mental health),
Environmental policy,
Ethics and Compliance,
Patient Value Added Culture (PVS),
Expected Behavior of Leaders.
Who are you?
Master’s degree in biology, biotechnology or other lifesciences-related field
Strong leadership skills,
High level of spoken and written French and English,
High understanding of biotechnological manufacturing processes,
Good level of proficiency with MSOffice tools,
Basic knowledge of statistics,
Excellent communication skills, for communicating with internal and external partners,
Ability to scope, research and understand complex subjects related to biotech manufacturing,
Ability to structure ideas quickly and clearly,
Excellent organization and problem-solving skills,
Ability to define objectives and how to reach them,
High capacity to anticipate issues, identify priorities and make decisions,
High level of autonomy and good stress management skills,
Solution-oriented and sensitive to customer needs,
Pragmatic and critical-minded,
Sense of responsibility and ownership,
Sense of initiative,
Team player.
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.
Our partner is currently looking for a CMC Product Portfolio Manager. Our partner is an international pharmaceutical company.
What are your responsibilities?
Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.
Who are you?
Minimum 5 years of project, program and/or portfolio management experience and in associated tools
Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
Languages: English is a strong asset and good basis (spoken and written) in French
Ability to work in cross-functional teams, including remotely
You are structured, with excellent organization skills
Robust knowledge of change management
A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
Good communicator and listener in an international environment, you like to communicate complex data in a simple consolidated way
You are agile to gain commitment, proactive, accountable, quality-focused, resilient, with a positive mindset
Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset.
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.
Lab Operations Project Engineer Contracting – Anvers Your Responsibilities:
Act as the main point of contact for lab support during the rollout of a new digital tool, troubleshooting issues related to both existing and to-be-digitized methods
Provide operational support on analytical method validation, lab equipment validation, cleaning validation methodology, performance parameters, and calibration/maintenance of lab devices
If changes to methods or equipment are required, ensure full delivery: draft documentation in line with internal procedures and coordinate practical execution by analysts
Support deviations related to your technical domain and project scope
When necessary, execute analytical tests or validation/installation tests in compliance with cGMP and internal standards
Own the end-to-end responsibility for your project scope, including resource and equipment budget estimation
Remain the key point of contact for follow-up or aftercare once the project is delivered
Lead analysts assigned to your (sub)projects and ensure reliability of analytical results
Serve as the liaison for your project scope within and outside the lab (e.g., other departments, external contractors, or international sites)
Represent your project in cross-functional or corporate teams where applicable
Ensure clear, structured, and regular communication with your team, lab center, management, and clients, including updates on progress, risks, and successes
Escalate milestone risks in a timely manner
Drive productivity, avoid unnecessary costs, and plan for on-time implementation
Your Profile:
Scientific or engineering background with solid experience in a GMP lab environment
Proven experience in analytical method validation, equipment validation, and project coordination
Knowledge of analytical techniques used in cleaning validation and method performance evaluation
Strong documentation skills aligned with regulatory and internal quality standards
Experience leading lab analysts and managing stakeholder communication
Familiar with cGMP guidelines and quality documentation processes
Excellent organizational, planning, and problem-solving skills
Fluent in Dutch and English, written and spoken
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]
Support à la Personne Qualifiée dans le cadre de l’activité de libération des produits pharmaceutiques (ex : Gestion des BMR (Batch Manufacturing Report), des BPR (batch packaging report) des Certificats d’analyse et certificats de conformité, préparation de la documentation relative au contrôle packaging.
Support au Pharmacien Responsable dans le cadre de la réception et distribution des médicaments.
Rédaction des rapports de température lors de la réception des conteneurs et lors de l’envoi de conteneurs
Support au département qualité dans la gestion du système de qualité (QMS) (gestion des documents papiers et informatiques)
Participe aux activités de routine et à l’amélioration continu du département QA
Assure un contact et un suivi avec les différents fournisseurs.
Assister dans les différents projets de développement de la société.
Votre profil?
Connaissance de l’environnement pharmaceutique et de sa réglementation et des guidances spécifiques (GMP, GDP …)
Une expérience dans un département qualité.
2 ans d’expérience dans un environnement pharmaceutique industrie
Maitrise du français et de l’anglais au quotidien
Maitrise des outils informatique (Word, Excel, Outlook)
Avoir un esprit critique et analytique
Excellent relationnel pouvant s’adapter à différentes cultures au niveau des affaires
Vous êtes une personne rigoureuse et méthodique
Vous avez le sens de l’ordre et de l’organisation
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. Intéressé(e) ? N’attendez plus !
Process Engineer Brabant Walloon – contracting Our partner is looking for a Process Engineer to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities? In coordination with Engineering Office and Project Management, you will provide expertise in the implementation of good engineering & design practices and solutions to support design, execution and commissioning / qualification phases of CapEx Projects. You will ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities’ requirement of Secondary equipment’s and Aseptic technologies package. Related to these packages, it includes:
Being the internal representative for all Secondary equipment’s and Aseptic technologies-related activities and installations
Supporting the E.O in management of activities related to this package
Ensuring alignment between E.O and the company Specification and Guidance
Reviewing design and technical documentation
Following-up construction & all testing activities falling under the package’ scope
Ensure systems start-up and punch list solving
Writing and executing commissioning and qualification protocols/reports
Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
Facilitating handover process towards the end user
Your profile?
Engineering degree with 7 years’ experience as Process Engineer in Secondary Equipment’s and Aseptic Technologies domains.
Strong Experience in the Pharmaceutical industry and cGMP environment.
Definition of functional, technical and quality requirements.
Realization of reviews of process studies, P&ID’s and layout.
Oversight contractor’s performance.
Integration of operability and EHS requirements at all design steps.
Preparation of the project testing, commissioning and inspection requirements
Organize legal conformity visits
On-site verification of execution according to good practices
Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…)
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. Do you have any questions? You can contact Anaïs Malikian, [email protected]
Be accountable for technical management including risk management, deviation ownership, change control authoring and coordinating, Product Technical Specification (PTS) and Method of Production (MOP) review and knowledge management. Participate to CC Implementation committee.
Review and approve demand versus supply, assess the capacity available, identify potential risks to service and identify requirements to capacity adjustments to meet future volume projections. Give, understand and master the inputs/outputs of SRM meeting.
Ensure visibility is given on demand and supply information across the supply chain to ensure pro-active management and avoid out of stocks, performance management through set-up, measurement, monitoring and reporting of KPI’s
Drive continuous improvement projects with his/her CMO and with internal and external stakeholders in order to strengthen the CMO operational activities. Support continuous improvement for complex/transversal projects.
Give support to the QA team to ensure compliance of the ES operations with cGMP and Authorities requirements.
Timely escalate issues to Manager if required by internal process
Be accountable for reporting (KPI, monthly)
Be the back up of the SRM (Supplier Relationship Manager
Who are you ?
Experience (preferable 1-3 years) in the following :
(Bio)pharma & cGMP
Quality
Project management
Bilingual French/English (oral & written)
Proactive with ability to identify and follow up on gaps in process
Ability to work under pressure due to the requested flexibility and reactivity of the activities
Be able to manage short term issues with long term activities in parallel.
Ability to work in project teams in a multidisciplinary environment and a matrixial organization
Be able to lead and manage cross-functional projects
Excellent communication and negotiation skillsOur 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.
