Job Location : BRAINE-L'ALLEUD

• Location: Braine-l'Alleud
• Job #25179

Engineering Lead Coordinator

Contracting – Braine l’Alleud

The Responsibilities

• To evaluate the feasibility and risk associated with Capital Investment (CAPEX) projects.
• To relay customer consideration and take benefit of his expertise in the definition of requirement (URS) and the solution design.
• To ensure the management of the supplier until the FAT, SAT and commissioning.
• To support the qualification according to company SOPs and ICH guidance.
• When applicable to organize the process technical transfer.
• This includes:

• To elaborate the technical transfer strategy and to prepare/review of the test protocols. The input should be based on the coordinator’s technical background and the knowledge of the equipment to define a plan technically feasible and acceptable on GMP aspect.
• To coordinate support departments (RA, QC, QA, Qualification/Validation, Development, Technical Services, Industrial IT, Supply Chain, HSE, Metrology, Sourcing, Facility, Finance, Utilities…) for projects implementation.
• To prepare the equipment and to program the recipes on manufacturing equipment.
• To ensure that the equipment runs properly and if needed to connect with supporting services (maintenance, IT and external supplier/service providers).

• To deliver to the client the technological know-how capitalized during commissioning and qualification campaign.
• To support the client department for pre-approval inspections of delivered new equipment and processes.
• To identify, propose and implement technical solutions to improve plant capacities, to reduce COGS, to increase efficiency and improve Quality compliance.
• To supervise the strict application of Safety & Hygiene rules and foster development of improved practices.

Skills and Knowledge Requirements

• Knowhow in automation, packaging, and medical devices technologies
• Senior experience on Project management methodology.
• Prioritization skills and ability to successfully manage multiple tasks simultaneously.
• Teamwork: ability to work well in highly cross functional and inter-site team environment.
• Communication skills: ability to express clearly and concisely within a team. To adjust communication style for the audience. To timely and effectively communicate on issues.
• Technical writing skills to support authorship of internal documentation.
• Knowledge sharing: ability to capture and to digest information from multiple sources and to build intelligible knowledge to be shared with project clients.
• Knowledge of GMPs

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 Aylin Ugurlu at [email protected]

• Location: Braine-l'Alleud
• Job #25162

Non-Clinical formulation Scientist
Contracting – Braine l’Alleud

The Responsibilities

• Manages Non-clinical formulation activities related to the screening and CMC development of small molecule, peptide or other synthetic drug products (from discovery and preclinical stages to clinical formulation orientation work for First-In-Human). Typical formulations are microsuspensions, amorphous solid dispersions, and nanosuspensions.
• Liaises with Non-Clinical formulation Leads to assure consistency between the development and the production of NCL formulation, and the project needs.
• Manages protocols of development or production and participate to the planning of activities.
• Participates to the development, characterization, and production of non-clinical formulations.
• Performs the physico-chemical characterization and stability studies of new molecules (NCEs) on batches before the GLP batch. Typical characterization techniques are liquid chromatography (UPLC), thermal analysis (DSC, TGA), laser diffraction granulometry, optical and electron microscopy. Develops if needed new methods.
• Analyses results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
• Documents and verifies in an appropriate manner the whole of the performed activities (e.g. Electronical Lab Notebook)
• Consolidates the results and write adequate reports.
• Contributes to the writing of technical documents like SOPs, user guides, guidances, etc.
• Participates to the advancement of the department’s Science & Technology and Innovation projects The scientist needs to be autonomous and think pro-actively, in collaboration with the Non-Clinical formulation lead. The need to already have an experience in formulation with a preference for Non-Clinical formulation development, with knowledge in the related analytical support. He needs to be flexible, well-organized, curious and have good communication and coaching skills. He needs to be able to combine multiple tasks and must adapt to priority changes.

Skills and Knowledge Requirements

• Master/PhD: pharmaceutical sciences, formulation, analytical chemistry or equivalent
• Min years’ experience required: 2-3 years in formulation domain, preferentially in non-clinical formulation field.
• Key technical backgrounds: non-clinical formulation preparation, small molecule chromatography (HPLC/UHPLC)
• Mandatory skills: team player, communicative, experience in a similar position/environment, compliant/rigorous, flexible, curious

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.
 

• Location: Braine-l'Alleud
• Job #25146

Analytical Development Analyst
Contracting – Walloon Brabant

Your responsibilities ?
Operational :

• Develop and validate analytical methods to support projects in development in different phases of product development.
• Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in accordance with work instructions and established procedures (stabilities, in-process control, clinical release, investigation, …).
• Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in support to process understanding (IPC test, forced degradation study, multimedia dissolution, …)
• Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
• Participate to analytical exercise transfer to QC and subcontractors.
• Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, …).

Quality :

• Make sure to have received and understood all the information and instructions required for the tasks before starting work.
• Respects the procedures and reports any discrepancies to the responsible
• Use authorized and validated methods prior to testing, if applicable.
• Respect and properly maintain the analytical equipment and facilities at disposal.
• Performs double check the team

Your profile ?

• Master or Bachelor: analytical chemistry

• Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), USP/EP Pharmacopoeias
• Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous (understands the importance of following procedures in 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. Do you have any questions? You can contact Caroline, [email protected]

 

• Location: Braine-l'Alleud
• Job #25118

Material Documentation Specialist

Ce poste fait partie de l'équipe Supply et logistique. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP. La principale responsabilité sera la gestion des Specification et des Change Notification pour les produits biologiques et les thérapies géniques.

Responsabilités

• Assurer la création et la mise à jour des spécifications / FIP et des documents associés (TSE/BSE, Certificats…) pour les matériaux et consommables utilisés en collaboration avec les laboratoires et les ingénieurs process.
• Évaluer/documenter les Change Notification de la Pharmacopée ayant un impact potentiel sur les produits utilisés et mettre en œuvre des actions si nécessaire.
• Gérer l’évaluation des notifications de changements des fournisseurs pour les matières premières et définir des actions associées.
• Participer activement au système de gestion des déviations (ouverture de PR, investigations, CAPA, Change control…) et s’assurer de leur réalisation en temps et en heure
• Gestion logistique des vêtements nécessaire au bon déroulement des activités GMP et le suivi du fournisseur associé
• Participer aux activités de sécurité

Connaissances et Expériences Requises

• Esprit organisé et systématique
• Excellentes compétences en communication, dans la mesure où vous interagissez avec différentes équipes/parties prenantes : opérateurs, responsables de la production, équipe de validation, QA.
• Esprit d'amélioration continue.
• Maîtrise du français et bonne connaissance de l'anglais

Notre Offre
Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
 

• Location: Braine-l'Alleud
• Job #25084

Raw material scientist
Role Summary
The Raw Material Scientist is a technical expert responsible for establishing and coordinating a comprehensive strategy to identify critical/key raw materials during development to support process development decision making.
They will support the definition of appropriate technical controls and the implementation these practices during the development of biologics and gene therapy products to improve process robustness, cost efficiency, and readiness for regulatory submissions.
Key Accountabilities

• Generate risk assessments strategy for current raw materials and identify critical and key ones from a process and supply point of view.
• Support the QbD initiative on raw material and GRAM exercise (CMA KMA definition, generate guideline and templates).
• Define based on risk assessment mitigations and controls to be implemented in collaboration with appropriate teams (in production, release at supplier, shipment, storage, during usage).
• Support the design supportive studies required.
• Support the introduction of new raw materials in close collaboration with process teams (supplier selection criteria at early stage, IPC/specifications definitions, shelf life definitions,  ..)
• Improve raw materials usage in collaboration with process development and clinical manufacturing.
• Create and lead satellite communities per expertise to facilitate exchanges, identify gaps and mitigations, build strategies on lessons learnt and successes to prepare future.
• Author & review technical documents including CMC regulatory sections, SOPs, technical position papers, & technical reports.
• Accumulate knowledge based on lessons learnt, investigation and literature on potential risks, quality and regulatory requirements and suggest alternatives.
• Collaborates with internal and external partners to stay abreast of industry trends and emerging risks related to raw materials, regulatory and quality requirements evolution, best practices.
• As a member of the DSPS team, the raw material scientist may work transversally across projects and groups in line with the needs of the business and as part of the CMC Development Sciences organization.

Critical Competencies & Experiences Required

• At the very least 2 years of experience in CMC development within the biopharmaceutical industry.
• Demonstrated ability to successfully co-ordinate project activities and manage meetings.
• Good interpersonal skills in order to communicate with and maintain fruitful working relationships with colleagues across departments and geographies, as well as external partners.
• Basic knowledge of regulatory guidelines, safety, and quality requirements for raw materials.
• Ability to learn proactively.

Our offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]

 

• Location: Braine-l'Alleud
• Job #24921

Data Integrity and Quality Culture Specialist
Contracting – Walloon Brabant
Your responsibilities?
As Data Integrity and Quality Culture Specialist, you will be our local expert for Data Integrity and Quality Culture. 
You will

• Lead the implementation of the data integrity culture and strategy for our site and ensure compliance with global and local regulatory requirements and customer expectations at the system level
• Ensure that best practices are in place and in use, seek for continuous improvement, while ensuring application of the right level (risk-based approach) of quality
• Assure capabilities buildup within the site through effective coaching, monitoring/reporting, and performance management.

Your Major accountabilities will be:

• Definition and follow-up of data integrity & Quality Culture roadmap for the company. To evaluate and lead continuous improvement initiatives (i.e. Site Quality Plan) concerning data integrity & quality culture, to ensure compliance with quality systems, global requirements, regulations, guidelines and customer requirements.
• Developing and maintaining the Quality Management System in relation to data integrity & quality culture: evaluate the performance management of data integrity, make results visible through KPIs and periodic reports.
• To manage the creation, review, maintenance and delivery of Data Integrity & Quality Culture training material, including but not limited to data integrity onboarding, refresh trainings and excel spreadsheet validation trainings. Train and mentor on the job personnel on data integrity & quality culture aspects from onboarding to increased maturity.
• Participate as data integrity & quality culture Subject Matter Expert in deviation investigations applying RCA tools. Propose and implement associated CAPA / improvement actions concerning data integrity & quality culture. Train and coach deviation investigators on the use of Data Integrity RCA tools and investigating human errors.
• To review and maintain documents related to quality culture and data integrity in accordance with current quality system requirements, regulations, guidelines, and customer expectations.
• Establishment and leading an internal site network of DI champions and actively participating in creation of global multi-site DI community of practice within the company group. Be the point of contact for the site within group.
• To perform Data Integrity internal audits and act as an SME during internal and external audits and inspection for Data Integrity & Quality Culture topics, redacting responses and managing the associated follow-up actions.

Your profile?

• Bachelor or Master’s Degree in Biology, Biomedical Sciences, Pharmacist, Bioenginneer or similar
• Proven experience (at least 3 years)in Quality Assurance or related areas in a GMP environment, including a position of authority in decision making and management of documentation and / or IT.
• Experience in leading training programs and projects in a GMP environment is preferred
• Basic knowledge in multiple quality processes and interfaces with multiple functional areas
• Knowledge of Good Manufacturing Practices standards, local and international regulatory requirements with regards to data integrity & quality culture
• Knowledge of Documentation and Electronic Systems that generate and manage GxP processes and Computer System Validation
• Excellent team spirit and communication skills
• Very good knowledge of French 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.

• Location: Braine-l'Alleud
• Job #24919

Quality Assurance Customers Specialist

Your responsibilities?

Operations:

• Organize, manage and participate in QA activities from early-phase to commercial manufacturing of customer specific APIs, including:
  • Review and approval of the documentation linked to quality agreements, process and analytical optimization & validation, manufacturing operations and stability to comply with the cGMP or other legislation, with the internal Quality System and customer requirements
  • Management and approval of change controls, CAPAs & deviations, OOS and participation in on-line problem solving with other departments
  • Writing of Process validation master documentation and Product Quality Review
  • Release of API batches in close collaboration with QA shopfloor team

• Work in a GMP and Quality environment
• Recommend changes in practices to enhance the conformance to GMP within all departments
• Perform internal and external audits as required
• In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations.

Information/Communication:

• Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls)
• Inform management in case of any major quality or people management problem
• Make personnel aware of the importance of safety, environmental and GMP issues

Your profile?

• Education in Sciences with minimum 3 years-experience in QA in a GMP Environment
• Experiment in customer complaints management
• Fluency in French and English is mandatory (spoken and written English)
• Excellent command of Microsoft office software’s
• High organizational and communication skills, good interpersonal skills, flexibility in tasks and schedules
• Sense of responsibility, enthusiasm, diplomacy and team spirit

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. 
 

• Location: Braine-l'Alleud
• Job #24893

CSV Engineer
Contracting – Braine L’Alleud

Les Responsabilités
– Définir et assurer le suivi des stratégies de qualification CSV qui touchent au projet OMP
– Identifier l’approche d’implémentation de ces stratégies (Change Control, autres)
– Déterminer les impacts validation sur base des release notes du fournisseur
– Évaluer la compatibilité avec les logiciels / micrologiciels existants
– Comprendre, appliquer et communiquer sur les prérequis de validation
– Identifier et contrôler les risques inhérents au projet
– Rédiger les documents de qualification conformément aux SOP
– Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet
– Exécuter et/ou vérifier les tests de qualification des installations en impliquant les futurs utilisateurs et/ou le fournisseur et conformément aux procédures en vigueur
– Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation ou le déroulement de la mission
– Supporter ou prendre à charge des activités liées à de l’amélioration continue
– Assurer le respect de la législation et des normes en vigueur ainsi que des règles de sécurité interne.
Cette liste est non-exhaustive et sera amenée à évoluer en fonction de l’avancement du projet. Par ailleurs, la personne pourra compléter des périodes plus calmes par la gestion des activités de qualification/validation CSV liés au projet automation en cours (autre que ceux d’OMP), soit
: o Définir et assurer le suivi des stratégies de qualification/validation CSV.
o Evaluer l’impact qualification inhérent au risques identifiés.
o Rédiger les documents de qualification conformément aux SOP de qualification / validation.
o Identifier l’approche d’implémentation de ces stratégies (Change Control, autres).
o Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet.
o Exécuter et/ou vérifier les tests de qualification / validation des installations en impliquant les futurs utilisateurs et conformément aux procédures en vigueur.
o Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation des dits projets éventuels.
o Donner le support CSV aux activités du département Site Process Validation (gestion de déviations, CAPA, préparation et/ou participation aux audits, …).
o Mettre à profit son expertise CSV afin de répondre à des sujets spécifiques (position papers, analyses de risque, …) En fonction des priorités des projets et de l’évolution de ceux-ci, la charge de travail pourra évoluer.

Expertise et Connaissances Requises
– Bachelor / Master de préférence à orientation informatique/automation industrielle et autrement, dans un domaine scientifique.
– Au minimum 05 ans d’expérience dans le domaine de la validation dont au moins 03 ans sur les systèmes automatisés et/ou informatisés et en particulier sur des mises à jour / upgrade / revamping de software / firmware.
– Compréhension des flux, des pratiques, des méthodologies et des délivrables de validation.
– Connaissance confirmée de la partie automation des procédés industriels pharmaceutiques (laveuses, testeurs de gants, RABS, isolateur, sertisseuse, remplisseuse, scelleuse, tunnel de dépyro, autoclave, testeurs de filtres, stations CIP/SIP, centrales d’acquisition comprimeuse, mélangeur, système d’inspection visuel, système de sérialisation).
– Connaissance confirmée de la partie équipements de laboratoire (RMN, électrophorèses, spectro UV Vis, Spectro FTIR, qPCR, MALDI TOF etc.).
– Connaissances des paramètres et éléments de conception pouvant avoir un impact qualité sur les procédés susmentionnés.
– Connaissance des techniques en IT/Computer System Validation. – Compréhension et facilité d’expression en anglais.
– Capacité à prendre des responsabilités et des décisions.
– Capacité à entretenir de bonnes relations avec les acteurs du projet.
– Capacité de persuasion et compétence d’assertivité.
– Rechercher et analyser les causes de défaillances, et proposer des solutions innovantes pour y remédier.
– Capacité à établir des liens entre les concepts et à faire preuve de recul (helicopter view).
– Autonome et flexible.
– Faculté à comprendre, à suivre et à faire siennes les décisions prises avec le line manager.
– Esprit analytique et capacité de raisonnement logique marquée.
– Méthodique, rigoureux, proactif et organisé.
– Orienté(e) qualité et client (manager CSV).
– Facilité à travailler en équipe et à soutenir ses collègues, à communiquer et à parler d’une seule et même voix.
– Franchise, éthique, honnêteté, respect & intégrité.
– Capacité à coordonner différents projets en même temps.

Notre Offre
Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .

• Location: Braine l'Alleud
• Job #24144

R&D clinical
Contracting – Braine l’Alleud
Our client is looking for a profile to fill a position in R&D clinical development. The role involves clinical studies in F1 and F2.

What are the responsibilities?
• Activities related to the design, and everything related to the analytical development.
• Taking the lead on protocols studies

Experience and Knowledge requirement
• Proven project management skills
• Experience in medical monitor for vaccines studies
• Degree or background in the medical field or proven experience
• Nice to have: clinical method development plan management
• Fully fluent in English both written and spoken

Our offer?
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]