• Locatie: Braine-l'Alleud
• Vacature #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]

 

• Locatie: Braine-l'Alleud
• Vacature #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.

• Locatie: Braine-l'Alleud
• Vacature #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. 
 

• Locatie: Braine-l'Alleud
• Vacature #24897

Expert Automation

Walloon Brabant – contracting

As our Automation Expert, you will ensure good engineering practices and design put in place to make sure our new Manufacturing Plant project meets the company expectations and strategy for all assigned packages.
You will also implement tactical strategies in a lean and efficient way. You track and report the progress up to the support model strategy implementation. 

Your responsibilities?

• Ensure good engineering practices for automation
• Ensure for your packages that deliverables will be provided timely and aligned with project planning with the right expected quality and according to the allocated budget
• Collaborate closely with Automation Integrator company
• Align design expectations with the other project disciplines : process, automation, QA, C&V, E&I,…
• Manager consultant engineers tems and sub-contractors to implement tactical automation strategy
• Align and translate process strategies (production, cleaning, sterilization) between process equipment and automation systems
• Align design expectations with the other
• During plant operation, ensure plant support in term of automation and troubleshooting
• Anticipate, manage and report risks from Detail Design till validation batches
• Verify project documentation coming from Engineering Company and Automation
• Integrator
• Challenge process design to ensure alignment between equipment
• Participate and define overall automation strategy for our new BioManufacturing Plant (Library, Recipe structure, HMI philosophy, reporting, alarm strategy, etc.)
• Manage the team of Engineers to deploy automation strategy
• Follow ‘up Automation Integrator and Vendor Packages during development and execution
• Verify automation deliverables and anticipate any cost increase
• Proactively report and manage risks
• Organize operator training
• Perform handover to operation and support team
• Manage punch list related to its packages
• Translate process improvement / modifications into automation requirements
• Ensure efficient handover to operation teams and ensure they will be trained to operate the automated installation
• After handover be part of the Automation Engineering local team and support manufacturing activities (24/24 guard)
• Support and troubleshoot installations to guarantee process Drug Substance manufacturing

Your profile?

• Industrial or Civil Engineer Degree
• Experienced in Engineering projects in GMP environment
• Minimum 5 years’ experience in Bio-Process and/or Automation
• Proven involvement in significant major engineering projects, including risk/mitigation management
• Goof level of French and English
• Strong knowledge of cGMP
• 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
• Able to reach team decision and high sense of responsibility
• Ability to challenge and argument
• Ready to travel a limited period of time

 

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. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]  

 

• Locatie: Braine-l'Alleud
• Vacature #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] .

• Locatie: Braine-l'Alleud
• Vacature #24867

Automation Engineer
Contracting – Braine l’Alleud
The Responsibilities

• Verify project documentation coming from Engineering Company and Automation Integrator.
• Challenge process design to ensure alignment between equipment.
• Participate and define overall automation strategy for our new BioManufacturing Plant (Library, Recipe structure, HMI philosophy, reporting, alarm strategy, etc.)
• Manage the team of Engineers to deploy automation strategy.
• Follow ‘up Automation Integrator and Vendor Packages during development and execution.
• Verify automation deliverables and anticipate any cost increase.
• Proactively report and manage risks.
• Organize operator training.
• Perform handover to operation and support team.
• Manage punch list related to its packages.
• Translate process improvement / modifications into automation requirements.
• Ensure efficient handover to operation teams and ensure they will be trained to operate the automated installation.
• After handover be part of the Automation Engineering local team and support manufacturing activities (24/24 guard)
• Support and troubleshoot installations to guarantee process Drug Substance manufacturing.

Skills and Knowledge Requirements

• Minimum 5 years’ experience in Bioprocess and/or Automation
• Proven involvement in significant major engineering projects, including risk/mitigation management.
• Goof level of French and English
• Strong knowledge of cGMP
• 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.
• Able to reach team decision and high sense of responsibility.
• Ability to challenge and argument.
• Ready to travel a limited period of time.

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. 
 

• Locatie: Braine-l'Alleud
• Vacature #24818

Clinical drug delivery devices lead

Brabant Wallon – contracting 
 

What are your responsibilities?

As a Clinical Drug Delivery Device Lead, you will report to the Head of Device Transversal Services and you will work as a subject matter expert to select and/or assess drug delivery devices used in clinical trials (ie. injection pumps, infusion lines and bags, needles and syringes for iv and sc administrations, oral syringes and dosing cup, etc…). You will be part of a global and highly collaborative multidisciplinary team.
 
What you’ll do  

• Define and implement the overall strategy for the various drug delivery devices to be used in the clinical trials.

• Work with a cross-functional team (including clinical, QA, RA, safety and SME teams) to ensure timely support to clinical trials.

• Lead the Clinical Drug Delivery Devices sub-teams to ensure appropriate selection and assessment of drug delivery devices to be used in the clinical trials.

• Perform the technical assessment for devices used in clinical trials and selected by our CROs.

Who are you ? 

• A master’s degree with a relevant academic background, ideally a nurse or a physician
• 8+ years of experience in a clinical drug delivery devices selection
• Very good knowledge of medical devices and pharmaceutical environments
• Experience in clinical trials set-up
• Understanding of the issues and challenges of selecting appropriate and fit for purpose devices from FIH to Phase 4 clinical trials studies
• Thorough knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and in GxP (GMP and GCP)
• Experience in drug-device compatibility testing and material of contact assessment is a plus
• Project management skills
• Leading and influencing cross-functional and matrix teams
• Excellent writing skills
• Autonomous and detail oriented

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. 

• Locatie: Braine-l'Alleud
• Vacature #24797

MSAT Lab Scientist

We are looking for a Manufacturing Sciences & Technology (MSAT) Lab Scientist who is dynamic, experienced, and collaborative to join our Global Biologics MSAT team, based at our campus in Braine-l’Alleud, Belgium.

The Responsibilities

• Conducting cell culture experiments (including cell expansion, mAb production in glass and single use benchtop bioreactors)
• Providing cell culture lab support for Technology Transfers, Process Validations, Manufacturing operations and deviations/investigations as required, by execution of appropriate cell culture experiments within MSAT.
• Working with the MSAT Lab team to deliver cell culture milestones.
• Establish close partnership with development and commercial manufacturing groups worldwide, serving as a representative of the department in cross-functional project teams.
• Adhere to the company’s Health, Safety & Environment (HSE) policies.
• Coordinate, design, and execute lab experiments applying Quality by Design standards and resources.
• Ensure accurate documentation of experimental protocols, data, and reports.
• Support the development and update of MSAT lab policies and procedures.
• Provide cell culture lab support for technology transfers, process validations, and manufacturing operations.

The Skills and Knowledge Requirements

• An M.Sc. degree in Biology, Biotechnology, Chemical Engineering, or a related discipline
• A track record in cell culture activities
• 3 – 5 years of experience in cell culture
• Excellent problem-solving and communication skills
• Fluency in English is mandatory, with knowledge of French being advantageous.

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.

• Locatie: Braine-l'Alleud
• Vacature #24781

Project Engineering Lead
Contracting – Braine l’Alleud

The Responsibilities

• Is accountable of the design and execution of his projects – mainly in management of some different projects/program (multiple/interaction management of dashboard, status advancement and health for each project/program).
• Coordinate and manage activities with partner (engineering company) during projects design & execution (all portfolio of projects/program will be produced with Engineering company).
• Coordinate all technical activities and planning for execution of a project.
• Have a larger understanding of all related disciplines to challenge/review globally and identify potential issues.
• Have a relevant or previous experience in Pharma (rules GXP, GMP or GLP) and have expertise in Integrate (Planisware SW) Infrastructure, Security or Annex 01 is a must.
• Is also person of reference of overall project activities – cost, schedule, quality, risk mgmt., Gate mgnt,…
• Project point of contact with management, business clients, external or engineering companies and technical team.
• Alignment with global standards – technical, green, safety, GMP, …
• Partnering with engineering firms to ensure proper support in delivering the project designs & execution.
• Working with our Business Expert to define the best solution to meet customer needs.
• Managing cost and planning for all engineering projects activities.
• Managing Basic / Detailed design and execution.
• Ensuring resources identified without gaps nor overlap.
• Handling project governance, budget controlling in accordance with PMO requirements (dashboard of multiple projects).
• Overseeing the project team supervision (with Engineering company).
• Consolidating and reviewing specifications (e.g. URS, Technical Specifications) with team project members and Engineering company.
• Ensuring strong communication with stakeholders and Engineering company.
• Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement, and collaboration.
• Dealing project engineering package of medium to high complexity.

Skills and Knowledge requirements

• Ability to take initiative and work in a team environment.
• Strong value commitment.
• Experience in (complex/multiple) projects.
• Both formal and informal leadership / coordination.
• Experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models.
• Manages with a matrix of reporting lines and across functional areas.
• Ability to share good practices and knowledge.
• Excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
• Leadership experience for the management of internal and external resources.
• Ability to apply previous learning and ideas to new situations, projects, and teams, developing creative solutions to manage risk to a reasonably practicable level.
• Strong reporting, interpersonal and leadership skills.
• Able to translate customers’ needs in projects requirements.
• Full professional proficiency in French and English (both oral and written).

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.
 

• Locatie: Braine-l'Alleud
• Vacature #24752

ADME in vivo Scientist

Contracting – Braine l’Alleud

The Responsibilities
• Independently design and execute pharmacokinetic studies, analyze, and interpret data, and presenting findings back to project teams
• Recommend and lead new strategies within the DMPK department
• Apply your understanding of surgical techniques to provide mechanistic study support for our projects
• Develop and implement state-of-the-art technologies

Skills and Knowledge Required
• A degree in biological sciences or related discipline, PhD would be advantageous
• Demonstrate experience with a range of in vivo DMPK models
• Experience in the pharma or CRO industry with hands on experience of in vivo ADME activities in drug discovery support. This will include routine and mechanistic investigations to support the understanding of the clearance and disposition of new drugs.
• Knowledge of the range of ADME and analytical methods available to drug projects
• Be able to demonstrate the ability to collaborate and influence in a multidisciplinary team
• Publication and presentation record
• FELASA B Belgium personal license for in vivo work

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]