• Location: Braine-l'Alleud
• Type: Contracting
• Job #15201

HVAC Expert 

Walloon Brabant – Contracting

#Engineer #Pharma #HVAC #Project #Expert #SME 

Le scope de cette mission est de pouvoir assurer la réalisation/la revue de l’étude de l’installation HVAC de plusieurs bâtiments en cours de rénovation/transformation, et de pouvoir assurer le suivi de l’installation et le troubleshooting le cas échéant.

Vos responsabilités ?

• Représenter l’expertise HVAC sur différents projets
• Assurer la consolidation planning projet de la partie HVAC avec le project leader et/ou le coordinateur technique
• Etablir le cahier des charges
• Réaliser, ou revoir le cas échéant, la partie étude de l’installation technique HVAC (Dimensionnement, calculs, etc)
• Assurer le suivi de l’installation par le sous-traitant, en s’assurant que l’installation est installée dans le respect du cahier des charges
• S’assure que le planning sous-traitant est maintenu et communiquer directement tout écart vers le Project leader
• S’assurer, lors de la réalisation ou de la revue de la partie étude, que tous les aspects énergétiques ont bien été pris en compte pour limiter au maximum l’emprunte carbone
• Assurer le cas échéant le troubleshooting et met tout en œuvre pour solutionner rapidement les problèmes rencontrés.

Votre profil ?

• Vous avez un diplôme d’ingénieur (industriel, civil,…)
• Vous avez une expérience de minimum 5 ans dans une position équivalente en industrie pharmaceutique.
• Vous êtes méthodique, orienté(e) résultats et avez une bonne aptitude à la communication.
• Vous parlez français et anglais (intermédiaire).

Notre offre ? 

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matière technique ainsi qu’au niveau des soft skills. Nous serons votre partenaire de carrière à chaque étape du processus. Vous êtes intéressé par ce poste ? Nous vous invitons à postuler.

Avez-vous des questions ? Vous pouvez contacter Anaïs Malikian, [email protected] 

• Location: Braine-l'Alleud
• Type: Contracting
• Job #15181

Formulation Development Scientist

Walloon Brabant – Contracting

#Pharma #GMP #Formulation #Antibodies #Scientist  

What are your responsibilities?

The lab-based role is:

• to support the development of formulation of monoclonal antibodies through the application of manufacturing (buffer exchange) and analytical techniques (size variants, charge variants, UV spectroscopy, DLS, CGE,…) 

The main deliverables of the role are:

• prepare formulations of antibody for stability studies
• collect experimental data following established analytical methods
• write accurate and precise experiment reports, for all activities follow Good Scientific Practices
• help generate study protocols and reports to justify the selection of preferred NBE formulations 

Who are you? 

• Biology or Analytical chemistry degrees or equivalent
• 2 years of industrial experience, experience with analytical techniques or/and formulation, ideally with proteins/antibodies derived molecules
• Practical laboratory skills with HPLC/UPLC (especially size exclusion), charge variants, UV/Vis spectroscopy, DLS, CGE, rheology, …
• A working knowledge and practical laboratory experience of antibodies and their formulation would be a plus
• Experience in writing accurate and precise experiment reports
• Experience with data analysis and interpretation, protocols and summary report writing would be a plus
• A working knowledge and practical laboratory experience in GxP would be a plus
• Technical english is mandatory
• Familiar with creative, flexible, fast pace and stimulating environment in a multidisciplinary team

What can you expect?

We offer you an open-ended contract as well as an attractive salary package. You will also take advantage of the opportunity to develop yourself personally and professionally through internal training.

Interested? Do not wait any longer!

Apply directly via our website WWW.JEFFERSONWELLS.BE or send your CV to the following email address [email protected]

• Location: Braine l'Alleud
• Type: Contracting
• Job #15151

QA Development Lead

Contracting – Walloon Brabant

#qa #qualityassurance #cmc #pharma #operational #process

Do you have experience in a GMP manufacturing? Are you rigorous? Do you speak fluently English? Keep reading your future job description.

Our partner is looking for a QA Development Lead to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

As a part of the Development Product Quality management team, the QA Development Lead’s main tasks will be:

– Operational :

• Ensure the CMC project related QA activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house)
• Ensure the QA project support of the CMC process development including analytical work, technology transfer, CMC filing, … from early phase to commercial launch of the product.
• Ensure adequate documentation processes and systems are available and followed for CMC development projects (SOPs / Protocols review /approval)
• Proactively support the activities of CMC and Development QA for relevant quality systems (deviation close out / Change management/ complaints / quality improvement)
• Advise CMC development sub-teams and the wider CMC community regarding strategy, timelines, logistics and give support to operational issues in order to assure regulatory compliance and ensure scientific consistency across CMC development projects.
• Play an active member role of the technical team for development projects
• Be the QA stakeholder for product Risk management
• Identify and/or give support to technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions
• Partner with project teams to address operational deficiencies identified by regulatory Agencies.
• Keep knowledge on CMC guidance up to date and apply as appropriate to development processes.

– Process:

• Ensure that all operations are appropriately compliant with applicable regulations (EMA, FDA, etc. where relevant).
• Actively participate in identifying, developing and implementing improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions
• Ensure CMC and Development QA processes directly support Technical team goals and objectives.

Who are you?

You hold a scientific degree. You have a relevant experience in quality assurance/compliance or in CMC in GMP manufacturing. You speak fluently French and English. You are rigorous and analytical.

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 Marie Defruit, [email protected]

• Location: Braine l'Alleud
• Type: Contracting
• Job #15117

CTS Vendor Manager

Contracting – Walloon Brabant

#CTS #clinicaltrial #supplychain #vendor #packaging #distribution #pharma

Do you have experience in clinical trial supplies? Do you speak fluently English? Are you flexible? Keep reading your future job description. 

Our partner is looking for a CTS Vendor Manager to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

As a CTS Vendor Manager, your main tasks will be:

• Manage and implement complex and strategic projects taking into account the dynamic controls the business evolution will require.
• Manage current vendors as per ENG processes and drive KPIs adherence
• Act as the main point of contact for inspections / audits; coordinate with the CTSO Warehouse and Distribution team when the requirement is for internal documentation for distribution
• Own and manage compliance records on trackwise to support CTS Vendor Management team compliance improvements (change controls, CAPAs, etc)
• Improve the management of Purchase Orders related to CTS vendors services & invoice control
• Financial control of accruals and projection of the future spend according to the evolution of clinical studies
• Understand studies forecasts, tariffs structure and define CTS budget
• Management of KPI's operational and tactical for CTS Vendor Management
• Analyze quarterly financial expenditure for the studies assigned to him/her and compare with budget to support management decisions or escalations

Who are you?

You hold a Bachelor’s Degree and you have a relevant working experience in international pharmaceutical logistics management and/or supply chain expertise with understanding of GMDP and GCP guidelines.You have also an experience with vendor management and you have a good knowledge of clinical trial packaging and distribution practices. You speak fluently French and English. You have a good knowledge of Trackwise, SAP and MS Office. You are able to work under pressure and you are flexible. You have an analytical mindset and excellent communication skills.

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 Marie Defruit, [email protected]

• Location: Braine-l'Alleud
• Type: Contracting
• Job #14952

Validation Engineer

Walloon Brabant – Contracting

#Engineer #Pharma #GMP #Validation #Qualification #Process

Vous avez de l’expérience dans le domaine de la qualification et validation dans le secteur pharma ?

Vous aimez le travail d’équipe ? Vous proposez des solutions innovantes ?

Notre partenaire recherche un Validation Engineer pour rejoindre son département de Process Validation qui a pour responsabilité la prise en charge des activités de qualification et validation du site.

Vos responsabilités ?

En tant que Validation Engineer, vous serez amené(-e) à :

• Supporter les activités de qualification des équipements, de validation de procédés et de nettoyage au sein du département
• Assurer la qualification des équipements de production et de laboratoire
• Préparer les protocoles, les rapports, les analyses de risque, le suivi et/ou l’exécution des tests
• Traitement des déviations et investigations associées

Votre profil ?

• Ingénieur ou de formation équivalente
• Expérience de minimum 2 ans dans le domaine de la qualification et validation dans un environnement industriel pharmaceutique
• Connaissance des bioprocédés et des procédés aseptiques
• Idéalement une connaissance en cleaning validation et/ou process validation
• Vous savez rechercher et analyser les causes de défaillances, et proposer des solutions innovantes pour y remédier
• Vous êtes autonome, organisé(-e) et capable de coordonner différentes activités de qualification en même temps
• Français courant et compréhension en anglais

Notre offre ?

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matière technique ainsi qu’au niveau des soft skills. Nous serons votre partenaire de carrière à chaque étape du processus. Vous êtes intéressé(-e) par ce poste ? Nous vous invitons à postuler.

Avez-vous des questions ? Vous pouvez contacter Anaïs Malikian, [email protected] 

• Location: Braine-l'Alleud
• Type: Contracting
• Job #14733

Shipping qualification and Cold chain Expert

Contracting – Walloon Brabant

#Supply #Chain #Cold #GMP #Pharma #Shipping #qualification

Our partner is looking for a Cold Chain Expert to join its team. This international company is well-known for its pharmaceuticals.

Your responsibilities?

• Act as expert for establishing Global shipping qualification and Distribution systems and solutions for the company Global products.
• Act as expert in the Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM) and simulation testing for temperature-controlled transport packaging (ISTA guidelines and procedures).
• Act as expert in Pharma requirements for temperature-controlled trailers and risk management in temperature-controlled road transportation.   
• Act as the coordinator with passive and active systems suppliers and the external certified laboratory used for testing.
• Provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
• Establish, define and maintain shipping qualification and shipping risk analysis processes that meet current standards and guidance's (Good Distribution practice, Good documentation practice, ISPE cold chain management, process qualification standard and guidance, regulatory requirement)
• Set up and maintain standard templates of shipping qualification test protocols and test reports (URS, OQ, PQ) in accordance with the relevant regulations (European guidelines, PDA technical reports, USP, WHO, IATA, …)
• Develop and implement pharma requirements for temperature-controlled trailers and risk management in temperature-controlled road transportation.   
• Risk management and risk assessment according to ICH Q 9 for transportation including roads, routes, temperature profiles and transport duration as well as on a product basis
• Assessing Vendor data (OQ) for active and passive solutions used in transportation or performing operational qualification (OQ) in collaboration with an external certified laboratory.
• Performing shipping qualification studies (PQ) considering holistic approach on global transportation and replenishment processes
• Working with multiple Sites and CMOs, QA and logistics operations to ensure that products are shipped with compliant and efficient solutions (solutions and processes).
• Monitoring end-to-end performance of shipping solutions, perform trending analysis and periodic review.

Your profile?

• You have at least 5 years relevant and working experience in international pharmaceutical logistics management and/or supply chain expertise
• You have excellent understanding of GDP, product mechanical and thermal protection guidelines
• You speak fluently French and English.

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]