Industrial Lead Analytical (ILA) Associate The scope of the position is global within the entire Supply & Technical Solutions (S&TS) network of the Company. The role is focused on supporting, from an operational and project execution standpoint, the Analytical Industrial Lead of commercial products, from late phase development (for commercial readiness) to the end of the life cycle of products. What are the responsibilities? • Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …) • Implementing analytical life cycle plans or integrated analytical solutions through project management • Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department • Supporting ILAs for operational activities within the remit of the department. • Connect with people to develop and maintain interfaces with operations (e.g. QC laboratories, CMO, CLO) • Use your project management skills to implement decisions, plans and solutions • Show-off your energy and dynamism to evolve in a complex matrix environment • Work in autonomy with a problem solving & pragmatic mindset. • Work on several projects in parallel with agility and smooth communication to support members of the team
Experience and Knowledge requirement • Proven project management skills including planning, monitoring, issue resolution, risk mitigation and reporting • Exposure to GMP, Regulatory Affairs and Quality applied to analytical • Fluent in English and French • Customer and results oriented • Ability to summarize challenges and issues to management • Knowledge of basic Microsoft tools (Teams, Excel, powerpoint,..) • Ability to review data and documentation with a scientific eye • Knowledge of pharmacopeias and Physchem methods is a plus
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]
Our partner is looking for a Computer System Validation to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of Technical Change Description
Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
Reviewing of CVS specific SOP’S and Templates
Ensure the proper execution of the qualification and validation activities with respect of the company validation methodology
Who are you ?
University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
You speak French and English
Certification in computer system validation or equivalent is a plus.
Experience in a computer systems validation role
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
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.
The mission New MES projects for both manufacturing & Labs scope – the goal is to support the activities creation of Test script in Opcenter or XFP and MES for Siemens and to support the validation of IT applications in the labs (Empower, LIMS, ELN)
Day-to-day activities • Create, Test script and review execution in QALM • Creation of all documents in SourceCD based on the Source CD procedures and on the validation approach (deliverable list) approved by a the IT Compliance Lead • Support Medior/Senior to Review project test execution review in QALM • Create / Update IT Validation template
Profile Must-haves: – Experience required – CSV, GAMP5 a minimum of 1.5-3 Years of experience in CSV – English
Nice-to-haves: – QALM – LIMS, Empower, ELN – French is a big plus (business is French-speaking)
Minimum number of years of experience: 3-5 years
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]
Our partner is looking for a Project Manager – Business Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Design the project organizational structure and assigns responsibilities. Ensure team members are completing their tasks according to plan.
Contribute to the development of the RFP strategy definition
Support and ensure that local teams are collecting RFP requirements according to plan.
Manages risks on the project through periodic identification with the team and stakeholders, prioritization and manages the countermeasures and/ or mitigation.
Foster relationships between Vaccines and Medicines global teams (Procurement, Engineering, QA, EHS..) and local Engineering/Procurement teams from 6 countries.
Support Global Procurement during the supplier selection process (meeting schedules, action log, minutes of minute, technical and commercial clarification, decision criteria, sourcing approval).
Carries out performance management on the project, escalating issues in a timely manner and reports monthly
Design and deliver solutions and processes in support of project objectives and requirements.
Ensure the overall project plan, timeline, risks and issues are being managed effectively by the teams.
Ensure that the knowledge base (information and people) is developed and maintained, ensuring effective transition of knowledge into the support organisation.
Ensure holistic communications planning ansd stakeholder management approach is in place and active with each site.
Ensure that training needs are identified, defined and delivered accordingly
Participate and support project steering meetings Review outsourcing strategy
Deploy FM contracts, and oversee the transition, mobilization and stabilization phases of the contract deployment with the implementation of monitoring tool, business continuity plan and exit plan
Who are you ?
Ability to work in French and English
Master in Engineering or Business
At least 8-10 years in industrial projects (engineering, maintenance)
Experience in Operation Excellence including Maintenance Excellence
Good knowledge of the international Facility Management market
Knowledge in Procurement process and contract management
Skills in Perfomance Management (LEAN culture, Continuous Improvement)
Proven track record in project management, including global RFPs
Know-how of engineering activities within the pharmaceutical industry
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.
Ben jij een freelancer en op zoek naar een extra opdracht? Heb je een technische achtergrond en ervaring met het valideren en controleren van machines, tools en documentatie in industriële omgevingen? Dan is deze opdracht zeker iets voor jou!
Voor een grote, internationale speler in de Automotive industrie zijn we op zoek naar een Validatie Engineer regio Gent (m/v/x). Voel jij jezelf klaar voor deze uitdaging? Wil je samen met Jefferson Wells deze uitdaging aangaan? Lees dan zeker verder!
Jouw verantwoordelijkheden? Als Validatie Engineer ben je verantwoordelijk voor het valideren van nieuwe installaties volgens de specifieke standaarden van de klant. Je zorgt voor fysieke inspectie, controle van documentatie en detectie van afwijkingen gedurende de verschillende projectfasen. Het is essentieel dat je vertrouwd bent met Europese machinerichtlijnen en algemeen geldende technische normen. Hoewel functionele testen niet tot je taken behoren, wordt een mindset van continu verbeteren ten zeerste gewaardeerd.
Wie ben je? Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Validatie Engineer over een technische diploma en heb jebewezen ervaring en kennis in Europese machinerichtlijnen en technische normen. Je toont voldoende flexibiliteit om 1 dag per week aanwezig te zijn gedurende enkele maanden om vertrouwd te raken met de standaarden. Later zal dit eerder project gebaseerd zijn.
Wat kan je verwachten? Als freelance validatie Engineer kom je terecht in een dynamische en open werkomgeving met aangename collega’s zowel bij de eindklant als het Jefferson Wells Consultancy team.
Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Sara Van den Bossche op het nummer +32 (0)4 72 79 10 42 of via Sara.vandenbossche(@)jeffersonwells.be.
Permanent or Freelance Contract – West Flanders #supply chain #specialist #logistic Do you have a degree Supply Chain Management or Business Administration? Do you have work experience in Logistics / Supply Chain? Do you enjoy contributing to the transport of the future? Then keep reading!” Our Partner is a leading organization in the automotive sector, situated in West Flanders and is dedicated to delivering high-quality products/services to their valued customers. They are committed to innovation, sustainability, and excellence in all aspects of their operations and are seeking a dynamic and experienced Supply Chain Specialist to join the team.
Key Responsibilities:
You will mapping Interco Projects: Coordinate and manage intercompany projects, ensuring seamless execution and adherence to project timelines.
You define annual price lists and negotiate terms with intercompany stakeholders to ensure competitiveness and profitability.
You optimize the Logistic Flow: Identify and implement strategies to optimize intercompany logistic flows, with a focus on reducing delays and improving efficiency, particularly for free issues.
You will monitoring QCD Performance : Monitor and analyze Quality, Cost, and Delivery (QCD) performance metrics, identifying areas for improvement and implementing corrective actions.
You initiate direct purchases where necessary, ensuring compliance with company policies and procedures while maintaining cost-effectiveness.
You develop and implement initiatives to reduce intercompany Total Cost of Ownership (TCO) by 15%, through cost-saving measures and process improvements.
Who are you? To successfully carry out the above tasks and responsibilities, as a Supply Chain Specialist, you have a bachelor/ master's degree in Logistic Management or equivalent through experience, You have good communication skills in English. Additionally, you have a proactive attitude and possess analytical skills. Finally, you are an independent individual with strong communication skills. What can you expect? As a Supply Chain Specialist you will find yourself in a dynamic and open working environment with pleasant colleagues. Moreover, you will receive an attractive salary supplemented with an extensive package of fringe benefits and an immediate permanent contract of indefinite duration. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Does this position meet your expectations? Then apply directly via the website or contact Martine Vergote at +32 (0)4 95 36 51 42 or via martine.vergote(@)jeffersonwells.be
Vast kontrakt of Freelancer – Regio West-Vlaanderen #Teamleader#technisch#PeopleManager#
Beschik je over een Bachelor/ Masterdiploma in een technische richting of ben je gelijkwaardig door ervaring? Heb je minstens 5 jaar ervaring in een leidinggevende rol? Ben je een echte people manager en werk je georganiseerd? Dan ben jij de persoon die we zoeken !
Voor een klant zijn we op zoek naar een ervaren Teamleader (m/v/x) om het productieteam van ongeveer een 50-tal medewerkers te versterken . Dit internationale automotivebedrijf is gelegen in West-Vlaanderen.Wil je samen met Jefferson Wells deze uitdaging aangaan? Lees dan zeker verder.
Our partner is looking for a Global Quality Lead Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
This position provides support to a Global Quality Lead relative to Quality Assurance activities associated with the lifecycle management for a product transitioning from Development to Commercial by:
Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
Maintenance and lifecycle management of QA product flows
Audits and Inspection anticipation and readiness
Review of Annual Stability Plan
SOPs and other control documents writing, review and approval as needed
Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
Who are you ?
You already worked in GMP environment for 5 years
You are experienced in operating across cultures and in a multi-cultural environment
You have experience in GMP audits and inspections would be an advantage
You are Fluent in French and your English is not bad
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.
For our client specialized in the energy sector, we are looking for an As Built Designer
What are your responsibilities ?
To insert new grid configurations into the database based on the content of infrastructure projects.
Drawing the geographical as-built model of the underground connections. This includes new connections and adjustments after cable relocations and repairs.
Input of geographic data related to the terrains and buildings based on the delivered documents (e.g. The project note, scenario, construction plans, as-built plans…).
You follow up the data delivery yourself.
You continuously follow up the evolution of your projects in order to plan your own work and provide your stakeholders with the timely input.
You permanently take care of your projects up to and including the acceptance and approval of the as built design.
You are an expert in handling or organizing data in an operational context with the aim of improving the overall data quality.
Who are you ?
You have experience with the use of databases.
You have a thorough knowledge of Autocad
You have technical knowledge of electrical installations
You have a good knowledge of FR/NL/ENG.
You are organized, quality-driven and customer-oriented.
You are a good communicator and you have good interpersonal skills.
You have a good team spirit and you are able to support the other team members when necessary.
You work autonomously and accept your responsibilities.
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.
Are you interested in this job? Don’t hesitate to apply !
Pour notre client spécialisé dans le secteur ferroviaire, nous sommes à la recherche active d'un Ingénieur en installation électrique
Quelles sont vos responsabilités ?
Conception d'armoire électriques
Transformer les schémas de principes électriques en une installation embarquée réelle
Construire la nomenclature correspondant à l'installation et conforme aux contraintes et normes du train,
Dessiner les schémas définitifs et générer la liste de câblage associée
Concevoir des harnais respectant les normes ferroviaires et rédiger les spécifications pour leur production
Collaborer avec les ingénieurs mécaniques pour établir la liste des pièces détachées ou la solution d'installation finale
Rédiger une procédure d'installation expliquant les activités d'installation à réaliser
Qui êtes-vous ?
Master orientation en conception électrique
Min 3 ans d'expérience au sein d'un bureau d'études est requis
Connaissance d'un logiciel de conception électrique
Connaissance de V-cycles
Compétences rédactionnelles
Savoir communiqué tant à l'oral qu'à l'écrit en français et anglais
La connaissance du PLM – ENOVIA est un atout
Esprit d'équipe
La connaissance des chemins de fer est un plus
Rigueur et ouverture d'esprit
Autonomie et persévérance
Que pouvez-vous espérer ?
Jefferson Wells vous propose un CDI avec un package salarial attractif et vous donnera accès à des formations en matière technique et soft skills. Nous serons votre partenaire de carrière à chaque étape du processus.
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