Our partner is looking for a SME E&I to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Act as the technical reference for contracts related to its area of expertise.
Expert in his/her field of expertise
Author of specifications, calculations and drawings relating to his field of expertise
SPOC for contractors selected to build the facility in his field
Collaborate with the company package owner to manage the contract: planning, budget, quality of execution.
Who are you ?
Knowledge in electricity, high and low current. Experience in electricity in the pharma field (data, access control, …).
Proven experience in CAPEX projects
5+ years of experience in engineering for industrial and/or pharmaceutical environments
Experience in the biotech environment in the bio-pharmaceutical industry is preferred.
Knowledge of safety, GMP, and environmental regulatory requirements.
Experience in legal conformity and energization process (3 green lights), proven experience in qualification
• Soft skills:
Senior profile, minimum 10 years of experience in the field.
Proven experience in qualification; knowledge of Verification (ASTM E2500) is a plus
Good communication, rigorous, fully capable of acting on own initiative
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.
Vos responsabilités ? L’équipe Supply assure les différents flux logistiques et supporte les activités de productions. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP du BioPilot. Ils contribuent à la gestion de la logistique (Commandes, réceptions, transferts entre magasins, vêtements de travail, approvisionnement de matières, élimination de déchets,…).
Coordination de projet – implémentation de XFP
Être le point de contact pour le projet d’implémentation de XFP
Prendre le lead et suivre les actions bloquantes ou en attente pour l’implémentation de XFP
Diriger ou soutenir l’implémentation de solution relatif à l’implémentation de XFP
Former les équipes opérationnelles à l’utilisation de XFP
Participer à l’écriture, la mise à jour des procédures impactées par l’implémentation de XFP
Soutenir l'équipe opérationnelle pour la fabrication de DS après la mise en oeuvre de XFP
Votre profil ?
Très bonne connaissance de SAP
Bonne connaissance Excel, Word, Powerpoint
Expérience dans le contact fournisseur
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.
Associate Scientist Our client is looking for a Associate Scientist to join its team. The team is based both in Slough and Braine and is responsible for developing processes – scale up and piloting of the processes (cell-culture processes – focused on the upstream side of the process). One important aspect is harvesting – once the cells are grown in the bioreactor, and they get them to express the product, the team has to crude purification to remove cells from the product. The type of cells are CHO cells. Another aspect is understanding the scaleup and the transfer to the next scale of the manufacturing in the BPP biopilot (GMP facility).
In short, growing cells, developing the process, keeping them healthy and getting them to express the biologic molecule that is then purified and eventually reaches the patient.
Working with: • Benchtop bioreactors systems, such as Amba systems, Sartorius, • Larger scale piloting systems • single-use bioreactors • shake flasks, • anything on which cell process can be run
What are the responsibilities? The position is primarily lab-based: – A mix of documentation. – Preparing the protocol and the documents. – Preparing the experimental designs and preparing the experiments. – Making buffers – Preparing meetings. – Building bioreactor vessels – Sterilizing equipment – Running the bioreactor – Keeping the cells nice and healthy throughout the whole process – Monitoring, measuring, taking samples, recovering the product – Doing harvest and clarification – Working with colleagues from other departments. Experience and Knowledge requirement Must have – Process development experience – Knowledge of cell culture and bioreactor processes (any scale, pilot scale preferably) – Experience with benchtop bioreactors systems, such as Amba systems, Sartorius, larger scale piloting systems, single-use bioreactors, shake flasks, aseptic techniques, etc. – Minimum 2 years of experience – Fully fluent in English, French is a nice to have
Nice to have – Knowledge/experience with harvesting and clarifying processes – clarification, centrifugation, centrifuge operations, filtration – Experience with antibody expression, recombinant protein expression – GMP experience
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]
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]
Sites and Infrastructures Partner Our client is looking for a Sites and infrastructure Partner to join its team. The role Sites and infrastructure Business Engineering Partners serve as the central point of contact and a robust bridge connecting the Business area, Engineering, and Project Leaders for various facilities infrastructure aspects (such as buildings, roads, parking, landscaping….). The role includes:
Strategic Perspective: Consolidate the overall technical perspective of thebusiness area.
Budget and Feasibility: Accountable for delivering feasibility and design studies.within the budget for the 10-year plan.
CAPEX Coordination
Engineering Support: Sites and infrastructure Business Engineering Partnerscoach and mentor Engineering Managers, ensuring strong technical deliverables forCAPEX Projects.
Resource Allocation
What are the responsibilities?
Understanding Customer Needs:
Gather and comprehend requirements from customers.
Assist customers in articulating their needs to create a GP0 (General
Proposal).
Scenario Development:
Think creatively and prepare various scenarios.
Present these scenarios to stakeholders.
Project Initiation (GP0 Approval)
Support the Sponsor or Idea Owner in launching the project.
Collaborate with the Technical Engineering Team to identify the Project
Leader (PL) and establish the team structure for GP1 (Detailed Proposal).
Drive the project toward achieving GP1.
Coach the Project Leader on following the methodology.
Participate in Project Steering Committee (SteerCo) meetings.
Connecting Customers and Global Engineering:
Serve as the liaison between customers and the Global Engineering
structure.
Communicate customer requests to the engineering team.
Assist the engineering team in resource allocation, technology planning, and
high-level resource needs.
Relay project-related issues from Engineering to customers (Global
information).
Monitor and facilitate the handover process.
Experience and Knowledge requirement
Minimum 5 years in Infrastructure projects like Project Leader or Team Manager
Minimum 1 years within chemical, pharmaceutical or biotech company with minimum technical background (process and utilities).
People management with a minimum of 2 years in a Production/engineering environment as supervisor or manager.
Project management with a minimum of 5 capital projects succefully delivered and experience in capital project management up to min 10 mioEUR.
Experience in risk management (and related specific tools (FMEA, HAZOP)
Experience in capital and asset management is an asset.
Experience in Masterplan building
Fully fluent in English and French
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]
CSV EXPERT Contracting – Braine l’Alleud The mission: New MES projects for both manufacturing & Lab’s 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). The focus is on Manufacturing (MES) like Siemens Opcenter, but there is a potential evolution to Laboratory and Industrial. The mission includes Test creation, execution monitoring and GMP/GDP projects.
What are the responsibilities? • 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 UCB IT Compliance Lead • Support Medior/Senior to Review project test execution review in QALM • Create / Update IT Validation template
Experience and Knowledge requirement Must-haves: • Minimum 3 to 5 years of experience • Experience required in CSV, GAMP5, with a minimum of 1.5-3 Years of experience in CSV • Fluent in English
Nice-to-haves: • QALM • LIMS, Empower, ELN • French is a big plus (business is French-speaking)
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]
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]
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]
It is imperative to have used these techniques in an analytical environment.
Are you the candidate we're looking for?
Bachelor's or Master's degree in Analytical Biochemistry
Knowledge of liquid chromatography, size exclusion, etc.
Fluent in English
MUST HAVE:
Laboratory skills
Substantial experience in at least one of the above techniques
NICE TO HAVE:
Understanding of GMP + strong communication skills
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
Our client is looking for CVS expert to join its team.
What does the team do? Part of the IT Compliance Solution team responsible for all the validation of IT computerized systems across the company. There are 5 IT Compliance Leads for each particular domain. Each monitors oversees a team of validations CSV Experts (SMEs) who are working on the day-to-day activities (on the actual validation work)
What are the responsibilities ?
Task / Daily activities: • Accountable for the validation strategy for the systems in their scope • Overseeing everything related to the projects’ submission – review the project charter, assign the resources, establish the strategy for the validation • Reviewing/approving documentation • Management of the resources • Doing everything related to the compliance of the systems – change management, periodic review, deviation procedures update, etc.
Experience and Knowledge requirement
Years of experience in the position: min 5 years of experience
Must have criteria (focus on hard skills/specific tools experience)
• Expertise in validation – need to have an understanding of validation strategy and be able to establish a validation strategy by themselves (autonomy required)/ Ability to manage/review project
Nice to have criteria: • Veeva Suite (for the document and deviation management) • ITSM for incident management • Trackwise, Sharepoint, etc.
Mandatory language: English (French 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]
