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.
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]
Construction Safety Coordinator – Senior The mission The construction EHS coordinator shall be a competent construction professional, responsible for checking that the project construction activities are executed safely in accordance with the company’s requirements. What are the responsibilities? • coordinate construction activities and liaise with the Host Site EHS team • review safe methods of working ahead of work starting • lead daily safe work planning sessions e.g. SPA, RAMS, PTW • participate in daily prestart workforce safety briefings • participate in safety meetings and lead daily safety walks of the site • participate in toolbox talks • assist in incident investigation • induct / orientate the workers • identify and control new workers • identify general and specific safety hazards to the workers • inspect and conduct safety audits of tasks and safe systems / processes • ensure that all incidents are reported • participate in incident investigations • ensure workers only carry out tasks for which they are trained and qualified • ensure risk assessments and method statements are in place and in use • encourage and participate in the behavioural safety system • intervene and correct any unsafe conditions • participate in safety meetings • ensure good housekeeping and organised tidiness (5S) at all times
Experience and Knowledge requirement • Experince in construction management of medium and large capital projects • EHS experience Soft Skills: • Project and people management skills with thorough knowledge of construction • Communication and collaboration skills
Education, Methodology & Certification Requirements; • University or college training in engineering or EHS • Formal safety professional certification
ICT Skills (software, operating systems, hardware, etc.); MS Office
Language Proficiency Requirements: English – Business French – Fluent
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]
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.
