For our client leader in the automotive sector, we are looking for a Battery Modeling Engineer
As part of R&D organization, the Powertrain Division is responsible for local development of powertrains as well as planning and research of new European technologies. Battery team is responsible for not only development of battery pack but also model based design & digital evaluation in both cell and pack level.
Your responsibilities
Research the latest battery modelling approach to develop new and improve existing methods
Understand existing in house methodology
Implement digital approach to design and optimize future battery system
Predict battery aging by simulation
Assess battery cooling and thermal propagation by simulation
Apply the methodology to local battery cells and packs
Apply AI approach and machine learning to improve accuracy and efficiency
Analyze simulation results and test data to draw conclusions
Take a role of expert in the field, contribute to the team overall outcome, support problem solving
Your profile
Engineering degree in electro-chemical
Experience in battery thermal management
Experience in battery modelling
1D and 3D thermal model
Enthusiastic and independent as well as team player
Explain, summarize and report complex technical information in a clear and visual way
Knowledge in MS Office, MATLAB, Simulink, Python, GT power, Comsol, CCM+
Effectively and clear communication in English (written & 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.
Are you interested in this job? Don’t hesitate to apply !
Pour notre client spécialisé dans la distribution de gaz et électricité, nous sommes à la recherche d'un coordinateur travaux – gaz.
Dans le cadre du bon fonctionnement interne de l’organisation, notre partenaire souhaite renforcer son équipe du Bureau d’Etudes Gaz afin de coordonner et de suivre la réalisation sur site du projet « Vitual Pipe ». Ce projet a pour but de construire les infrastructures techniques permettant d’alimenter en gaz naturel certaines « Zones Blanches ». Ces zones blanches seraient ensuite alimentées en gaz vert (biométhane, e-méthane ou hydrogène).
Responsabilités
Prendre connaissance du dossier, réunion d’information avec le coordinateur de projets ;
Prendre connaissance de tous les documents du marché ;
Vérifier tous les documents administratifs des entreprises liés au dossier
Planifier une réunion préalable avec entreprise, impétrants et partenaires
Valider la date de début de marché ;
Participer aux réunions de chantier : codirection de la réunion, médiation, arbitrage, conseil et décision finale. Faire un compte-rendu rapide par écrit.
Vérifier les rapports de chantier
Vérifier les documents administratifs des entreprises
Vérifier la conformité technique des travaux (CSCH, Normes, Code de bonnes pratiques, …)
Assurer la gestion des impétrants
Archiver les documents de chantier (PV, plans EXE, …) ;
Participer aux pré-réceptions techniques et/ou à la réception provisoire
Accompagner le personnel adéquat à la bonne mise en marche du bâtiment y compris organiser les formations techniques nécessaires ;
Faire un bilan du dossier ;
Profil
Min 5 ans d'expérience en gestion/coordination de chantier
A2 ou Bachelier en électromécanique, électricité, énergie ou construction
Formation en Coordinateur Sécurité et Santé
Connaissance d'autocad
Expérience dans des secteurs liées à l'utilisation de gaz
Niveau de français C2
Excellente capacité de communication et de rédaction
Vous prenez en charge l'ensemble des axes principaux de gestion d'un projet
Vous êtes autonome, flexible et travaillez avec un esprit d’équipe.
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.
Pour notre client spécialisé dans le secteur du oil&gas, nous sommes activement à la recherche d'un Ingénieur Process.
L’Ingénieur Process, avec un master en chimie, mécanique ou électromécanique, aura pour mission de définir le process d’une installation de production d'hydrogène par électrolyse et de réaliser les schémas fluidiques associés. Il participera également aux analyses de risques et à la définition des barrières de sécurité.
Responsabilités
Réaliser les P&ID
Rédiger les notices de fonctionnement et les analyses fonctionnelles
Réaliser le bilan de masse et de chaleur
Participer aux HAZOP et faire un suivi des actions
Rédiger les spécifications des exigences de sécurité (Safety Requirement Specification) des systèmes instrumentés de sécurité (SIS)
Effectuer les calculs de zonage ATEX
Profil
Ingénieur diplômé en chimie, mécanique ou électromécanique
10 ans d'expérience dans le secteur de la chimie, du oil&gas ou de la pétrochimie
Expérience dans la réalisation de P&ID et dans la rédaction d’analyses fonctionnelles
Expérience dans le secteur Oil&Gas
Participation à des HAZOP
Maîtrise de la langue française et anglaise
Maîtrise de la suite Office, en particulier Excel
Connaissance des logiciels de dessin de P&ID type AutoCAD
Connaissance en dimensionnement de vannes de contrôle et de soupapes
Que pouvez-vous espérer ?
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.
Pour notre client spécialisé dans les réseaux de distribution de gaz et électricité, nous sommes à la recherche d'un Gestionnaire de Chantier – Hydrogène.
Le projet consiste en la conception, la réalisation et la mise en service d'un “Ecosystème hyrogène en circuit fermé” au sein d'un site propre de la société (bâtiment de type tertiaire avec bureaux et ateliers). Il s'agira de développer un système intégré d'hydrogène renouvelable (site “pilote”) pour analyser et étudier ce gaz neutre en carbone sous différents aspects (production, stockage, distribution locale, pilotage et diversification de ses usages, etc.). Cet ecosystème hydrogène devra pouvoir s'intégrer au bâtiment et à ses techniques (par exemples chaudières, production photovoltaïque, etc.).
Ce projet est subventionné par le Gouvernement wallon et et est par conséquent soumis à des règles d'autant plus strictes en matière de reporting, de planning, d'utilisation du budget, d'atteinte des objectifs et du respect des critères de qualité.
Quelles sont vos responsabilités ?
Dans le cadre du bon fonctionnement interne de l’organisation, notre partenaire souhaite renforcer son équipe “Stratégie et Innovation” au sein de la Direction général afin d'assurer la gestion l'ensemble du projet “Ecosystème hydrogène en circuit fermé”.
La conception, la réalisation ainsi que la mise en service de cet écosystème hydrogène en circuit fermé sera (presque) entièrement sous-traitée et confiée à des prestataires externes. Un partie importante de la mission sera ainsi associée au bon suivi de l'ensemble des marchés publics (depuis la rédaction des cahiers des charges jusqu'à l'atttibution et l'exécution des marchés) nécessaires à l'atteinte des objectifs du projet, en ce y compris les marchés publics liésà l'obtention des permis nécessaires, à la conception de l'écosystème, à l'acquisition des différents composants ainsi qu'à leur installation, leur assemblage et leur mise en service.
Les équipes internes concernées devront également être associées au projet afin de notamment : – assurer la coordination et le reporting nécessaire au sein du programme “Transition Energétique” – permettre et favoriser leur montée en connaissance et en compétences sur les thématiques liées à l'écosystème hydrogène.
Tâches avant le début du chantier:
– Prendre connaissance du dossier, réunion d’information avec le coordinateur de projets ; – Prendre connaissance de tous les documents du marché ; – Vérifier tous les documents administratifs des entreprises liés au dossier – Organiser le début de chantier : – Planifier une réunion préalable avec entreprise, impétrants et partenaires – Valider la date de début de marché ;
Tâches pendant le chantier:
– Participer aux réunions de chantier : codirection de la réunion, médiation, arbitrage, conseil et décision finale. Faire un compte-rendu rapide par écrit. – Vérifier les rapports de chantier – Vérifier les documents administratifs des entreprises – Vérifier la conformité technique des travaux (CSCH, Normes, Code de bonnes pratiques, …) – Assurer la gestion des impétrants – Archiver les documents de chantier (PV, plans EXE, …) ;
Tâches à la fin du chantier (ensemble bâti ou non bâti exploitable):
– Participer aux pré-réceptions techniques et/ou à la réception provisoire – Accompagner le personnel adéquat à la bonne mise en marche du bâtiment y compris organiser les formations techniques nécessaires ; – Faire un bilan du dossier.
Qui êtes-vous ?
– Expérience dans la gestion de projets liés : – à la conception et/ou la mise en place de systèmes énergétiques – et/ou à la conception et/ou la mise en place d'infrastructures – et/ou à des chantiers de construction (type bâtiments tertiaires) – Master ou bachelier en électromécanique / électricité / énergétique /architecte / construction – Minimum 5 ans d’expérience en gestion / coordination de chantiers – Formation en Coordinateur Sécurité et Santé – Maitrise des outils informatiques MS Office, MS Project – Expérience dans les secteurs de la conception/ l'installation/l'intégration de systèmes, composants et infrastructures énergétiques – Expérience dans des secteurs liées à l'utilisation de gaz – Expérience dans les techniques spéciales – Niveau de français C2 – Vous prenez en charge l'ensemble des axes principaux de gestion d'un projet – Vous êtes autonome, flexible et travaillez avec un esprit d’équipe.
Que pouvez-vous espérer ?
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.
Our client is seeking an experienced Project Manager who will play a key part in leading Analytical Method Robustness program. The responsibilities will be coordinating the AMR program, including the Control Tower (agenda, meetings, and minutes), and follow up of the different projects included in the AMR plan. This role will consist of identifying method performance issues based on sites and stakeholder inputs, CMV red flags and CPV issues impacted by QC methods. The PM will also have to coordinate any working group for method issues response.
The PM will be responsible for overseeing project timelines, managing resources efficiently, and enhance project delivery.
Key Responsibilities
• Process Improvement: o Continuously assess the effectiveness approach within the AMR program and identify areas for process improvement. o Implement improvements and adjust practices as needed to optimize delivery. • Facilitation and proactiveness: o Help to proactively identify in time method performance issues o Facilitate working group discussion o DMAIC execution follow up • Change Management: o Help manage and communicate changes effectively within the AMR program and across the organization, addressing resistance to change when necessary. • Cross-Functional Collaboration: o Encourage collaboration and information sharing among cross-functional teams involved in the AMR program. o Promote a culture of continuous improvement and learning across teams. • Risk Management: o Identify and manage risks proactively specific to the AMR program. • Stakeholder Engagement: o Communicate in time with stakeholders o Capture inputs regarding to method performance issue impacting the business • Metrics and Reporting: o Establish and maintain relevant metrics and key performance indicators (KPIs) to measure the progress and effectiveness of the AMR program o Generate reports and dashboards that provide transparency into the program's performance. • Adaptability: o Be flexible and adaptable to changing circumstances, adjusting the hybrid approach and practices as necessary to meet the AMV program's evolving needs. • Value Delivery: o Focus on delivering value to the organization by prioritizing work that aligns with business objectives and customer needs.
Skills and knowledge requirements
• Bachelor’s degree in management areas • Minimum 5 years’ experience in project management in a hybrid environment • Demonstrates competency in project management software and methods • Successful experience in people management • Proven Project Management experience with capability of working independently on multiple projects, and ability to prioritize tasks and meet strict deadlines • Excellent organization skills and ability to operate effectively in a multicultural, matrix organization where the workload requires balancing multiple responsibilities simultaneously • Establish and maintain cross functional relationships. Develop relationships across organizational boundaries
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 Process Workstream Lead to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
TECHNICAL SKILLS
Lead the engineering process team and act as the spoc for all process equipment from design until the handover after verification. Organize his/her team to address to address the best engineering good practice and collaborate with key users.
He/She is in the driver seat, with a full management of supplier, User, QA, EHS, C&V team and will be measure with the success of process equipment implementation.
Strong background within manufacturing USP & DSP (upstream & downstream) bioprocess equipment (Single use systems: bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer), Fill and finish, autoclave and washer.
Expert of single use equipment and aseptic used
Strong knowledge on GEP and global engineering standards.
Ability to Lead P&ID and PFD setup is required, as well as mass balances, FS, HSD, SDS,…
Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
Knowledge and expertise in verification ASTM E2500
Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
Experience in large and complex projects as well as both formal and informal leadership / coordination
Capable to benchmark with peers in the industry and able to identify latest trends
Excellent communication skills in order to present frequent reports to Management.
BASIC & DETAILED DESIGN
Define the applicable standards/norms/engineering guidelines for the project
Provide Engineering offices with the applicable standards
Challenge technical solutions coming from Engineering office
Integrate safety, sustainability and green assessment in the design
Define List of Delivrables for his discipline
Provide project delivrables of his discipline to Engineering Leader
Follow-up on progress/ ETC.
CONSTRUCTION
Based on progress report of the construction manager, perform on a regular basis field spot check follow-up
Organize quality checks on field before each technical milestone activiy.
Communicate the day to day schedule (planning level 4) to the Engineering Leader and construction manager
Ensure a good communication with other Specialists linked to its activity (Battery limits)
Maintain his knowledge accuracy based on new technology. Keep up-to-date
Documentation
Define battery limit and RACI matrix with Engineering Leader
Update drawings in its area of expertise
Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500)
Perform FAT/SAT activities in its area of expertise
Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)
Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the Hand-over
Actively perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
Respect documentation strategy
HSE
Ensure compliance to HSE requirements and rules
Ensure the 3 green lights are scheduled and correctly organized/done
Who are you ?
Master's Degree
Minimum 10 years of experience within pharmaceutical companies and working on CAPEX large projects.
Dynamic person with strong value commitment & resilient Strong Process Technical expertise
Fluent in English is mandatory. French is highly desirable.
Good Knowledge of cGxP requirements
GEP – Good engineering practice expertise
Excellent communication skills (able to present to Management, Engineering office, User and others) and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
Team player, Rigorous, Accountable, Involved, Proactive.
Pragmatic to solve issues; solution oriented with a positive mindset
Autonomous, fully acting at own's initiative.
Broad 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.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Able to both take direction and mentor other team members
Able to translate customers’ needs in technical requirements
Open to travel to support UCB strategic international projects
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.
Our partner is looking for a Bioanalytical Scientist to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
You will lead the development and delivery of ADA immunogenicity assays and associated data sets in support of our biologics (NBE) and/or gene therapy pipeline.
Work within the bioanalytical teams to optimize experimental design, sample analysis, data interpretation and report generation.
Have an opportunity to support the delivery of other bioanalytical methods including, such as cell-based assays.
Who are you ?
Candidates should have at least a BSc and preferably an MSc or PhD in a biological discipline with 3 to 8 years of hands-on experience in Bioanalysis.
Extensive and proven experience in developing and validating assays to assess immunogenicity.
Demonstrate in-depth technical understanding of ligand binding assays, particularly on platforms like MSD (Gyrolab, ELISA), dealing with complex ADA assays.
Experience with assessing and/or overcoming Drug, Target interference, presence of Preexisting ADA, characterization of multi-domain specificity in immunogenicity assays.
Ensure adherence to quality standards while supporting the delivery of assays and critical data sets within project deadlines.
Ability to generate, analyze, interpret, and present critical data sets.
An ability to work in a matrix and communicate clearly.
Be agile and flexible in adapting to changing projects and organizational priorities, aligned with project deadlines and departmental needs.
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.
Our partner is looking for a Supply Network Planner – Drug Product & Devices to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Production MPS Planning
To build and deliver a feasible MPS plan for one or several production nodes on the MPS time horizon (18M+) and PrO and PO hand over to production partners
To use the UCB adopted Advanced planning tool – OMP+ and SAP – to build monthly/weekly MPS where applicable – based upon Anaplan input developed by E2E products planners
Ensure that production plans are in line with customer requirements, stock policies and E2E S&OP products planners plans
In charge the Distribution Replenishment plan (DRP) for managed products. Collaborate closely with Global distribution & logistics for managing day-to day operations.
Run the capacity reconciliation assessment, identify gaps, find solutions with partners, vendor teams or site local planners and escalate to S&OP level if required. Set in place ad hoc capacity review (S&OP) with production sites (CMO and internal)
To manage all transactional data into the system for his/her dedicated assets based plan calculated at tactical level
Control execution of the plan over the frozen and MPS horizon
Ensure that production plans are in line with previous production step availability
Manage potential changes of plans in the frozen horizon
To manage the supply risk on the short and mid term horizon in collaboration with markets, TPA PVU Supply, Vendors, QA and E2E product planners;
To create STO once stock is available and communicate with logistics
To plan & coordinate with production and schedulers all restamps, reworks, validations, maintenance stops and availability of batches under deviations.
To manage change controls linked to planning activities
To consolidate Inventory requirements (Projection, Provision & Destruction) and be main point of contact for different functions
Production nodes (CMO and internal sites) Supply Performances Management:
In charge of weekly supply performances monitoring and analysis on defined KPI’s definition (OTIF, ATP,..). Responsible to facilitate the supply performances discussion within the Vendor team and with partners.
In charge Root cause analysis (Measure, Analyze, Improve and Control), primary performances lead in the vendor teams.
Responsible for leading performances management into the Tier departmental structure and on-site if any
Production nodes (CMO) Capacity planning:
development of capacity/capabilities views for each production nodes, support to elaboration of future mutual supply agreement with CMO. Active participation to SIOP cycle (pre-SRM, SRM, IR), participation to capacity extension projects and initiatives with production nodes rep with the vendor team. Alignment on capacity assumptions SAP/OMP to E2E Product planner tactical scenario planning and decision
Escalation Resolution: lead escalated supply issues resolution on production nodes with support of the vendor team and the supply network lead. Is accountable to update stakeholders on supply impact, resolution, figures and will support issue resolution acceleration within vendor team and the production sites representatives (hot topics, hypercare,…)
Planning integration : integration of input to supply plans, scenario planning, feeding decision making, support supply issues resolution
Process & Systems enhancement: drive and provide inputs to supply center of excellence (SC CoE), global planning and global distribution to ensure right process and system governance execution and propose improvement initiatives when needed (planning, order fulfillment, forecasting, performances management, etc…)
Partnering: accountable for creating relationship and trusted collaboration channel with supply chain representative of production sites, improve and sustain ways-of-working according to guidance and Network management playbook. Participate actively to vendor teams meeting and OMR.
NPL & LCM : Master Data Readiness, Artwork readiness (labelling implementation), PO – MPS alignment, Readiness of DP batches for next step, Readiness of Devices for next step, Production sequence agreement, Confirmation of initial supply (volumes and delivery dates), Samples agreements – Launch (FG/DP/DS)
Digitalization & Innovation : support innovation & digitalization initiative in partnership with GSC teams (SC CoE), CMO network Steering co up to project execution start
Manage Network Change: Input to Business Case, Vendor supply agreement creation, Capacity model definition, Critical parts definition, CMO operating strategy alignment, Align CMO segment, Translate CMO segment requirements into operating choices
Risk Management & Escalation flow : accountable for ensuring governance of risk management governance for CDMO network of what is beyond operational short term risks (provide inputs, assessments, mitigation) for tier-1 up to key tier-2 or tier 3 suppliers.
Who are you ?
Minimum Level of Education Required – Bachelor’s Degree
Certification (Describe): APICS fundamentals
Background in pharma Operations and/or Planning experience. Technical skills in associated manufacturing process is a plus
Performances Driven
Systems skills in SAP/OMP (or fast learner)
Experience or willingness to the manufacturing operational environment
Stakeholder management, skills to influence
Able to manage Details and complexity
Clear in oral and written communication (English)
Analytical mindset, KPI and Result Driven
Demonstrated Planning and constraint management capabilities
Ability to learn fast within a complex environment
Rigorous person, able to go from High view to very detailed view
Ability to influence others at all level of the organization
Capable of challenging ideas and providing Feedback in a constructive way
Strong Team Player
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.
Our partner is looking for a Global Quality Lead Solutions Partner to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
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 readiness
Product metrics
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
Product Impact Assessment as required to support deviations and investigations.
Interface with Medical Information Team and prepare answers to their requests and questions related to the product in scope.
Additionally, the Global Quality Lead Support will represent the Global Quality Lead team when assigned to projects and initiatives.It can also include a support role for:
Product Quality Complaint Committee preparation and complaints oversight
Product recall and product escalation meeting preparation
Annual report (i.e., reporting of change controls to Health authorities…)
Yearly Biological Product Report
Reviewer and approver of Global Specification for the accountable products
Reviewer and approver of Master BoM (Bill of Materials)
Act as the backup of GQL as needed
Who are you ?
Minimum Level of Education Required – Bachelor’s Degree
Minimum of 5-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience with biotechnological and/or aseptic processes, GMP in Quality, Manufacturing, or Quality Control would be an asset.
Fluent and confident use of English language verbally and in reading & writing.
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to work autonomously for the assigned activities with limited supervision.
Must be skilled and experienced in operating across cultures and in a multi -cultural environment.
Must be able to independently analyze data and information to draw conclusions and make effective decisions.
Must have the ability and agility to adapt to different type of products, tasks and Quality Leads in a collaborative mindset.
Must be able to identify and suggest harmonization and synergies opportunities to improve ways of working across global products.
Must be able to deliver presentations or reports adapted to the audience.
Must possess good interpersonal, verbal, and written communication skills.
Must have ability to identify risks and propose corrective actions within areas of expertise.
Experience in GMP audits and inspections would be an advantage.
Project management skills would be an asset.
Experience in Data Integrity assessment would be an asset.
Understanding of CMC Regulatory requirements is a must
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.
Our partner is looking for a Veeva Vault QMS Business Administrator to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
work with the process owners and core business leads to streamline legacy quality processes using Veeva functionality and drive user efficiency.
work with the business to develop and document system & user requirements (process, data & reporting)
participate in configuration testing in different system environments (sandbox, development, and acceptance)
participate in the authoring of computerized system validation documentation
participate in user manuals and training material creation/revision
support Go live cutover plan
support users during hypercare period
support migration activities (from previous QMS system)
support change management and communication to SMEs and user community
Who are you ?
Minimum Level of Education Required – Bachelor’s Degree
Preferred Level of Education – Veeva Certification
Area of Specialization – Veeva Vault/Vault Quality Suite/ QMS
5 or more years of experience in administration or maintenance of Quality Management System (preferably in the biosciences or pharmaceutical industry).
Proficiency in GxP Pharmaceutical Regulations (EMA, FDA, ICH), including those specific to computerized systems.
Good knowledge of validation requirements for computerized systems in the pharmaceutical environment.
2+ year of Veeva Vault Quality Experience and particularly desirable is QMS experience
Proven experience in working in cross-functional projects.
Strong process improvement skills and orientation
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.
