Our partner is looking for a Project Manager Advanced to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
The consultant will have 2 “caps”: Project Management & SME Expert, will be involved in the validation of the new IT system.
Drive the integration plan of the Quality Systems and Processes, to ensure business continuity as well as compliance at any time
Drive the plan to implement the identified solution at global level
Assess any GxP Data Integrity risks related and ensure adequate mitigation plan are in place and followed-up on.
Ensures project team maintains focus on quality and continuous delivery
Drives the implementation of the integrated systems and processes encompassing the change management principles (ADKAR model, change management model, etc.)
Utilizes team feedback and metrics (quality, delivery rate, etc.) to track progresses of the changes and identify critical areas (in terms of resources, risks, impact, etc.)
Communicates with leaders across the organization on a regular basis to ensure transparency into delivery, risk, issues, etc.
Author, Review, and/or approve as appropriate any SOP, Change Control, Deviations, Investigation, CAPAs associated to the aforementioned activities and Data Integrity topics
Support audit/inspections as required
Who are you ?
Required language: English, other language not required.
Experience required: Data integrity, CVS (Computer System validation)
Experience in GxP Data Integrity in the pharmaceutical industry
IT knowledge required: Trackvise, Veeva, QALM (not mandatory but a +)
Strong organizational skills, excellent time management, excellent communication skills, good teamwork and team player
Homeworking: 40%
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 SME Infrastructure to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Represents infrastructure expertise across various construction projects, from civil engineering to completion.
Ensures the consolidation of project planning for both infrastructure and completion phases with the project leader and/or technical coordinator.
Establishes infrastructure and completion specifications.
Conducts, or revises as necessary, the infrastructure and completion study portion.
Monitors subcontractor implementation to ensure compliance with specifications.
Ensures subcontractor scheduling is maintained and communicates any deviations directly to the project leader.
Who are you ?
Minimum 5 years of experience required in an equivalent position.
Professional experience in a regulated environment (Pharmaceuticals, Nuclear, Agri-food) is a plus.
Industrial Engineer specializing in Construction; Civil Engineer.
French is a requirement, English is a plus (written comprehension is sufficient).
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.
About our client Our client is looking to strengthen their team within the Center of Excellence in Validation with the support of a Junior Validation Engineer.
Your responsibilities Within the center of excellence in validation at LMSAT the responsibilities will be:
Support the improvement program regarding filters and filtration management, participate in the documentation review, including validation plans, protocols, reports, and standard operating procedures (SOPs).
Perform gap assessment between different documents and between documents and practices in the field. Propose improvement and simplification following observations.
Using current procedure and state of the art knowledge, contribute to build educational materials on validation topics.
Collect data across different system to build a database related with validation activities.
For a given situation, use available data and statistical tools to calculate operational ranges and min or maximum values as needed.
Executing validation protocols for equipment, systems, and processes, documenting each step to provide a comprehensive record.
Collaborate closely with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure all activities are performed in accordance with current Good Manufacturing Practices (cGMP) and other relevant guidelines.
Stay updated with industry trends, regulatory updates, and technological advancements to contribute to the development of best practices and innovative validation methodologies within the pharmaceutical manufacturing.
Skills and knowledge requirements
You have a bachelor’s or master’s degree in science or equivalent by experience.
You have an experience with equipment and process validation in the pharmaceutical industry.
You have a good knowledge of GMP regulations.
You have a good knowledge of aseptic technologies and viral processes.
You like to work in a team and are quality oriented.
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]
Pour notre client spécialisé dans le ferrovaire, nous sommes à la recherche d'un technicien outillage
Quelles sont vos responsabilités ?
Concevoir et gérer les outillages spécifiques
Collaborer à l’analyse du design
Assurer le suivi de la fabrication et le suivi administratif de la commande
Réaliser la notice d’utilisation de l’outillage si nécessaire
Gestion de la maintenance des outillages en production
Gestion du stockage des outillages non utilisés
Gestion de la modélisation détaillée de l’outillage
Améliorer l’ergonomie et l’EHS aux postes de travail
Mettre en place des mesures de réduction des risques.
Participer aux demandes et à la mise en place des CAPEX (investissements) avec le responsable de service méthode.
Gérer les petits outillages portatifs
Collaborer avec le méthodiste pour établir la liste des petits outillages portatifs nécessaires au processus de fabrication et ce, dès le début de la conception d’un produit/projet
Superviser la mise en place des armoires outillages collectifs sur les postes de travail
Qui êtes-vous ?
Bachelier en électromécanique ou mécanique
Minimum 2 ans d'expérience en conception et/ou fabrication d'outillage
Maitrise de Catia V5
MS Office : niveau opérationnel
Anglais : niveau élémentaire (en lecture minimum) (A2)
Expérience bureau de conception mécanique outillage
Qualités d’adaptabilité, d’apprentissage de nouveaux procédés
Qualités de formateur (crédibilité technique, pédagogie adaptées aux ateliers)
Savoir faire des calculs simple de structure mécanique (via Excel)
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.
Vous êtes intéressé.e par ce poste? N'hésitez pas à postuler!
Pour notre client spécialisé dans les services facilities, nous sommes à la recherche d'un Facility Manager qui va travailler, soit sur le site de Mons (FR), soit sur le site de Bruxelles (FR/NDLS).
Quelles sont vos responsabilités ?
En tant que Facility Manager, vous êtes responsable de toute la communication et du suivi avec les clients, sous-traitants et fournisseurs.
Tâches et responsabilités :
Supervision quotidienne des services facilities chez les clients, y compris le personnel de nettoyage et les sous-traitants (techniques : HVAC, électrique, logistique, etc.).
Responsable de la formation du personnel afin qu'ils effectuent leur travail de manière correcte et sécurisée.
Gestion des matériaux et des ressources.
Contrôle des machines, des matériaux et des produits (fiches SDS, étiquettes, etc.).
Organisation de réunions de sensibilisation et d'autres formations pour les employés.
Gestion des urgences, des questions et des plaintes éventuelles, et proposition de solutions.
Contrôle de l'utilisation des équipements de protection individuelle (EPI).
Surveillance de la durabilité de nos services.
Réunions hebdomadaires et mensuelles avec le responsable du Facility Management.
Exécution des tâches administratives liées au poste, telles que l'approbation des horaires de travail et la planification.
Rendre compte au responsable du compte clé.
Qui êtes-vous ?
Diplôme de bachelier ou expérience équivalente, de préférence en gestion des installations.
Bonne connaissance du français et du néerlandais pour le site de Bruxelles. Pour le site de Mons, le néerlandais n'est pas essentiel.
Expérience en tant que responsable, coach ou ambition dans ce domaine.
Personne sociale et critique avec un souci de la qualité.
Axé sur le service envers l'entreprise, les employés et les clients.
Solides compétences organisationnelles et gestion efficace de l'agenda.
Charisme, pouvoir de conviction et bonnes compétences en communication.
Mobilité, flexibilité et autonomie.
Affinité technique avec l'électricité, l'électronique et le HVAC.
Bonne connaissance des programmes informatiques, notamment Outlook, Word et Excel.
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 partner is looking for a Senior validation engineer 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 C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
Establish and monitor validation KPIs.
Review handover of equipment / systems from suppliers and or other project stakeholders.
Who are you ?
More than 5 years of experience with PQ phase having led and managed validation projects, including sterile manufacturing.
Must have experience of working on projects; project management experience. We need someone who understands and knows what to do but not a PM expert.
Knowledge of safety, GMP and environmental regulatory requirements.
Expert in reviewing and writing technical reports.
EN is a must have
Ability to work with other persons – team spirit.
Homeworking : authorized, but must remain flexible according to project 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.
GMP compliance Our client Our client is looking for a profile in GMP Compliance to join its team. The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.
Your responsibilities – Release spare parts to be used on GMP equipment throughout the company plant. – Contact the spare parts' supplier in case of further investigation to allow release of the spare parts. – Ensure on the floor presence and be the point of contact for the operational team. – Participate to the strategy definition of the spare parts management and release. – Ensure the correct application of the quality systems on the field and to define improvement plan as required. – Process the backlog in release, investigations, and archives. – Challenge the new spare parts creations. – Review the modification proposed by the technical teams (MO). – Quickly understand the regulatory requirements for the spare parts – Use a risk-based approach for problem solving and prioritization of tasks – Blow a quality and compliance mindset through the operational team – Develop and continuously improve expertise linked to spare parts – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
Skills and knowledge requirements – University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) – At least 5 years professional experience in pharmaceutical environment. – Very good interpersonal relationship skills – To be a good team player in order to success in each validation project. – Fluent in French, good oral and written communication skills in English – Problem solving and achievement oriented – Knowledge of GMP Regulated environment – Strong organizational skills
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]
Vast Contract – Regio Gent #research #development #engineer
Beschik je over een bio-ingenieursdiploma met een specialisatie in de voeding? Heb je een passie voor voedselproductieprocessen en ben je gedreven om te zoeken naar optimalisatie en nieuwe producten? Ben je sterk communicatief, analytisch en leergierig? Lees dan vooral verder!
Onze partner is op zoek naar een R&D Project Engineer om hun R&D team te versterken. Dit sterk groeiend productiebedrijf gelegen in Gent is internationaal actief binnen de voedingssector.
Jouw verantwoordelijkheden?
Als R&D Project Engineer kom je terecht in een productieomgeving en krijg je de verantwoordelijkheid over het ontwikkelen en optimaliseren van bestaande en nieuwe producten en genereer je alle informatie met betrekking tot de nodige materialen, producten en processen in nauwe samenwerking met de productie en de kwaliteitsafdeling. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:
Voorbereiden, uitvoeren en evalueren van R&D projecten volgens de strategie van het bedrijf.
Technische ondersteuning bieden aan de Operations Managers en kwaliteitsafdeling.
Implementeren van verbeterings- en kostenminimalisatieplannen voor de productielijnen.
Voorbereiden en bewerken van het documentatiesysteem.
Definiëren van specificaties voor grondstoffen en andere materialen.
Definiëren van het proces en alle specificaties van de producten en volgt de wettelijke en bedrijfsrichtlijnen op.
Nauw samenwerken met diverse afdelingen (kwaliteit, productie, aankoop, etc.).
Ondersteuning bieden aan de R&D Manager.
Wie ben je?
Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als R&D Project Engineer over een diploma als bio-ingenieur met een specialisatie in voeding, eventueelaangevuld met ervaring in R&D of kwaliteit. Je hebt een passie voor voedselproductieprocessen en je bent gedreven om op zoek te gaan naar optimalisatie en nieuwe producten. Je bent communicatief vaardig in het Nederlands en Engels, Frans is een pluspunt. Daarnaast ben je sterk geïnteresseerd in het opvolgen van nieuwe trends en ben je teamgericht, zelfstandig en analytisch. Je bent zeer communicatief naar verschillende lagen in de organisatie. Tot slot kan je goed overweg met Excel en ben je bereid om sporadisch binnen Europa te reizen.
Wat kan je verwachten?
Als R&D Project Engineer kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.
Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Shauni Heyvaert op het nummer +32 (0)492 18 43 87 of via shauni.heyvaert(@)manpower.be.
Purpose of the Mission Engineering is primarily concerned with the installation and application of developed solutions, the maintenance of facilities, infrastructure, and equipment as well as the connection of services (water, chemicals, gases). Any other aspect in engineering like plant design, industrial programming, etc… may be concerned.
Primary Tasks & Responsibilities • Individually or as part of a project team responsible for solution design and process layouts for electricity and instrumentation equipment including the following installations: instrumentation and machinery for power generation, power supply, electrical protection, small cabling, calibration and measuring devices, Telecom equipment (data, Wifi, Deadman) and electrical distribution MT (36-11kV) and BT (400-230V-48V-24V). • Responsible for the execution, coordination and follow-up of solution designs and technical matters related to Process Control to ensure construction, transformation, commissioning, and qualification of the solution meets agreed cost, timing, technology, and quality standards in line with the Global Technical Services standards. • Key activities include: o Define functional, technical, and quality requirements. o Realize process studies, P&ID’s and process layouts whilst considering the operating and EHS characteristics at all design steps. o Ensure preparation and update of the project qualification and coordinate qualification activities of the installations. o Ensure work inspections are issued in line with quality standards. o Ensure systems legal conformity. o Coordinate technicians during execution to secure contracts and connection of services (water, chemicals, gases) and electricity.
Experience, Knowledge & Soft Skill Requirements • Demonstrates deep knowledge in design and implementation of engineering projects. • Practical experience in project supervision and people management • Perform his/her work in a cGMP consistent manner. • Experience in the Pharmaceutical industry
Soft Skills: • Good communication skills • Good project management skills: organization, cost, time, schedule, contracting, procurement, qualification, validation, technologies.
Education, Methodology & Certification Requirements • Industrial or Civil Engineer.
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 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.
