The process vision engineer will be a skilled professional that will work within the vision team, along with the other vision experts. In this position, he or she will be responsible to maintain and improve the automated visual inspection program as well as the robustness of other vision systems.
As a technical expert, he (or she) will also have to build and to manage technological knowledge for Automated Visual Inspection linked to manufacturing processes into the Production unit for syringes and/or vials. He (or she) will:
Assure proper functioning of Automatic Visual Inspection Machines in the Production unit.
Fine tune / develop new or existing vision programs to decrease false rejects or to improve detection capabilities.
Interact with production, Quality and global vision experts.
Lead and/or participate to technical investigations in case of atypical false rejects rate with the vision team, production supervision, Quality and maintenance team.
Provide vision expertise to support maintenance activities.
Develop technical knowledge in AVI with the support of local and global experts and supplier and supports field technicians as well as production performance.
Participate to the continuous improvement process performance (simplifies processes, design a short and mid-term strategy for the programable contents, lowers the false ejection rates)
Lead investigations and trials related to process improvement for vision (on the AVI machines and on the upstream process). Propose (and integrate) solutions for improvement.
Respects current Good Manufacturing Practices (CGMP) as well as GMP procedures.
Provides technical support to the deviation handling process (root causes identification and of CAPAs task execution in order to avoid recurrence of deviation with technical root causes).
Skills and Knowledge Requirements
Education : Industrial engineer (or similar level of education)
Knowledge : Automatic visual inspection, Vision systems (not necessarily linked to pharma), automated system programming.
Language : English and French.
Experience : 3-5 years' experiencein a similar function
Able to work in team in a production environment
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.
• Responsible for the coordination of the validation of small projects linked to eCC Secondary (Formulation or Filling) related to equipment such as freeze dryer, autoclaves, oven…or CIP, SIP, Mediabulk, Mediafill, Mediaform or utilities (EDI, EPI, EUF, VP, ACP, N2) or process control/automation equipment. • Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards. • Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects. • Review and approve protocols and certificates for IQ/OQ/PQ and check-lists. • Manage deviations and out of specifications: bring expertise and help in investigating and solving issues. • Ensure correct and state of the art Validation approaches for eCC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…) • Responsible for assuring inspection readiness – regarding Validation – by Corporate functions and RA authorities (FDE,EMEA,Canada). Make sure that drawings and core files are updated. • Has developed at least one area of expertise and is recognized as such. • Bring expertise and coaching to streams • Project Management: control/monitor cost and planning. Take corrective actions if necessary. • Ensure coordination with all key players (local QA, Global QA, • C&M, Streams rep…)
The skills and Knowledge Requirements
Must Haves: – University degree in sciences – Validation – Change control management – At least 5 years’ experience in Supply Chain activities (production, – QC, QA) in a global environment. – GMP knowledge – Knowledge of regulatory – Knowledge of Bio processes – Knowledge of Bio vaccines
Nice to haves: • Green belt or project management certification is an asset • Validation expertise • Change management • eCC expertise • P&P or similar experience/expertise.
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]
Qualification/validation process in a pharmaceutical environment
Minimum 3 years experiences in validation
Deviation handling
Flexible
Able to manage complexity
Ability to Keep it Simple
Organization, anticipation in planning
Communication in team / management
SAP
KNEAT
VEEVA
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]
In coordination with Engineering Office and Project Management, ensure correct design, construction, commissioning and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipment's and Aseptic technologies package.
Related to these packages, it includes :
Being the company representative for all Secondary equipment's-related activities and installations
Supporting the E.O in management of activities related to this package
Ensure regular technical contact with the manufacturing unit representative (User, QA, Validation, Maintenance,…)
Ensuring alignment between E.O and internal Specification and Guidance
Reviewing design and technical documentation
Following-up construction & all testing activities falling under the package’ scope
Ensure systems start-up and punchlist solving
Writing and executing commissioning and qualification protocols/reports
Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
Facilitating handover process towards the end user
Who are you ?
Engineering degree with 7 years experience as Process Engieer in Secondary Equipments, oriented Aspetic filling lines and Freeze-dried technologies, domains.
Strong Experience in the Pharmaceutical industry and cGMP environment.
Fluent in French and English
BA4 BT electrical certification granted
Team working & Communication / Autonomy / Contractors' management.
Good project integration experience: organisation, schedule, qualification, validation, technologies.
Perform his/her work in an EHS and cGMP high-demanding environment.
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.
Réalisation des expériences de laboratoire définies avec le responsable de projet
Manipulations en laboratoire afin de reproduire à petite échelle les étapes secondaire de production de nos vaccins : Media Preparation – Formulation – Filtration – Filling –Lyophilization en utilisant les techniques tel que : pH, Conductivité, Osmolarité, Viscosité, Turbiscan (vitesse de sedimentation), Néphélométrie, SLS et/ou DSL, Occhio, FTU units
Interprétation de la signification de ses résultats de manière assistée et conclusion scientifique
Rédaction d’un cahier de laboratoire de manière autonome et en respectant les procédures en place
Gestion du planning de vos manipulations
Parlons de vous !
Vous êtes en possession d’un Bachelier à orientation scientifique (Chimie, Biochimie, Biologie, …) ou d’un A2 (CESS) avec une expérience probante
Vous avez idéalement une première expérience en laboratoire dans un environnement pharmaceutique ou associé et vous avez les bases pour pouvoir manipuler sous flux laminare
Rigoureux(se), précis(e) dans vos tâches, vous avez l’esprit analytique et un bon sens critique
Vous savez travailler en équipe, êtes ouvert(e) au changement et à l’innovation.
Ce que nous pouvons vous offrir ?
Jefferson Wells te propose un contrat permanent en tant que consultant avec un package salarial attractif et te donne accès à des formations techniques et en compétences interpersonnelles. Nous serons ton partenaire de carrière à chaque étape du parcours.
Our partner is looking for an Validation Engineer to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
You will be responsible for managing and executing product transfers to Contract Manufacturing Organizations (CMOs) in the United States, particularly for secondary activities such as filling, visual inspection, and finished product packaging.
Responsibilities:
Assess the maturity and validation level of CMOs, including the analysis of differences in validation strategies.
Draft and review validation plans, including those of the CMO.
Write leveraging documents and difference analyses concerning the CMO's validation strategy.
Review and approve validation protocols and reports.
Verify validations included in the submission file and the CMO’s validation summary reports.
Provide technical support, maintenance, and troubleshooting at the CMO.
Who are you?
Convincing experience in the field of validation.
Strong communication skills and excellent proficiency in both French and English (project involving sites in the USA and Italy).
Ability to work in a matrix organization.
Experience with CMOs and in filling and visual inspection activities is a plus.
Previous experience at GSK is highly appreciated.
Skills and Assets:
Excellent communication and teamwork skills.
Perfect bilingual proficiency in English and French.
Ability to assess and analyze CMO validation strategies.
Aptitude for rigorously drafting and reviewing technical validation documents.
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.
The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.
The responsibilities – Release spare parts to be used on GMP equipment throughout 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 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]
Projets de revamping/modernisation d’équipements de packaging de vaccins
Projets d’installation de nouveaux équipements de packaging de vaccins
Tâches :
Etude préliminaire (layout, chemin d’introduction de l’équipement, impacts sur les machines amont/aval, impact validation, …)
Rédaction d’un URS afin de faire valider le projet/l’équipement au sein de la société et de permettre un appel d’offres vers différents fournisseurs présélectionnés
Organisation de la phase d’appel d’offres
Suivi des fournisseurs pendant les phases de préparation/préfabrication (technique et planning)
Si nouvel équipement : réception de l’équipement et de la documentation chez le fournisseur (FAT)
Analyse des besoins en termes d’alimentations électrique et pneumatique, connexion au réseau data
Organisation de ces connexions (fournir les data et propositions d’implantation au service électrique qui rédige les notes de calcul)
Gestion des master data SAP (nouvel équipement, suppression équipement, master data process control, …)
Participation à l’établissement des différents plannings (projet et microplanning) gérés par le PM
Définition et commande des équipements auxiliaires (convoyeurs, …)
Préparation de la validation
Gestion sécurité et technique du fournisseur durant la réalisation des travaux
Maitrise technique des modifications / du nouvel équipement via le suivi du commissioning
Tests de commissioning
Réalisation et documentation des tests IQOQ
Support utilisateurs et maintenance pour mise à jour de leurs documents
Formation des utilisateurs et maintenance (ou gestion de la formation si donnée par le fournisseur)
Transfert de la documentation technique vers maintenance
Suivi punchlist et Handovers
Gestion des CAPA et déviation associées au projet
Votre profil ?
Minimum 10 années d'expérience dans la gestion de projets techniques de packaging dans le secteur pharmaceutique
Maitrise de l'anglais et du français (parlé et écrit)
Compétence de base en automation
Accréditation BA5
Affinité avec la rédaction de documents de validation
Maitrise de MS Word et MS Excell
Compétences de base Techshare et SAP
Excellente capacité de communication et esprit de synthèse
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. Intéressé(e) ? N'attendez plus !
En tant qu'Analyste en Validation des Méthodes Analytiques Physico (PM AMR), vous jouerez un rôle crucial dans le département de remédiation des méthodes analytiques. Vous serez responsable de l'optimisation des méthodes analytiques existantes, en mettant particulièrement l'accent sur les techniques telles que les immuno-essais et ELISA, avec pour objectif de réduire l'utilisation de tests sur animaux au profit de tests sur cellules.
Responsabilités :
Connaissance des Méthodes Analytiques : Posséder une expertise approfondie dans les méthodes analytiques, avec une attention particulière portée aux techniques d'immuno-essais et ELISA.
Amélioration des Techniques de Laboratoire : Travailler activement sur le développement et l'amélioration des techniques de laboratoire, en mettant en œuvre des solutions innovantes pour réduire la dépendance aux tests sur animaux.
Suivi des Manipulations : Assurer un suivi rigoureux des manipulations de laboratoire, en garantissant la précision des procédures et en documentant les étapes de manière détaillée.
Analyse des Manipulations : Effectuer des analyses approfondies des manipulations effectuées, identifiant les opportunités d'amélioration et s'assurant de la conformité aux normes de qualité.
Gestion de Projet : Prendre en charge l'intégralité de projets, de leur conception à leur mise en œuvre, en assurant une gestion efficace des ressources et des délais.
Profil Recherché :
Ph.D. : De préférence, avoir un doctorat en sciences avec une spécialisation en méthodes analytiques ou domaine connexe.
Expérience en ELISA et Immuno-essais : Une expérience préalable significative dans les techniques d'ELISA et d'immuno-essais est essentielle.
Compétences en Gestion de Projet : Capable de gérer des projets de manière autonome, avec une attention particulière à la planification et à l'exécution.
Langues : Maîtrise de l'anglais requis pour une communication efficace au sein de l'équipe et des collaborations externes.
Département Remédiation de Méthode Analytique : Compréhension des enjeux liés à la remédiation des méthodes analytiques et volonté de contribuer à des projets innovants.
Adaptabilité et Créativité : Capacité à s'adapter à un environnement dynamique et à proposer des solutions créatives pour améliorer les méthodes existantes.
Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
The QA Validation is part of the QA Operations for one MPU. The QA Validation ensures the QA oversight of the continuous validation activities for one vaccine bulk production unit. Mains objectives of this function are:
To take part in the establishment, the implementation, the follow-up, and the maintenance of the continuous validation plan (CVP)
To define the validation strategies through the change control process (change control & MO notification) – Remark: No signature as task approver/stakeholders.
To write and implement some validation documentation (VP, VSR)
To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation review – Remark: No signature as final approver for equipment with high criticality.
To ensure the correct application of the validation quality systems on the field and to define improvement plan as required.
To support the production & technical services teams in the implementation of the validation activities
Your responsibilities The QA Primary Validation objective implies the following commitments:
To ensure an efficient and compliant CVP implementation
To provide a compliance and business expertise for some specific technical subjects
The responsibilities of the QA Primary Validation are among others:
Challenge, review and approve qualification and validation (IQ, OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the Vaccines standards and procedures.
Write some validation (VP, PQ, VSR)
Review & approve (not as final approver) Periodic Validation Review documentation according to the Bio standards and procedures.
Ensure timely escalation to Management of critical issues during validation and/or project.
Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
Attend all project meetings as QA expert from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics.
Skills and knowledge requirements The QA Primary Validation must be able to:
Quickly understand the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
Use a risk-based approach for problem solving and prioritization of tasks.
Blow a quality and compliance mindset through the validation activities.
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]
