Analyse and approve the master data’s requests (change requests on maintenance plans or spare parts/drawings,…)
Launch the investigations if necessary/share the feedback if necessary
Realise QA oversights (documentation/shopfloor)
Collect investigations data and analyse them in order to prepare a final investigation report (top chrono, check of the investigation )
Approve the maintenance work orders requests (ie.: technical modification requests) and participate to the meeting in link
Your profile ?
Navigation in SAP
GMP competencies
Risk based approach
Quality mindset.
Good interpersonal relationship skills
Good communication skills.
Good analytical skills; ability to investigate and ask questions, on the shopfloor.
Autonomous, Rigorous, Structured, Systematic.
Ability to work in team
University degree in Sciences (Bio Engineer, Biologist, Chemist,…)
SAP, good knowledge of outlook tools
Fluent in French, spoken and written; English is a plus
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. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Caroline, [email protected]
Pour notre client spécialisé dans le secteur bio-pharmaceutique, nous sommes à la recherche d'un Dessinateur Industriel – HVAC et Tôlerie. Le but est de concevoir de nouvelles solutions en traitement de l'air et HVAC pour des clients en Pharma et Biopharmaceutique.
Quelles sont vos responsabilités ?
Conception de pièces techniques (en inox…) pour le pharmaceutique
Proposition de solutions techniques
Préparation des documents de production
Rédaction de la documentation technique en collaboration avec les Opérateurs de Production
Participation aux activités du Département Qualité
Qui êtes-vous ?
Dessinateur technique en Electromécanique, Mécanique, ou équivalent
Expérience du secteur Bio-Pharmaceutique (production ou bureau d’étude)
Maîtrise des logiciels de dessin industriel (SolidWorks, Inventor et AutoCAD)
Connaissance des environnements mécaniques-techniques avec exigences de qualité basées sur l’ISO9001
Capacité d’intégration/travail en équipe/communication
Maîtrise des outils bureautiques
Connaissance des langues : Français, Anglais ; Néerlandais est un plus
Facteurs de différentiation :
Structure et organisation, auto-discipline
Haut niveau d’énergie et d’engagement
Que pouvez-vous espérer ?
Jefferson Wells vous offre plus qu'un emploi ou une carrière mais surtout l'opportunité de travailler sur des projets attractifs. C'est l'opportunité de participer au monde de demain ! Vous aurez l'occasion de toucher aux aspects très concrets, très techniques des projets mais aussi l'opportunité d'être créatif et de proposer des solutions innovantes !
Voulez-vous relever le défi ? Alors n'hésitez pas à postuler !
Pour notre client spécialisé dans la production d'injectable dans le milleu bio-pharmaceutique, nous sommes à la recherche d'un ingénieur de projet mécanique. En tant qu'ingénieur de projet, vous suivez différents chantiers de l’entreprise (conception, production, installation).
Votre mission
Suivi des chantiers de production et d’installation d’équipements
Gestion et entretien des contacts techniques et commerciales chez les clients
Rédaction des dossiers techniques des projets
Préparation des documents de production
Rédaction de la documentation technique en collaboration avec les Opérateurs de Production
Participation aux activités du Département Qualité : suivi des calibrations des instruments, des maintenances d’équipement, mise en place d’outils de gestion, etc.
Suivi de production
Contrôle Qualité des pièces produites
Contrôle Qualité des documents de production
Votre profil
Bachelier en Electromécanique, Mécanique ou Industriel
Expérience dans le secteur Bio-Pharmaceutique (production ou bureau d’étude)
Connaissance des environnements mécaniques-techniques avec exigences de qualité basées sur l’ISO9001
Expérience en people management
Capacité d’intégration/travail en équipe/communication
Maîtrise des outils bureautiques
Connaissance du français et de l'anglais
Notre offre Jefferson Wells vous offre plus qu'un emploi ou une carrière mais surtout l'opportunité de travailler sur des projets attractifs. C'est l'opportunité de participer au monde de demain ! Vous aurez l'occasion de toucher aux aspects très concrets, très techniques des projets mais aussi l'opportunité d'être créatif et de proposer des solutions innovantes !
Voulez-vous relever le défi ? Alors n'hésitez pas à postuler !
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 equipments and Aseptic technologies package.
Related to these packages, it includes :
Being company's representative for all Secondary equipments-related activities and installations
Supporting the E.O in management of activities related to this package
Ensuring alignment between E.O and the company 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
Profile:
Education :
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.
BA4 BT electrical certification granted by Employer
Hard skills
French / English
Demonstrates deep knowledge and expertise in design, implementation and qualification of engineering projects
Demonstrates deep knowledge and expertise in design, implementation and qualification of engineering projects.
Definition of functional, technical and quality requirements.
Realisation of reviews of process studies, P&ID’s and layouts
Oversight contractor's performance.
Integration of operability and EHS requirements at all design steps.
Preparation of the project testing, commisioning and inspection requirements
Organize legal conformity visits
On-site verification of execution according to good practices
Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…),..
Soft Skills
Team working & Communication / Autonomy / Contractors' management.
Good project integration experience: organisation, schedule, qualification, validation, technologies.
Experience in the Pharmaceutical industry
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.
Review/Approve the validation documentation regarding the GMP requirements and the GSK Vaccines procedures
Ensure that production practice are aligned with validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to Management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Work in autonomy with GSK supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
To support the production, QA and technical service teams in the implementation of the validation activities.
The skills and Knowledge Requirements
Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / Eudralex …
Knowledge of different regulations and GSK standards related to validation activities (VP, VSR, IOQ, VSR, PVR)
Knowledge of packaging activities
Knowledge of KNEAT (electronical validation system), MADB (Alarm management database), SAP
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.
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.
