Dans le cadre de sa croissance, Just Evotec Biologics EU recherche un technicien spécialisé en Electrotechnique et Instrumentation pour participer au maintien des installations électriques CFo, CFa, VDI et d’une partie du parc biomédical, de manière à assurer leur plus grande disponibilité possible. Il réalise des opérations d’entretien et de dépannage courants dans son domaine de compétence et des petits travaux. Il s’assure du suivi de la maintenance préventive et corrective, via la maitrise de la GMAO MAXIMO d’une part, et des contrats de sous-traitance d’autre part.

Missions et activités:

Au titre de l'activité de maintenance

• Participe à la maintenance préventive et corrective des équipements du bâtiment (périmètre CFo, CFa, VDI) ainsi que des petites opérations sous-traitées

- Prend connaissance des contrats régissant son périmètre, et les engagements

- En cas de panne, sollicite les prestataires de maintenance contractuels

- Planifie toute intervention en liaison avec les responsables de service

- Accueille les prestataires

- S’assure de la présence si nécessaire des documents de sécurité

- Assure la traçabilité de leur intervention sur la GMAO et enregistre un bon de réception

• Exécute des opérations ponctuelles de manutention (petits déménagements).

- Prend en compte les demandes issues de la GMAO ou autre vecteur de demande.

- Prépare l’opération (véhicule, emballage, appareils de manutention...)

- Réalise l’opération, en respectant les contraintes d’hygiène et de sécurité.

• Exécute des petits travaux de second œuvre dans son périmètre

- Prend en compte les demandes issues de la GMAO ou autre vecteur de demande.

- Prépare l’opération (achat du matériel, validation préalable des plans, planification).

- Rédige un compte rendu/rapport d’intervention.

- Assure la clôture administrative de l’opération (GMAO, achat…)

• Assure la gestion de l’atelier, de l’outillage et des consommables.

• Alerte en cas d’anomalie sur l’utilisation anormale des locaux par les utilisateurs.

• Fait réaliser des devis, rédige et suit des demandes d’achat correspondantes (EVOBUY).

• Réalise des rondes régulières des points critiques des bâtiments de son périmètre (quotidienne, hebdomadaire, mensuelle) selon une procédure établie.

Au titre de la participation au service F&E

• Participe au dispositif d’astreinte technique

• Participe à la couverture horaire du service

• Participe à la mise en œuvre du système de management de la qualité dans son domaine d’activité et participe activement à son évolution

• Traite les anomalies issues des contrôles réglementaires bâtimentaires (via la GMAO) et participe activement à la sécurité de ses sites

• Participe à des opérations de rénovation et travaux neufs visant à réduire la consommation énergétique notamment (en lien avec son supérieur hiérarchique) :

Au titre de correspondant matériel

• A réception d’équipement neuf, s’assure que les opérations de qualification sont réalisées et enregistrées

• S'assure du respect des plannings de maintenance préventive

• Déclare sur MAXIMO les maintenances correctives

• Réalise, si besoin, des mesures ou des contrôles, en liaison avec le service calibration métrologie (tous capteurs environnementaux)

• Remet en service des équipements via la clôture des avis MAXIMO

Qualifications et attentes:

• Diplômé d'un BTS Electrotechnique ou BTS CIRA

• Au moins 5 d'expérience en électrotechnique et instrumentation idéalement dans un environnement GMP

• Maîtrise de l'utilisation et de l'administration du système de gestion de la maintenance assistée par ordinateur (GMAO)

• Capacité à gérer plusieurs tâches simultanément dans un environnement varié et dynamique

• Excellente communication (écrite et orale)

• Proactif (ve) et rigoureux (se)

• Idéalement à l'aise en anglais à l'écrit comme à l'oral

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Technicien Assurance Qualité Q&C– Equipements Analytiques

Just-Evotec Biologics recherche un Technicien QA Q&C – Equipements analytiques qui recherche une opportunité pour améliorer mondialement l’accès aux biothérapies.

Dans le cadre du projet de construction d’un site de fabrication de biomédicaments, rattaché au responsable Assurance Qualité Projets au sein du groupe Assurance Qualité Ingénierie et Validation, vous contribuez à l’application des Bonnes Pratiques de Fabrication au travers des processus de qualification des équipements.

A ce titre, vous serez amené.e à :

• Revoir la documentation rédigée par nos partenaires pour les équipements de nos trois laboratoires de contrôle qualité :

  • Laboratoire de microbiologie :

  • Laboratoire de Physico-Chimie

  • Laboratoire de Bioassay.

Les équipements dont vous aurez la charge seront adaptés à votre profil : Chaînes HPLC, Lecteur de plaques, Incubateurs, Pipettes, Congélateurs, Réfrigérateurs, Pompes de bioburden etc.

La documentation que vous reverrez seront : des protocoles de tests, des protocoles exécutés, des rapports, etc.

• Effectuer le suivi des déviations sur les équipements de votre secteur.

• Selon votre profil, vous pourrez être amené à suivre la mise en place de plan d’action ou de change control ou la revue de procédure.

• Assurer le reporting de votre périmètre auprès de votre supérieur hiérarchique

Formation / Profil

• Vous êtes titulaire d’un bac+2/3, orienté qualité ou laboratoire. Vous avez idéalement une expérience opérationnelle réussie (y compris stage ou alternance) en qualification.

• Vous connaissez les Bonnes Pratiques de Fabrication partie I & II, et particulièrement des annexes 1 et 15. 

• Une formation et/ou une expérience dans le domaine de la bioproduction est un atout.

• Vous êtes volontaire, dynamique, avez de bonnes qualités relationnelles et avez l’esprit d’équipe.

• Vous êtes à l’aise avec l’anglais à l’écrit. Ce serait un atout d’être à l’aise à l’oral.

Quality Assurance Q&C Technician – Analytical Equipments

Just-Evotec Biologics is seeking a motivated Quality Assurance Q&C Technician– Analytical Equipments that desires a significant opportunity to improve worldwide access to biotherapeutics.

As part of the project to build a biomedicines manufacturing site, reporting to the Project Quality Assurance Manager within the Quality Assurance Engineering and Validation group (QEV), you will contribute to the application of Good Manufacturing Practices through the equipment qualification.

As such, you will be required to:

• Review the documentation written by our partners for our 3 Quality Control Laboratories :

  • Microbiology Lab

  • Physico Chemistry Lab

  • Bioassay Lab

You will oversee several equipment according to your profile. Equipment can be : HPLC, COT metre; Incubators, Pipets, Freezer, refrigerator, bioburden pumps, etc.

The documentation to be reviewed are : protocols, executed protocols, reports, etc.

• Follow-up of deviations on equipment you have in charge.

• According to your profile, you can be involved in CAPA plan, Change Control and/ or SOP review.

• Reporting on your area of responsibility to your line manager.

Position Requirements

• You have a technical degree, preferably oriented quality, or laboratory. You have ideally a first successful operational experience (including sandwich course or internship) In qualification.

• You have a knowledge of Good Manufacturing Practices Part I & II and particularly appendix 1 and 15.

• Training and/or experience in biomanufacturing would be an asset.

• You are volunteer, dynamic with good relationship qualities and have a very good team spirit.

• You have a good writing English level. Having a good speaking English would be an asset.

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Technicien(ne) de laboratoire de contrôle qualité Physico-chimique

Dans le cadre de la mise en place d’une usine de production biotechnologique, et plus particulièrement de son laboratoire de contrôle qualité physico-chimique, Just-Evotec Biologics EU est à la recherche d’un(e) technicien(ne) de laboratoire spécialisé(e) en analyses physico-chimiques.

Vous rejoindrez une équipe en pleine expansion, multidisciplinaire et collaborative.  Sous l’autorité du responsable du laboratoire de contrôle qualité physico-chimique, vous assurerez le prélèvement des matières premières et l'analyse physico-chimique d'échantillons de matières premières, de contrôles en cours de fabrication et de produits finis.

Vous évoluerez dans un cadre règlementé par les Bonnes Pratiques de Fabrication sur notre nouveau site de Toulouse.

Principales responsabilités : 

• Réaliser le prélèvement de matières premières en zone à atmosphère contrôlée.

• Réaliser les analyses physicochimiques des matières premières, des produits intermédiaires et finis dans les délais et dans le respect des BPF et des règles HSE (HPLC, électrophorèse capillaire, analyses Ph. Eur. et USP, analyses spectroscopiques, …) .

• Collaborer avec le développement analytique pour assurer le transfert des méthodes conformément aux protocoles établis

• Assurer la traçabilité des enregistrements conformément aux BPF et aux principes d’intégrité des données.

• Rédiger / Assurer le maintien de la documentation qualité de son activité.

• Identifier les résultats hors spécifications, les écarts et les incidents de laboratoire et participer aux investigations.

• Veiller à la bonne tenue du laboratoire et notamment à la disponibilité des consommables, à l’entretien des équipements, au nettoyage de la verrerie, à la gestion des déchets, …

• Réaliser la qualification des équipements

• Vous pourrez être amené à assurer le maintien de la zone de prélèvement (classe C et D) et réaliser les prélèvements pour les contrôles d’environnement et contrôles particulaires selon les fréquences définies

Formation / compétences : 

• Bac + 2/3 en chimie analytique (DUT / BUT, BTS, ou équivalent)

• Minimum de 2 ans d'expérience au sein d’un laboratoire pharmaceutique.

• Bonne connaissance des référentiels pharmacopée européenne et américaine.

• Une expérience en zone à atmosphère contrôlée serait un plus.

• Anglais technique : lu, écrit. Anglais parlé serait un plus.

• Aisance avec un LIMS, et avec les applications Microsoft Office (Word, Excel)

• Esprit d’équipe, rigoureux(se), organisé(e), autonome, motivé(e) et enthousiaste

Physico-chemical quality control laboratory analyst

In the context of the establishment of a biotechnology production plant, and particularly its physico-chemical quality control laboratory, Just-Evotec Biologics EU is looking for a laboratory technician specialized in physicochemical analysis.

You will join a growing, multidisciplinary and collaborative team. Under the authority of the head of the physico-chemical quality control laboratory, you will ensure the sampling of raw materials and the physico-chemical analysis of samples of raw materials, in-process controls and finished products.

You will operate within Good Manufacturing Practices regulation on our new site in Toulouse.

Main responsibilities:

• Carry out the sampling of raw materials in a controlled atmosphere zone (clean room).

• Carry out physicochemical analysis of raw materials, intermediate and finished products on time and in compliance with GMP and EHS rules (HPLC, capillary electrophoresis, Ph. Eur. and USP analysis, spectroscopic analysis, etc.).

• Collaborate with Analytical Development to ensure method transfer in accordance with established protocols

• Ensure traceability of records in accordance with GMP and data integrity principles.

• Write / Ensure the maintenance of quality documentation for its activity.

• Identify out-of-specification results, deviations and laboratory incidents and participate in investigations.

• Ensure that the laboratory is maintained in good order, and particularly the availability of consumables, the maintenance of equipment, the cleaning of glassware, waste management, etc.

• Carry out equipment qualification

• You may be required to ensure the maintenance of the sampling zone (class C and D) and take samples for environmental controls and particle controls according to the defined frequencies.

Training/skills:

• Bac + 2/3 in analytical chemistry (DUT / BUT, BTS, or equivalent)

• Minimum of 2 years of experience in a pharmaceutical laboratory.

• Good knowledge of European and American pharmacopoeia standards.

• Experience in a controlled atmosphere area would be an advantage.

• Technical English: read, write. Spoken English would be an advantage.

• French: fluent

• Comfortable with a LIMS, and with Microsoft Office applications (Word, Excel)

• Team spirit, rigorous, organized, autonomous, motivated and enthusiastic

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Coordinateur de la libération des matières premières

Dans le cadre de la mise en place d’une usine de production biotechnologique, Just-Evotec Biologics recherche un coordinateur de la libération des matières premières.

Vous rejoindrez une équipe en pleine expansion, multidisciplinaire et collaborative.  Sous l’autorité du responsable Assurance Qualité Contrôle Qualité (AQ-CQ) au sein du groupe Assurance Qualité Process, vous assurerez la libération des matières premières pour utilisation en production.

Vous évoluerez dans un cadre règlementé par les Bonnes Pratiques de Fabrication sur notre nouveau site de Toulouse.

Principales responsabilités : 

• Vérifier la conformité et réaliser la libération de toutes les matières premières pour utilisation en production dans les délais impartis.

• Collaborer étroitement avec l’équipe de contrôle de la qualité pour

  • Garantir la conformité aux réglementations GMP, aux politiques de l’entreprise et aux normes en vigueur

  • Examiner/vérifier la documentation en rapport avec le prélèvement et le contrôle qualité des matières premières, y compris les méthodes d’essais, les procédures opérationnelles et les données analytiques.

  • Traiter les problèmes de qualité, les déviations et les non-conformités (OOS, OOT) en rapport avec les matières premières en veillant à ce qu'ils soient résolus dans les délais impartis.

  • Définir et surveiller les CAPA et les Change Control en rapport avec les matières premières.

  • Assurer la traçabilité des enregistrements conformément aux BPF et aux principes d’intégrité des données.

• Collaborer étroitement avec l’équipe d’assurance qualité fournisseur pour :

  • Garantir la conformité des matières premières avant libération pour utilisation en production 

  • Participer à la revue et l’approbation de la documentation fournisseur et des spécifications des matières premières, ainsi qu’au traitement des plaintes fournisseurs si nécessaire.

• S'assurer que toutes les activités liées à la libération des matières premières sont documentées avec précision et réalisées dans le strict respect des exigences réglementaires ; Assurer le maintien de la documentation qualité liée à l’activité en tant que rédacteur, vérificateur ou approbateur.

• Participer à la réalisation des analyses de récurrence et de tendance relatives aux activités de libération des matières premières ; maintenir les indicateurs de performances à jour.

• Favoriser une culture de la qualité, de la conformité et de l'amélioration continue au sein de l'équipe AQ-CQ.

• Assurer le reporting de votre périmètre auprès de votre supérieur hiérarchique

Vous pourriez également être impliqué(e) en collaboration avec les principaux responsables, dans les activités suivantes :

• Veilles réglementaire (Pharmacopées)

• Inspections (FDA, ANSM, etc), audits internes ou auto-inspections.

Formation / compétences : 

• Bac + 2/3 avec une spécialisation en assurance qualité dans l’industrie pharmaceutique

• Idéalement une première expérience réussie dans une industrie pharmaceutique

• Vous disposez d’une bonne connaissance des bonnes pratiques de fabrication.

• Une formation et/ou expérience avec l’utilisation d’un ERP ainsi qu’un LIMS serait un réel atout pour le poste.

• Une formation et/ou une expérience dans le domaine de la bioproduction est un atout.

• Bonne maitrise des applications Microsoft Office (Word, Excel, PowerPoint, OneNote)

• Vous êtes reconnu(e) pour vos qualités relationnelles, d’écoute et pour votre esprit d’équipe. Vous aimez le challenge, êtes motivé(e) et enthousiaste.

• Vous disposez de très bonnes capacités d’analyse, d’organisation et de synthèse, vous avez une bonne capacité d’adaptation.

• Vous avez un niveau d’anglais (lu, écrit) vous permettant de comprendre et écrire des documents. Un bon niveau d’Anglais à l’oral est également appréciable.

Raw material release officer

As part of the implementation of a biotechnology production plant, Just-Evotec Biologics is looking for a Raw material release officer.

You will be joining an expanding, multidisciplinary and collaborative team.  Reporting to the QA/QC Manager in the Process Quality Assurance team, you will be responsible for the release of raw materials for use in manufacturing.

You will work in a regulatory environment governed by Good Manufacturing Practices in our new Toulouse site.

Key responsibilities:

• Verify the conformity and release all raw materials for manufacturing use within the given deadlines.

• Collaborate closely with the Quality Control team to:

  • Ensure compliance to GMP regulations, company policies, and applicable standards.

  • Review/verify quality control documentation related to raw material sampling and control, including test methods, operating procedures, and analytical data.

  • Handle quality problems, deviations, and non-conformities (OOS, OOT...) related to raw materials, ensuring that they are resolved within the required timeframe.

  • Define and monitor CAPAs and Change Controls related to raw materials

  • Ensure traceability of records in accordance with GMP and data integrity principles.

• Work closely with the Supplier Quality Assurance team to:

  • Ensure raw material compliance before release for production use

  • Participate in the review and approval of supplier documentation and raw material specifications, and in supplier complaint handling as required.

• Ensure that all activities related to the release of raw materials are accurately documented and carried out in strict compliance with regulatory requirements; Maintain quality documentation related to the activity as author, verifier, or approver.

• Participate in recurrence and trend analyses relating to raw materials release activities; maintain up-to-date key performance indicators.

• Foster a culture of quality, compliance and continuous improvement within the QA/QC team.

• Report on your scope of responsibility to your manager.

You may also be involved in the following activities, in collaboration with their main stakeholders

• Participate in regulatory watch (European Pharmacopoeia);

• Participate in inspections (FDA, ANSM, etc.), internal audits and self-inspections.

Qualifications:

• You have a technical degree, with a specialization in quality assurance in the pharmaceutical industry.

• Ideally a first successful experience in a pharmaceutical industry

• You have a good knowledge of Good Manufacturing Practices

• Training and/or experience with ERP and LIMS would be a real asset for the position.

• Training and/or experience in biomanufacturing would be an asset.

• Good skills in Microsoft Office applications (Word, Excel, PowerPoint, OneNote)

• You are recognized for your interpersonal and listening skills, and for your team spirit. You enjoy a challenge and are motivated and enthusiastic.

• You have excellent analytical, organizational, and summarizing skills, and are adaptable.

• You have a level of English (reading, writing) that enables you to understand and write documents. A good level of spoken English is also valuable.

• You are fluent in both written and spoken French.

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Technicien QA C&Q – Utilités

Just-Evotec Biologics recherche un Technicien QA C&Q Utilités qui recherche une opportunité pour améliorer mondialement l’accès aux biothérapies.

Dans le cadre du projet de construction d’un site de fabrication de biomédicaments, rattaché au Responsable Assurance Qualité Utilités et Assurance de Stérilité au sein du groupe Assurance Qualité Ingénierie et Validation, vous contribuez à l’application des Bonnes Pratiques de Fabrication au travers des processus de qualification des équipements et de validation des procédés.

A ce titre, vous serez amené.e à :

• Revoir la documentation rédigée par nos partenaires pour les utilités : magasin, eau pour préparation injectable, gaz, HVAC, etc.

Vous serez en charge de plusieurs équipements en fonction de votre profil.

La documentation que vous reverrez seront : des protocoles de tests, des protocoles exécutés, des rapports, etc.

• Participer aux analyses de risques afin de déterminer les plans de prélèvements.

• Effectuer le suivi des déviations sur les équipements de votre secteur.

• Selon votre profil, vous pourrez être amené à suivre la mise en place de plan d’action ou de change control ou la revue de procédure.

• Assurer le reporting de votre périmètre auprès de votre supérieur hiérarchique

Formation / Profil :

• Vous êtes titulaire d’un bac+2/3, orienté qualité ou microbiologie. Vous avez idéalement une expérience opérationnelle réussie (y compris stage ou alternance) en qualification. Une expérience en qualification d’utilités propres est un atout.

• Vous connaissez les Bonnes Pratiques de Fabrication partie I & II, et particulièrement des annexes 1 et 15. 

• Une formation et/ou une expérience dans le domaine de la bioproduction est un atout.

• Vous êtes volontaire, dynamique, avez de bonnes qualités relationnelles et avez l’esprit d’équipe.

• Vous êtes à l’aise avec l’anglais à l’écrit. Ce serait un atout d’être à l’aise à l’oral.

Quality Assurance Q&C Technician– Utilities

Just-Evotec Biologics is seeking a motivated Quality Assurance Q&C Technician – Utilities that desires a significant opportunity to improve worldwide access to biotherapeutics.

As part of the project to build a biomedicines manufacturing site, reporting to the Project Quality Assurance Manager within the Quality Assurance Engineering and Validation group (QEV), you will contribute to the application of Good Manufacturing Practices through the equipment qualification.

As such, you will be required to:

• Review the documentation written by our partners for utilities : Water for Injection, warehouse, gases, HVAC, etc.

You will oversee several equipment according to your profile.

The documentation to be reviewed are : protocols, executed protocols, reports, etc.

• Follow-up of deviations on equipment you have in charge.

• According to your profile, you can be involved in CAPA plan, Change Control and/ or SOP review.

• Reporting on your area of responsibility to your line manager.

Position Requirements

• You have a technical degree, preferably oriented quality, or microbiology. You have ideally a first successful operational experience (including sandwich course or internship) In qualification.

• You have a knowledge of Good Manufacturing Practices Part I & II and particularly appendix 1 and 15.

• Training and/or experience in biomanufacturing would be an asset.

• You are volunteer, dynamic with good relationship qualities and have a very good team spirit.

• You have a good writing English level. Having a good speaking English would be an asset.

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Just-Evotec Biologics is seeking a motivated Materials & Warehouse Sr Manager that desires a significant opportunity to improve worldwide access to biotherapeutics.  As a leader, you will have the exciting opportunity to supervise the Materials Management team and coordinate the GMP warehouse activities for our Toulouse site. You will direct, supervise, and assign daily activities, transactions, and procedures for all components received, stored, kitted and shipped. In addition, you will develop, implement and maintain strict compliance of GMP policies and procedures for effectiveness and efficiency of strategic inventory and warehouse management initiatives while supporting effective manufacturing operations by leveraging supply chain tools including development of new and existing SOPs for material management processes. As a result, your understanding of enterprise resource planning and supply chain management will contribute to the continued success of Just Evotec Biologics

The Primary Job Responsibilities include:

• This position will provide strong leadership and technical expertise in inventory management control, GMP warehousing operations, pack out and shipping, and productive partner organizations interfacing for bill of materials management and materials planning

• Perform all work activities in a safe and compliant manner according to all Just. Biotherapeutics policies, procedures, and trainings.

• Coordinate and lead the warehouse day-to-day activities

• Using manual labor, pallet jacks, and forklifts, receive, identify, quarantine, store, handle, dispense, release, and issue raw materials, starting materials, intermediates, reagents, labels, GMP supplies and packaging materials to and from storage locations

• Weigh and dispense powder and liquid chemicals to support manufacturing operations

• Be responsible for maintaining an accurate inventory (physical and electronic), expiration, and retest records for all GMP materials, and traceability of all the warehouse movements.

• Access various business systems and input data with a high level of accuracy (i.e. decommissioning of materials, material destruction, plant to plant movements, and other non-routine ERP transactions)

• Coordinate disposition of all expired materials and maintain applicable documentation.

• Participate in internal and external GMP inspections when needed

• Interface with a variety of departments when coordinating shipping and receiving.

• Assist with deviations, change control, and corrective / preventive actions within the established Quality management system

• Ability to create and revise standard operating (SOP) reverent to department processes

• Record creation, collection, and storage per corporate retention schedules

• Perform department related project activity that may include investigating, analyzing, formulating possible solutions, documenting processes, and communicating results

• Participate in annual budget planning

• Assorted additional duties as assigned.

Qualifications / Requirements :

• Bac +5 required  in Supply Chain or a related field and a minimum of 5 years’ XP in a managerial role within a biotechnology/pharmaceutical environment; or equivalent combination of education and experience.

• Extensive knowledge of GDPs, cGMPs, and regulatory requirements including 21 CFR Parts 11, 210 and 211, and ICH Q7

• APICS certification a plus

• Ability to follow detailed verbal and written instructions

• Good basic mathematical skills

• Proficiency with PC desktop applications and business operations software system, in particular Microsoft Excel, SAP S4HANA

• Ability to lead, coach, and influence in a highly cooperative and dynamic environment

• Strong organizational, communication and interpersonal skills

• Valid driver’s license with acceptable driving record (if applicable)

• Experience and proven abilities to analytically investigate and troubleshoot system issues and drive the implementation of solutions.

• Demonstrated ability to plan, prioritize, and execute work appropriately with minimal supervision

• Experience in Quality management systems working on deviations, change control, and corrective / preventive actions

• Experience in Lean methodologies

• Focus on process standardization, and process efficiency, applying best industry practices

• Experience with cell therapy manufacturing is preferred

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Just-Evotec Biologics is seeking a motivated Material Planner Sr Manager.

The primary focus of this job is to lead the demand management process by working closely with Manufacturing, Quality, Supply Chain and Business Teams to create materials demand requisitions for procurement for Just-Evotec Biologics facilities in Toulouse.

The primary job responsibilities include:

• Partner with Project Management, Quality and Supply Chain to identify and qualify new supplier or vendor and raw material requirements and specifications

• Forecast and maintain materials supply using demand planning tools

• Assess inventory volume against planning assumptions

• Minimize inventory while ensuring material availability

• Schedule the supply of materials/components to meet production requirements and minimum safety stock levels

• Day-to-day requisition management and management of deliveries, as required

• Understand and manage risks to minimize impact on production schedule

• Take follow up actions in relation to material shortages that affect production

• Implement all processes to agreed standards and targets and support continuous improvement initiatives and identify areas of improvement

• Utilize any Material Requirements Planning system (MRP) or IT system that is in place and ensure that data is accurate and up to date and resolve any issues as required

• Monitor the integrity of Bill of Materials (BOM) and manage inventory accuracy

• Monitor inventory levels against agreed target levels

• Support inventory checks to validate inventory accuracy

• Create regular statistical reports and analysis and update others in the organization

• Partner with Procurement on Return Materials Authorization (RMA) instances

Additional responsibilities:

• Generate and communicate supplier material delivery schedules and forecasts to ensure they reflect requirements and meet demands

• Support assessment and sourcing of suppliers in conjunction with members of the Procurement team

• Support Supply Chain Management & Procurement in negotiations to ensure demand for materials are met, if required.

• Resolve supplier concerns and evaluate supplier performance in conjunction with members of the Supply Chain Management team

Educational Requirements:

• Bac +5 required in Supply Chain with 5+ years’ experience in manufacturing operations including roles involved with materials planning and production scheduling in a cGMP manufacturing environment.

• APICS Certification

Qualification Requirements:

• Motivated, self-starter

• Strong interpersonal, team, oral and written communication skills are a must

• Significant experience working with ERP systems, specifically Materials Management, Supply Chain Management, Demand Planning, Inventory Management and Production Scheduling modules in a cGMP environment. SAP S/4HANA desirable.

• Implementation and validation of Computerized Materials Management System (CMMS) experience preferred

• Candidate must possess strong focus on quality and attention to detail

• Possess effective task/time management organizational skills

• Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

IT Operations Team Lead

PERMANENT POSITION

Responsible for leading the Applications Services team in maintaining production application environments. Additional responsibilities include Maintaining applications in the development and test environments for pre-release testing. Perform application administration monitoring services, reviewing system and application logs. Provide technical support including maintenance of installed applications software; implementing, configuring, and testing new product versions with end users; Interact with business users to troubleshoot installation and implementation issues.

Responsibilities:

• Support of Applications in accordance with JPOD SOPs and appropriate project specifications

• Perform application installations to include setup of users, setup and configuration of systems and other support tasks

• Perform troubleshooting of application problems with no supervision

• Provide assistance to the IT Development team when needed

• Perform reviews of installations and patches

• May be required to be on-call to support after hours issues as they arise

• Deep level of understanding of Information Technology applications

• Ability to determine and make improvements to applications and processes

• Must be able to complete individually incidents and service requests within defined SLA

• Responsible for pro-actively looking at ways to reduce number of support calls

• Ensure interfaces between systems are maintained

• Interact with Cross functional teams keeping them informed of status updates

• Assist in the review and hiring of new staff where appropriate

• Ensure incident analysis is completed on time

• Develop procedures and training documentation as required

To be successful in the role, you will ideally have:

• Experience managing IT Applications/IT Support for a large organization - Pharmaceutical/Clinical Research experience desirable but not essential

• Strong People skills and previous people management desirable

• Experience of working in Continuous Improvement environments

• Analytical mind with problem solving aptitude.

• Strong communication and presentation skills

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

IT/OT Infrastructure Cybersecurity Specialist 

PERMANENT CONTRACT

We are looking for an IT/OT Infrastructure Cybersecurity Specialist to join Just Evotec Biologics in Toulouse.

Description:

The IT/OT Infrastructure Cybersecurity Specialist will be responsible for day-to-day cybersecurity, network security, information security, and application security.

The Information Technology Security Specialist will also work with the IT team and business units to identify security risks and implement security policies and procedures to protect sensitive information.

The candidate must have deep understanding of Information technology (OT) /Operational Technology (OT) security, with a focus on safeguarding critical infrastructures.

The IT/OT Infrastructure Cybersecurity Specialist plays a key role in designing, implementing, and maintaining robust security measures to protect our organization's IT/OT environments.

The IT/OT Infrastructure Cybersecurity Specialist can:

• Follow execution projects, addressing technical specifications shared by the project engineering team;

• Work with IT/OT teams in new products security management and testing;

• Support the proposal team in the production of documentation on control systems cybersecurity measures that may be required during the bidding phase.

The successful candidate will have to deal directly with standardization processes, seeking always for new features and producing suitable instructions for the commissioning teams.

 Qualifications:

• Cybersecurity, Network Security, and Information Security skills

• Experience with application security

• Knowledge of IT security frameworks, such as ISO 27001.

• Familiarity with security tools, firewalls, IDS/IPS, and endpoint protection

• Experience with security incident response and threat hunting

• Excellent analytical, problem-solving, and decision-making skills

• Ability to work independently and remotely

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Just-Evotec Biologics is seeking a highly motivated Senior Process Engineer Downstream - New Product Introduction (NPI) to join a fast-paced, collaborative, and multidisciplinary team to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional leadership for all phases of Just-Evotec’s NPI process – stretching from project initiation through process validation and registration activities. 

The role will require close collaboration with all functional areas of the J.POD Toulouse team – including Product and Process Design, Process Engineering, Process Automation, Facilities Engineering, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, Digital and EHS. The role will participate in client facing meetings to discuss topics related to NPI activities. The role will also collaborate with Just-Evotec Global MSAT, Client Program Managers, Global Supply Chain for client projects and continuous improvement efforts.

Responsibilities

• Reporting to the MSAT-NPI manager
• Lead Downstream stakeholders NPI process at J.POD Toulouse to support the start and rapid scale-up of commercial GMP manufacturing activities.
• Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations.
• Partner with supply chain to support Downstream Bill of Material development and demand planning for new products.
• Partner with Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction.
• Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction.
• Partner with Quality, CQV and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
• Acting as a subject matter expert for regulatory and client inspection audits.
• Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to Downstream NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
• Apply Operational Excellence principles to lead continuous improvement in NPI activities.

Requirements:

• Ph.D. (or Masters) degree in relevant field or related program with 10+ (15+) years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading a New Product Introduction program for biopharmaceutical products (Technology Transfer).
• Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ, and commercial manufacturing.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
• Demonstrated leadership capabilities to build and mentor high-performing teams, drive change, and influence internal and external stakeholders
• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization

Additional Preferred Qualifications:

• Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
• Experience in leading risk assessment and risk management for pharmaceutical products and processes.  Experience in applying principles of Quality by Design.
• Experience in developing submission packages for pharmaceutical product registration  
• Experience in client relations and communications.
• Demonstrated success in leading multi-disciplinary teams that span multiple organizations
• Entrepreneurial drive to achieve business objectives.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Dans le cadre de la construction d’une usine de production biotechnologique, et plus particulièrement de son laboratoire de contrôle qualité microbiologie, Just-Evotec Biologics EU est à la recherche d’un(e) technicien(ne) de laboratoire spécialisé en microbiologie.

Vous rejoindrez une équipe en pleine expansion, multidisciplinaire et collaborative, afin d'assurer la collecte et l'analyse d'échantillons de surveillance environnementale es zones à atmosphère contrôlée et des réseaux d'eau à usage pharmaceutique, ainsi que l'analyse microbiologique de matières premières, de contrôles en cours de fabrication et des produits finis.

Vous évoluerez dans un cadre règlementé par les Bonnes Pratiques de Fabrication sur notre nouveau site de Toulouse.

Le(la) candidat(e) retenu(e) aura idéalement travaillé dans un laboratoire de microbiologie ou aura suivi une formation avancée de technicien de laboratoire en microbiologie.  Une expérience des environnements de production des médicaments injectables, et notamment de la surveillance environnementale, de l'échantillonnage et de l'analyse de l'eau est un atout.

Le(la) candidat(e) idéal(e) a le souci du détail, est organisé(e) dans son travail et travaille bien de manière autonome et en équipe.

Principales Responsabilités :

• Travailler avec les membres de l'équipe pour soutenir les opérations du laboratoire de contrôle qualité microbiologie.

• Surveillance de l'environnement des zones à atmosphère contrôlée

• Échantillonnage et analyse de l'eau (charge biologique, endotoxine, carbone organique total et conductivité)

• Essais de produits (charge biologique et endotoxines)

• Identification microbienne

• Essais de fertilité pour la qualification des milieux de culture microbiens

• Exécution des tests de validation des méthodes microbiologiques pour les nouveaux produits

• Veiller à la bonne tenue du laboratoire, notamment au travers de l’entretien de l'équipement

• Veiller a la disponibilité des consommables de laboratoire

• Veiller à ce que la documentation soit complétée conformément aux bonnes pratiques

Vous pourrez également être amené(é) à participer à la validation des équipements (IQ, OQ, PQ)

Qualifications requises :

• Licence en microbiologie, biologie ou dans un domaine connexe et minimum de 3 ans d'expérience.

• Expérience ou formation technique en laboratoire de microbiologie

• Expérience de travail dans un laboratoire soumis aux BPF

• Expérience des applications Microsoft Office (Word, Excel)

Atouts :

- Expérience de l'échantillonnage et de l'analyse des eaux a usage pharmaceutique (charge biologique, endotoxine, COT et conductivité)

- Expérience de l'identification microbienne

- Formé(e) à l’utilisation de systèmes d’information de laboratoire (LIMS)

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.