- Reporting to the MSAT-NPI manager
- Contribute to leading 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 Process 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 to support the team for regulatory and client inspection audits.
- Utilize the team's technical skills and process knowledge to participate in 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.
- Masters degree in relevant field or related program with 5-10 years of pharmaceutical/biotech validation experience including a minimum of 2 years of experience leading a New Product Introduction program for biopharmaceutical products (Technology Transfer).
- Experience with late-stage clinical and/or commercial biologics drug substance manufacturing programs, including process validation, PPQ, and potentially commercial manufacturing.
- Proven record of accomplishment in GMP pharmaceutical or biotechnology is required.
- Strong background and technical mastery of purification and solution preparation operations using disposable-based manufacturing technologies.
- Leadership capabilities to contribute to building of a high-performing teams, to drive change, and influence internal and external stakeholders.
- 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.
- Good verbal and written communication skills in French and English; ability to interface with all levels of the organization.
- Experience in audits and inspections by health authorities and other external auditors as an audit support staff.
- Familiar with 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.
- Ability to lead multi-disciplinary teams that span multiple organizations.
-
Mfg. & Process Engineer
il y a 4 jours
Capgemini Toulouse, FranceShort Description · Job Responsibilities · De parcours ingénieur ou équivalent (Bac + 5) en mécanique ou production industrielle avec une appétence pour les procédés de fabrication, vous disposez dune première expérience réussie sur des missions orientées vers lindustrialisat ...
-
Mfg. & Process Engineer
il y a 21 heures
Capgemini Toulouse, FranceShort Description · Job Responsibilities · De parcours ingénieur ou équivalent (Bac + 5) en mécanique ou production industrielle avec une appétence pour les procédés de fabrication, vous disposez d'une première expérience réussie sur des missions orientées vers l'industrialisatio ...
-
Process Engineer
il y a 4 jours
Evotec Toulouse, France À temps pleinJust-Evotec Biologics is seeking a highly motivated Upstream Process Engineer - 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 manu ...
-
ALT 2024 Apprenti(e) Process Performance Engineer
il y a 5 jours
airbus Toulouse, France À temps pleinJob Description: · Envie de déployer vos ailes ? Et si votre aventure commençait avec nous ? · Nous vous proposons de travailler dans une entreprise leader mondial dans son domaine, tournée vers le digital, à la pointe de la recherche et de l'innovation. · Une offre d'apprentis ...
-
Senior Process Engineer
il y a 1 semaine
Worley Cologne, France À temps pleinGemeinsam sind unsere Mitarbeiter und Mitarbeiterinnen in 49 Ländern Vorreiter bei vielen Technologien und Innovationen unserer Branche. Aber die größte Herausforderung hat gerade erst begonnen. · Die Energiewende verändert die von uns genutzten Energieressourcen. Dies ist eine e ...
-
Process Automation Engineer
il y a 4 jours
Evotec Toulouse, France À temps pleinProcess Automation Engineer – Data Historian (all genders) | Toulouse, France · Just-Evotec Biologics is seeking a motivated and creative Process Automation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The Process Automation Eng ...
-
Team Leader Process Performance Engineer H/F
il y a 5 jours
Expleo Toulouse, France CDIMission · Rattaché au Responsable du pôle Manufacturing sur l'activité aéronautique, le/la Team Leader H/F est le premier relais managérial des collaborateurs travaillant sur son activité et l'interface privilégié de son/ses client(s). · Il/elle encadre et pilote son environnemen ...
-
Process Automation Engineer– Process Automation System
il y a 4 jours
Evotec Toulouse, France À temps pleinProcess Automation Engineer – Process Automation System (PAS) (all genders) | Toulouse, France · Just-Evotec Biologics is seeking a motivated Process Automation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The Process Automation ...
-
Process Engineer Level I
il y a 6 jours
Worley Cologne, France À temps pleinGemeinsam sind unsere Mitarbeiter und Mitarbeiterinnen in 49 Ländern Vorreiter bei vielen Technologien und Innovationen unserer Branche. Aber die größte Herausforderung hat gerade erst begonnen. Die Energiewende verändert die von uns genutzten Energieressourcen. Dies ist eine ein ...
-
ATR-Processes, Methods and tools Engineer
il y a 1 semaine
airbus Toulouse, France À temps pleinJob Description: · Within the ATR 's Engineering Directorate, the applicant will join the Processes Methods and Tools team. · She/he will be part of the team in charge of the governance of Operational Processes in terms of Methods and Tools. In relation with the technical Center ...
-
Senior Automation Engineer Process Design
il y a 1 semaine
Evotec Toulouse, France À temps pleinSenior Automation Engineer, Process Design (all genders) | Toulouse, France · Just Evotec Biologics is seeking a motivated and creative Senior Scientist or Engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. This position will join a co ...
-
Process Engineer F/H
il y a 4 jours
Safran Electrical & Power Villemur-sur-Tarn, France Permanent - À temps pleinJob Description · • Etre responsable de la définition et de la mise à jour des environnements industriels et intégration des standards industriels dans la suite PDM. · • Définir et appliquer les paramètres d'industrialisation, différentiel et règles de traçabilité dans la suite ...
-
Software, Navigation and Data Processing Segment Engineer
il y a 1 semaine
ESA Toulouse, FranceVacancy in the Directorate of Navigation. · ESA is an equal opportunity employer, committed to achieving diversity within the workforce and creating an inclusive working environment. We therefore we welcome applications from all qualified candidates irrespective of gender, sexual ...
-
ATR Toulouse, France StageSHIPJob Description: · Envie de rejoindre l'aventure ATR ? Une offre de stage vient de s'ouvrir sur notre site à St Martin · En 2023, ATR est labellisée Happy Trainees. 95.8% des étudiants recommandent notre entreprise à l'issue de leur alternance ou de leur stage. · Ce que nous ...
-
Apprenti(e) Ingénieur des Procédés
il y a 1 semaine
airbus Toulouse, France À temps pleinJob Description: · Envie de déployer vos ailes ? Et si votre aventure commençait avec nous ? · Nous vous proposons de travailler dans une entreprise leader mondial dans son domaine, tournée vers le digital, à la pointe de la recherche et de l'innovation. · Une offre d'apprentis ...
-
Technicien polyvalent
il y a 4 jours
Distribution Services Industriels Toulouse, France CDIDescription du poste · En nous rejoignant sur le poste de Technicien Polyvalent, vous intégrerez notre équipe DSI d'une centaine de collaborateurs sur le site d'un de nos clients, spécialisé en aéronautique. Intégré(e) à notre équipe, vous aurez pour mission, après avoir reçu le ...
-
Senior Mechanical Engineer
il y a 5 jours
ARCA Resourcing Toulouse, FranceMechanical Engineer / Senior Product Design Engineer · Toulouse · Competitive salary and a robust benefits package · Embark on a ground-breaking journey with a NewSpace leader based in Toulouse, dedicated to revolutionising in-orbit services. As a Mechanical Engineer, you'll pl ...
-
Magasiner Spécialiste GMP
il y a 6 jours
Evotec Toulouse, France À temps pleinDescription · du poste · • Réalise l'ensemble des tâches dans le respect des règles de sécurité et de qualité, suivant les politiques, procédures et formations de Just- Evotec. · • Utilisation des engins de manutention de l'entrepôt pour réceptionner, contrôler, étiqueter, stoc ...
-
ALT 2024
il y a 4 jours
airbus Toulouse, France À temps pleinJob Description:Envie de déployer vos ailes ? Et si votre aventure commençait avec nous ? · Nous vous proposons de travailler dans une entreprise leader mondial dans son domaine, tournée vers le digital, à la pointe de la recherche et de l'innovation. · Une offre d'apprentissage ...
-
Project Manager Chartering
il y a 3 jours
BOURBON SUBSEA SERVICES Toulouse, FranceBOURBON SUBSEA SERVICES is the BOURBON Business Unit dedicated to offshore subsea operations. · From vessel charter to turnkey projects, our team provide our clients with a full range of services to assist at every stage of the life of their oil and gas, and wind turbine fields, ...
Process Engineer - Toulouse, France - Evotec
Description
Just-Evotec Biologics is seeking a highly motivated Downstream Process Engineer - 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 interactions 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, 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
Requirements:
Additional Preferred Qualifications :
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.
Professionnels du métier de Process Engineer à Toulouse
-
Rashad Daou
MS Fluid Engineering for Industrial Processes
-
Yassine EL HAOUARI
Technical Project Manager