Process Engineer
il y a 3 semaines
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
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.Requirements:
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.Additional Preferred Qualifications :
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.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.
-
Process Automation Engineer
il y a 1 semaine
Toulouse, Occitanie, France Evote Temps pleinProcess Automation Engineer – Data Historian (all genders) | Toulouse, FranceJust-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 Engineer will be part of the Process Engineering team in the Manufacturing Science...
-
Process Automation Engineer M/F/D
il y a 7 jours
Toulouse, Occitanie, France Evote Temps pleinThe Process Automation Engineer will be part of the Process Engineering team in the Manufacturing Science and Technology (MSAT) department. The incumbent will serve as the site-level lead for the configuration, implementation, validation, and lifecycle management of the site Process Automation System (PAS) for use in clinical and commercial manufacturing at...
-
Senior Automation Engineer Process Design
il y a 1 semaine
Toulouse, Occitanie, France Evote Temps pleinSenior Automation Engineer, Process Design (all genders)| Toulouse, FranceJust 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 collaborative and multidisciplinary scientific team within the Process Design group to...
-
Process Automation Engineer– Process Automation System
il y a 4 semaines
Toulouse, France Just Evotec Biologics EU 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 Engineer will be part of the Process Engineering team in the Manufacturing...
-
Process Automation Engineer– Process Automation System
il y a 3 semaines
Toulouse, France Just Evotec Biologics EU 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 Engineer will be part of the Process Engineering team in the Manufacturing...
-
Senior Automation Engineer Process Design
Il y a 2 mois
Toulouse, France Evotec 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 collaborative and multidisciplinary scientific team within the Process Design...
-
Process Automation Engineer
il y a 4 semaines
Toulouse, France Just Evotec Biologics EU 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 Engineer will be part of the Process Engineering team in the Manufacturing...
-
Process Automation Engineer
il y a 3 semaines
Toulouse, France Just Evotec Biologics EU 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 Engineer will be part of the Process Engineering team in the Manufacturing...
-
Process Engineer
Il y a 2 mois
Toulouse, France Evotec 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 manufacturing facility. The role will provide cross-functional interactions for all...
-
Process Engineer
il y a 3 semaines
Toulouse, France Just Evotec Biologics EU 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 manufacturing facility. The role will provide cross-functional interactions for all...
-
ALT 2024 Apprenti(e) Process Performance Engineer
Il y a 2 mois
Toulouse, France airbus 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 intitulée « Apprenti(e) Process Performance Engineer (h/f) » vient de...
-
ALT 2024 Apprenti(e) Process Performance Engineer
il y a 3 semaines
Toulouse, France airbus 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 intitulée « Apprenti(e) Process Performance Engineer (h/f) » vient de...
-
ATR-Processes, Methods and tools Engineer
il y a 1 mois
Toulouse, France airbus 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 of Competences and transversals departments of the ATR Engineering, the team’s...
-
ATR-Processes, Methods and tools Engineer
il y a 3 semaines
Toulouse, France airbus 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 of Competences and transversals departments of the ATR Engineering, the team’s...
-
Alt 2024 Apprenti Process Performance Engineer H/F
il y a 1 semaine
Toulouse, Occitanie, France Airbus Temps pleinde l'emploi :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 intitulée « Apprenti(e) Process Performance Engineer (h/f) » vient de s'ouvrir au...
-
Alt 2024 Apprenti Process Performance Engineer H/F
il y a 4 semaines
TOULOUSE, France Airbus Temps pleinDescription de l'emploi :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 intitulée « Apprenti(e) Process Performance Engineer (h/f)...
-
Senior Space Systems Engineer
il y a 1 semaine
Toulouse, France Darwin Recruitment Temps pleinDarwin Recruitment are currently hiring for a Senior Space Systems Engineer on behalf of a company in Toulouse that was founded in 2018 that are a leading provider of end-to-end earth observation camera solutions supplier for the global small satellite and CubeSats market. The senior Systems Engineer will be the lead technical interface to customers for...
-
Senior Mechanical Engineer
Il y a 2 mois
Toulouse, France ARCA Resourcing Temps pleinMechanical Engineer / Senior Product Design Engineer ️Toulouse Competitive salary and a robust benefits packageEmbark on a ground-breaking journey with a NewSpace leader based in Toulouse, dedicated to revolutionising in-orbit services. As a Mechanical Engineer, you’ll play a pivotal role in deploying advanced satellite technologies that challenge the...
-
Senior Mechanical Engineer
Il y a 2 mois
Toulouse, Haute-Garonne, France ARCA Resourcing Temps pleinMechanical Engineer / Senior Product Design Engineer ️Toulouse Competitive salary and a robust benefits packageEmbark on a ground-breaking journey with a NewSpace leader based in Toulouse, dedicated to revolutionising in-orbit services. As a Mechanical Engineer, you’ll play a pivotal role in deploying advanced satellite technologies that challenge the...
-
Senior Mechanical Engineer
il y a 3 semaines
Toulouse, France ARCA Temps pleinMechanical Engineer / Senior Product Design Engineer ️ Toulouse Competitive salary and a robust benefits packageEmbark on a ground-breaking journey with a NewSpace leader based in Toulouse, dedicated to revolutionising in-orbit services. As a Mechanical Engineer, you’ll play a pivotal role in deploying advanced satellite technologies that challenge the...
