Bioproduction engineer

Important information : If you choose the accessible version of a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This module explores performance and compliance levers in bioproduction through Lean approaches, controlled maintenance, and Industry 4.0 tools, with a constant focus on quality and data integrity.It is based on the principles of the Lean House and draws on tools such as the 5S method, the PDCA cycle, Kaizen, Kanban, and Six Sigma approaches.Digital modalities : Activity 1: eLearning / Activity 2 : Serious Game 3D / Activity 3 : eLearningTarget audience :Newcomers (technicians, engineers, researchers, and managers) preparing to take up a position in bioproduction or wishing to update their knowledgeStudents and teachers seeking to discover the pharmaceutical industrial environment and the challenges associated with biopharmaceutical production.Support functions (maintenance, regulatory, Quality, HSE, supply chain, Lean, PMO, data) wishing to better understand the fundamentals of bioproduction professionsEmployees in commercial functions, market access, management or partners (suppliers, subcontractors, consultants, investors) not familiar with bioproduction but wishing to better understand the ecosystem and challenges of bioproductionEvaluation procedure :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules

This module introduces the fundamental principles of technology transfer in bioproduction, outlining the key stages, stakeholder roles, and success factors involved in transferring a process from a development site to a manufacturing site.It relies on structuring tools such as GARAMP (Gap Assessment, Risk Assessment and Mitigation Plan), the preparation steps of the receiving unit, validation and comparability principles, as well as a modeling of the overall transfer process, including gap assessment, risk analysis, and the corresponding remediation plan.Digital modalities : Activity 1: eLearning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D / Activity 4: Serious Game 2DTarget audience : Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.Evaluation procedures :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one ( 80% of correct answers required).

This module presents the technological innovations that are transforming bioproduction processes, highlighting key levers for optimizing performance, quality, and industrial flexibility.It focuses on critical elements such as improvements in raw material composition, process intensification through the use of innovative chromatographic membranes, miniaturization, the integration of single-use equipment, and the digitalization of facilities to automate and enhance the reliability of production.Modalités digitales : Activité 1 : eLearning / Activité2 : eLearning  / Activité 3 : eLearningTarget audience : Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.Evaluation procedures :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one ( 80% of correct answers required).

Important information : If you choose the accessible version of a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This module immerses the learner in the operational management of a bioproduction unit operating under cGMP conditions, integrating quality requirements, Health, Safety and Environment (HSE) constraints, and the practical handling of safety and quality deviations.It is grounded in Good Manufacturing Practices (GMP/cGMPs), HSE principles, problem-solving methodologies (such as the 5M diagram and the 5 Whys method), and covers the complete deviation management process—from identification and criticality assessment, to root cause investigation, and the implementation of Corrective and Preventive Actions (CAPA).Digital modalities : Activity 1: eLearning / Activity 2:  Serious Game 3D / Activity 3: Serious Game 3DTarget audience : Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.Evaluation procedures :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one ( 80% of correct answers required).

Important information: If you choose the accessible version of a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This immersive module places participants in regulatory inspection scenarios to analyze real-life cases of data integrity deviations across various departments of a pharmaceutical organization.It is based on realistic inspection situations (Audit Trail review, user access management, uncontrolled paper forms, data entry errors, line clearance), the types of observations encountered (critical, major, minor), expected behaviors during an inspection, and the documentation requirements to respond appropriately to findings.Digital modalities : Activity 1 Part 1: eLearning / Activity 1 Part 2: Serious Game 3D / Activity 2: Serious Game 3D / Activity 3: Serious Game 3DTarget audience : Employees in the pharmaceutical, chemical, or biotechnology industries preparing to take up a position in Quality Assurance (QA) (operational, systems, or validation) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academia wishing to understand quality-related challenges in the industrial environment.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)