GID Technician
Lesuccès d'une entreprise passe avant tout par les hommes et femmes qui la composent...
Ensemble, partageons nos talents.
Ceva Santé Animale est la 1ère entreprise de santé animale française, et est classée au 5ème rang mondial.
Ensemble, c'est avec passion que les femmes et les hommes de Ceva recherchent, développent, produisent et commercialisent des solutions de santé innovantes pour soigner tous les animaux, et ainsi contribuer à la préservation des grands équilibres de notre planète.
Nous nous engageons à assurer le meilleur niveau de soins et de bien-être possible aux animaux d’élevage (volailles, porcs, ruminants), aux animaux de compagnie (chiens et chats) et à la faune sauvage.
En effet, notre vision « Ensemble, au-delà de la santé animale » met en avant le lien étroit qui existe entre la santé et le bien-être des personnes, des animaux et de notre planète. Ceva est plus que jamais engagé dans une approche « One Health », une seule santé en français.
Dans le cadre de notre politique "Diversité, équité et inclusion", Ceva Santé Animale s'engage en faveur de l'emploi des personnes en situation de handicap et déploie les moyens nécessaires au bon déroulement des entretiens de recrutement. N'hésitez pas à nous solliciter.
Vos missions :
In this role you will prepare working seed, assist in the industrial development, process, and product improvement of our Immucox vaccine.
Responsibilities Include
Working Seed (Approximately 85% of Role)
- Complete care of baby birds - health assessments, feed and water, record observations.
- Tray and cecal harvest.
- Transfer feces, purifying with both sieve and salt float/centrifuge.
- Coordinate with Management/Planning for date of harvests and species.
- Coordinate with hatchery to receive eggs on expected date - receive birds as they hatch.
- Cleaning of working seed bird rooms.
Industrialization Strategy Definition and Management
- Execute the manufacturing & testing according to the industrial development and process transfer rationales to anticipate industrial needs – may propose process validation strategy.
- Assist in the development of state-of-the-art, robust, and cost-effective biological production processes from laboratory to industrial scale including roller bottles, multi-plate cell culture systems, bioreactors, inactivation and downstream processing for new and existing products.
- Allowed to contribute to propose a validation strategy without associated means.
Batch Manufacturing Preparation
- Order, receive, & identify the materials and components.
- Participates in inventory management.
- Participate in technical feasibility at lab scale by performing experiments.
- Participates in industrialization process meetings.
Risk Assessment
- Provide inputs in risk analysis phase (manufacturing, EHS) and participate in risk assessment meetings.
- Follow relevant quality rules and sustain quality status where applicable.
Process Improvement
- Carry out the dedicated laboratory activities in process improvement according to the relevant rules.
- Provides inputs for concerned change control processes led by QA.
- Suggest the improvement of industrial lab practices.
- Assist in optimizing existing production processes.
Batch Manufacturing
- Ensure correct batch manufacturing execution and alert their superior if process parameters are incorrect during batch manufacturing; write batch manufacturing report.
- Ensure correct execution of sampling plan.
- Dispatch samples to the QC labs and summarize analytical results.
- Carry out the dedicated laboratory activities in technology transfer processes.
Training & Tech Transfer
- Provides the correct data to technology transfer reports and participates in writing technical transfer reports.
- Participates in designing/leading training sessions for production operators to explain product manufacturing process and critical requirements.
- Write process related study protocols, reports, SOP’s and manufacturing directions.
- Prepare summaries of test results for use in GID monthly summaries and/or reports.
Production & R&D Support
- Participate in the trails plan proposal and execution to be performed for change control activities (RM, process...).
Lab Management
- Ensure lab preventive maintenance & qualification and updates user guides/protocols for GID.
- Ensure that relevant quality standards and regulations are followed during activities.
- Define/complete studies and manage daily work according to priorities (including laboratory experiments, inventory management, data management, documentation/reporting, budget preparation and monitoring, CAPEX).
- Conduct laboratory work as assigned on viral, bacterial, parasitic, and/or recombinant vaccine projects.
Internal Audit & Inspection
- Update and write instructions and forms according to relevant quality standards.
- Provides inputs to answer internal/external audit & inspection queries.
Other duties as assigned.
Votre profil :
About You
- You have a BA/BS in microbiology, Biology, Chemistry/Pharmacology or Bio Engineering.
- You have previous experience working with lab animals.
- Ideally you have at least 2 years experience working with bioreactors in a production setting.
- You have an understanding of bioprocesses, fermentation, cell culture, and assays in research, production and/or manufacturing environment are preferred.
- You have basic knowledge of Pharma procedures and GMP procedures.
- You have good communication skills both verbal and written.
- You have the ability to interact within a group and cross-functional and collaborative teams.
- Ideally you have basic knowledge in microbiology and chemistry, tissue culture, and virus titration or prior virology experience.
- You shape solutions out of complexity and question the way things are done.
- You see the glass as half full and possess a can-do attitude.