We are a Contract Development and Manufacturing Organization (CDMO) with over 20 biotech companies worldwide that have placed their trust in us. We develop and manufacture lentiviral vectors as a European leader working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including haematological and solid cancers, and rare diseases.
We are looking for you to be part of our Team!
We are looking for a Manufacturing Assistant to fill this key position reporting directly to the Team Leader of Document Management and Devices.
You will perform the necessary operations for the assembly of batch devices, in strict compliance with quality and safety requirements. In addition, you will support the production process by managing PPE, managing waste, assisting in cleaning, etc.
- Assemble the devices of the batches to be manufactured (development, engineering batches, GMPs) as well as others that may be necessary for specific tasks.
- Maintain stocks and expiry dates within the devices assembled in their section, requesting material for new assemblies if necessary.
- Respect the GMP quality regulations during all the manufacturing phases, as well as the biosafety and PRL safety regulations of the workplace, both in terms of clothing and PPE, as well as in the manipulations to be carried out.
- Fill in the necessary records for the development of the job and carrying out administrative tasks to support the process, for the correct development of the same.
- Report any incident related to the job (prevention and quality).
- Collaborate in the drafting of procedures, research, CAPAs, and all tasks that lead to the continuous improvement of the process.
- Perform auxiliary tasks to the batch manufacturing process (waste management, clothing management, PPE management, etc.).
- Collaborate in the training of new recruits.
- Collaborate in the tasks of external technicians, as well as in the implementation of new machines and processes.
- Be trained at the last level in the procedures that apply to their job.
- You have a Professional education degree related to the area of Pharmacy, Drug Manufacturing, Quality Control, Molecular Biology, Cellular Cultures, etc.
- We value if you have knowledge of GxP regulations.
- We value if you have previous experience in manufacturing in GMP environments.
- You have knowledge of cell culture and pharmaceutical manufacturing processes.
- You have manual dexterity.
- You are a detailed and meticulous person, very responsible and analytical.
- You are passionate about continuous learning and you like to solve problems.
- Team working skills.
- You work in an orderly and structured way.
- You are disciplined at work.
- You have good oral and written communication skills.
We offer you
- You will have continuous career development that will help you develop your talent throughout your entire professional career.
- You will participate in innovative projects in constant technological update.
- You will have a competitive salary according to your profile for this position.
- You will have a flexible timetable, with the support you need to conciliate and balance your personal and professional life.
- You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to go ahead in the cure of diseases.
- We will support you in your personal change process, if you come from another region and wish to come to live in Donostia-San Sebastián (accommodation, support in the job placement for members of your family unit, schooling,…).
- You will enjoy a professional work environment, which is really distinguished by our humanity and closeness. And where we take care of diversity and inclusion. Diverse viewpoints, your curiosity, bring diverse capabilities that strengthen our focus and fuel our growth.
- We are proud on offering equal opportunities and a close, welcoming environment. All people receive consideration for our vacant positions, without distinction of gender, age, race, religion, identity, sexual orientation, origin, disability or any other characteristic.