Technical services head
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 Technical Services Head to fill a key position reporting directly to the Plant Operations Director.
You will manage the different activities related to the Equipment, Plant Services and Incidents related to these activities. You will develop the assigned projects with autonomy and initiative, in continuous alignment with the general strategy of the company, in terms of objectives and deadlines.
- You will manage the main production equipment (bioreactors, isolators, TFF units, biowelders…) and the auxiliary plant services (autoclave, peroxidation system, particle counting system, WFI water loop…), including their reception, introduction in the quality system, qualification and the validation of their operation.
- Yo will collaborate with the USP and DSP teams to ensure proper development of the processes.
- You will work together with the maintenance team in the management of any type of breakdown or incident in the production equipment and auxiliary plant services.
- You will design, implement and validate, where appropriate, logistics and plant maintenance protocols.
- You will write technical and quality documentation such as: risk analysis, deviations, change controls, protocols, validation reports, data statistics, etc.
- You will evaluate the impact of deviations and study and introduce new procedures for continuous improvement and automation of operations.
- You will adapt the logistics procedures of the plant and the equipment, to the current GMP regulations of the EMA and the FDA regulations.
- You will technically analyze innovative technologies in the market and their possible implementation.
- You will support the production department in the continuous improvement of the logistics of plant processes.
You are who we are looking for if you have:
- University Degree Studies in Biotechnology, Biomedical Engineering, Chemical Engineering, Process Engineering, Biochemistry, etc.
- 2-3 years of experience in similar activities, related to bioprocesses or equipment management, in technical services departments of biotechnology or biopharmaceutical companies.
- Knowledge of GMP regulations.
- High level of English and Spanish
- Solid orientation to high quality, rigor, excellence and self-demand.
- Ability to work under pressure for results and dates, and a positive attitude towards change.
- Capacity for autonomy, resolution, proactivity and continuous improvement
- Good oral and written comunications habilities
- And, above all, a vocation to learn and work because of the team and for the team.
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.