Technical Services Engineer
About us
We are a Contract Development and Manufacturing Organization (CDMO) with over 40 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!
Your role
We are looking for a Technical Services Engineer to fill this key position reporting directly to the person in charge of Technical Services at VIVEbiotech.
In your role, you will help us to ensure that VIVEbiotech’s equipment and facilities comply with GMP process requirements, as well as to ensure that the rest of the company’s equipment and facilities are in optimal condition.
We value your knowledge of laboratory equipment and the biotechnology field and experience working in manufacturing clean rooms with GMP requirements.
Your responsibilities
- You will carry out preventive and corrective maintenance, calibrations and qualifications of equipment and facilities of the Company, managing the correct documentation of all activities.
- You will ensure compliance with GMP quality standards during all activities related to maintenance/calibrations and qualifications on work clothes, PPE, handling, etc.
- You will give support in the new projects of acquisition or implementation of new equipment and you will collaborate in the training to the people that are necessary in every moment.
- You will collaborate in the drafting of procedures, investigations, CAPAs and all the tasks that lead to the continuous improvement of the processes of use and maintenance of equipment, reporting any incident of safety, quality, etc. You will collaborate in the training of new recruits.
- You will manage external personnel accessing the company’s facilities for maintenance, calibration and qualification of equipment and facilities.
- You will collaborate as a team, with internal or external personnel, in the resolution of any type of breakdown or incident of the production equipment and auxiliary plant services.
- You will collaborate with your direct manager in the development and implementation of the annual management plan for your area of responsibility always with a vision of continuous improvement cost / effectiveness that affects the improvement of the company.
- You will report to your direct responsible the activities and incidents highlighted proposing solutions that affect the continuous improvement of your area.
- You will assume a leadership role in promoting the VIVE culture inside and outside the team: values of behavior and teamwork, customer orientation and continuous improvement in quality, safety and environment.
About you
- You have a university degree in Engineering or related to the world of Biotechnology or related sciences, complemented by a Master’s degree in Biomedical Engineering.
- You have knowledge or complementary training in Good Manufacturing Practices: EMA and FDA and training in Biotech processes.
- We value knowledge of calibration and qualification requirements for laboratory equipment and the biotech and pharmaceutical field in GMP facilities.
- You have a minimum level of English B2 (First Certificate of English).
- We value experience working in manufacturing clean rooms in GMP environments.
- You like to work to achieve team objectives and you are proactive, leading the achievement of results and with a cooperative attitude.
- You are customer oriented both internally and externally, reporting incidents, proposing solutions to problems and ideas for improvement.
- You are a person oriented to high quality (excellence and self-demanding), organized and orderly.
- You have good oral and written communication skills.
- You are a responsible and rigorous person in what you do, demonstrating a high capacity for work, when there is a high demand for results and dates.
- You like to work with a positive attitude towards change and you are flexible.
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.