GMP Technician

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 GMP Technician to fill this key position reporting directly to the GMP Team Leader.

Your mission will be to keep updated, at all times, the GMP documentation of the Production Area.

You will also participate in the investigation of incidents in the manufacturing process and propose corrective actions and/or process improvements in cooperation with the Production team and the Quality Assurance Department.

Your responsibilities

• Maintain up to date all GMP documentation of the Production area derived from the company’s Quality Management System.
• Receive deviations of GMP batches and incidents of different types of batches to carry out the relevant investigations.
• Perform self-inspections in the Production Area, making status reports and improvement proposals.
• To be updated, on his/her own initiative and in a constant way, in relation to the changes in the production processes existing in the company.
• To elaborate the changes controls of the section, whether they come from incidences or continuous improvement, and to coordinate internally (if they are multidepartmental).
• Participate proactively in the investigation of manufacturing incidents, proposing corrective actions and/or process improvements, in cooperation with the Production team and the Quality Assurance Department.
• Write and update section SOPs as required and report/train on changes in SOPs to schedule training of relevant personnel.
• Participate in the preparation of External Audits, when required.
• Coordinate with the Quality Assurance Department to implement new quality policies in the section.

About you

• You have studies related to Biotechnology, Pharmacy, etc. complemented with knowledge of Regulatory Compliance (GMP, etc.).
• You have at least one year of experience in the main functions described either in Quality Assurance or Production departments.
• You are a high quality oriented person (excellence and self-demanding), organized and orderly.
• You give ideas, proactively, of continuous improvement and offer your knowledge and experience, in order to collaborate in the achievement of the objectives of your section.
• You have the ability to work effectively within a team and you are proactive.
• 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 always show a positive attitude towards change.

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.