**About us** ------------------ We are an industrial company **leading internationally in the field of biotechnology and advanced therapies, based in Donostia\-San Sebastián, with a major expansion project, an unwavering passion for science, and a commitment to excellence and people.** Our **purpose:** improving people's lives through revolutionary advances in biotechnology and gene therapy that cure rare diseases and cancers. With a philosophy of not only working together but growing together, our client's culture is built on honesty, excellence, leadership, engagement, ethics, and rigor. We are a **CDMO** (Contract Development and Manufacturing Organization) and **the trust placed in us by more than 40 biotech companies worldwide is our best endorsement.** We develop and manufacture viral vectors (lentiviral), being one of the European leaders operating in accordance with EMA and FDA regulations. Lentiviruses produced by VIVEbiotech are used for treating various diseases including hematological and solid cancers, or rare diseases. **We are looking for you to join our Team!** ### **Your role** We are seeking an **Operational Quality Technician (GMP)** to fill this key position reporting directly to the GMP Team Leader. Your **mission** will be to keep the **GMP documentation of the Production Area continuously up to date.** Similarly, you will **participate in investigating incidents during the manufacturing process and propose corrective and/or improvement actions** for processes in cooperation with the Production team and the Quality Assurance Department. ### **Your responsibilities** * Keep current all GMP documentation of the Production area derived from the company's Quality Management System. * Receive GMP batch deviations and incidents from different types of batches to carry out the relevant investigations. * Conduct self-inspections in the Production Area, preparing status reports and improvement proposals. * Stay constantly and proactively updated regarding changes in existing production processes within the company. * Prepare change controls for the section, whether arising from incidents or continuous improvement, and coordinate internally (if cross-departmental). * Proactively participate in the investigation of manufacturing incidents, proposing corrective and/or improvement actions for processes, in cooperation with the Production team and the Quality Assurance Department. * Draft and update required SOPs for the section, and inform/train personnel on SOP changes to schedule corresponding training sessions. * Participate in the preparation of External Audits when necessary. * Coordinate with the Quality Assurance Department to implement new quality policies in the section. ### **What we value in you** You are who we are looking for if: * You have studies related to Biotechnology, Biology, 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 person oriented toward high quality (excellence and self-demand), organized and detail-oriented. * You proactively provide ideas for continuous improvement and share your knowledge and experience to help achieve your section's objectives. * You have the ability to work effectively within a team and are proactive. * You are responsible and rigorous in your work, demonstrating strong work capacity under high performance demands and tight deadlines. * You consistently show a positive attitude toward change. * Residency in Gipuzkoa (or intention to relocate to the area) will be positively valued. ### **What we offer** * You will have access to continuous career development that will help you grow your talent throughout your professional journey. * You will participate in innovative projects with constant technological updates. * You will receive a competitive salary aligned with your profile for this position. * You will benefit from flexible working hours, with the support needed to balance your personal and professional life. * You will become part of an expert, young, dynamic, innovative, and enthusiastic team united by a common purpose: supporting our clients in advancing cures for diseases. * We will support your personal relocation process if you come from another region and wish to move to Donostia\-San Sebastián (housing, job placement for family members, school enrollment, etc.). * You will enjoy a professional work environment truly distinguished by our humanity and closeness, where we care about diversity and inclusion. Diverse perspectives and your curiosity bring varied capabilities that strengthen our approach and drive our growth. * We take pride in offering equal opportunities. All individuals receive equal consideration for our open positions, regardless of gender, age, race, religion, identity, sexual orientation, origin, disability, or any other characteristic.