**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 based 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 a **Senior Validation Technician**, reporting to the Head of Quality Assurance – Manufacturing. **Your mission will be to ensure the integrity and compliance of validation activities according to GMP regulations and VIVEbiotech's internal standards.** Likewise, you will **collaborate with the Operations team to evaluate process changes and deviations that could impact compliance with the validation status**, designing necessary actions to ensure maintenance and proper validation status. ### **Your responsibilities** * You will contribute to the design and implementation of validation projects strategy. * You will review and approve validations according to the defined strategy and established validation plans. Likewise, you will review and approve validation protocols, final reports, and raw data supporting the information contained therein. * You will coordinate with different departments the execution of validation protocols. * You will apply Risk Management throughout each validation stage. * You will report significant activities and incidents to your direct supervisor and Operations managers, proposing solutions contributing to continuous improvement in validation management. * You will also collaborate with Operations teams to assess process changes and deviations that may impact compliance with validation status, designing necessary actions to ensure maintenance and correct validation status. * You will coordinate the management of incidents and deviations arising during validations, ensuring they are handled and closed in accordance with the Quality System. * You will review deviations and change controls associated with processes, evaluating their impact on validation status through appropriate Risk Assessments and proposing strategies to ensure compliance. * You will propose strategies for improvement and optimization of production processes, for which you must have an in-depth understanding of VIVEbiotech's lentiviral vector production process. * You will establish internal links with adjacent departments within the company to ensure smooth project progress. * Similarly, whenever required by the department, you will provide support to the Manufacturing QA area in managing the Quality Management System: * You will collaborate with your direct supervisor in developing and implementing the annual management plan for your area of responsibility, always with a cost-effectiveness continuous improvement vision impacting overall company enhancement. * You will report significant activities and incidents to your direct supervisor, proposing solutions driving continuous improvement in your area. * You will take on a leadership role in promoting VIVE culture both within and outside your team: behavioral values and teamwork, customer orientation, and continuous improvement in quality, safety, and environment. ### **What we value in you** **We are looking for someone with:** * Degree in Pharmacy, Biotechnology, Biology, Biochemistry, or related fields, complemented with knowledge in Regulatory Compliance (GMP, etc.). * Experience in Process Validation. * Expert knowledge of Good Manufacturing Practices (GMP) according to EMA and FDA standards. * Previous experience in the pharmaceutical industry in similar roles, with GMP certification. * Experience in the pharmaceutical industry in similar roles with GMP Part IV certification (GMP Guidelines specific to Advanced Therapy Medicinal Products), Annex I Sterile Medicinal Products Manufacture, and experience in environments regulated under FDA requirements. * Experience in root cause analysis and risk management. * Experience using computerized systems applied to the pharmaceutical industry. * Quality orientation, with a strong sense of excellence and self-discipline, working in an organized and methodical manner. * Proactive contribution with continuous improvement ideas, offering your knowledge and experience to help achieve departmental goals. * Ability to work effectively, proactively, and collaboratively within a team. * Responsibility and meticulousness in work, maintaining high performance under demanding results and deadlines. * Consistently positive attitude towards change. * Residing in Gipuzkoa or willingness to relocate to the area will be positively valued. ### **We offer you** * You will have continuous career development opportunities that will help you grow your talent throughout your professional journey. * You will participate in innovative projects undergoing constant technological updates. * You will receive a competitive salary commensurate 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 (accommodation, 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 are proud to offer equal opportunities. All individuals receive equal consideration for our open positions, without regard to gender, age, race, religion, identity, sexual orientation, origin, disability, or any other characteristic.