**About us** ------------------ We are an industrial **global leader 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, involvement, 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 to treat various diseases, including hematological and solid cancers, and rare diseases. **We're looking for you to join our Team!** ### **Your role** We are seeking an **Engineering Manager** whose mission will be to **plan and adapt the company’s facilities and general technical services to meet capacity growth objectives, quality improvement, and cost reduction** (services such as HVAC/compressed air/water plant/nitrogen tanks/gases, new warehouse, room expansions, space redefinition, etc.). ### **Your responsibilities** * Design the growth strategy for the company's facilities and general technical services according to its growth plan. * Coordinate and propose the annual equipment and facility investment plan for VIVE, aligning with process managers’ equipment needs. * Manage Facility Maintenance, as well as any related incidents. * Implement main production equipment (bioreactors, isolators, TFF units, biowelders…), and auxiliary plant services (autoclave, peroxidation system, particle counting system, WFI water loop…), including their receipt, integration into the quality system, qualification, and validation of their operation. * Support the Production Department in continuous improvement of process logistics. * Liaise with maintenance service providers and pharmaceutical equipment manufacturers to manage maintenance and calibration activities and assist in improving manufacturing processes. * Design, implement, and validate, where applicable, GMP facility maintenance and logistics protocols. * Collaborate with USP and DSP teams to provide necessary technical resources to ensure proper process development. * Draft technical and quality documentation such as: risk assessments, deviations, change controls, protocols, validation reports, data statistics, etc. * Work jointly with internal and external personnel to resolve any type of failure or incident related to plant auxiliary services. * Technically analyze innovative technologies available in the market and their potential implementation. * Adapt plant logistics procedures to current GMP regulations from the EMA and FDA standards. * Attend to and support external personnel entering VIVEbiotech facilities to perform maintenance, calibrations, and qualifications. ### **What we value in you** You are who we’re looking for if: * You have an Engineering background, complemented with knowledge of Regulatory Compliance (GMP, etc.) * You have at least 3 years of experience as Engineering Manager in similar environments within the industry. * You possess knowledge or additional training in Good Manufacturing Practices: EMA and FDA, and training in Biotechnological Processes. * Experience with calibration requirements and qualification of laboratory and biotech/pharmaceutical equipment in GMP facilities is valued. * You have a minimum B2 level in English. * You enjoy working towards team goals and show proactivity, leading results achievement with a cooperative attitude. * You work customer-oriented, both internally and externally, reporting incidents and proposing problem solutions and improvement ideas. * You are a person focused on high quality (excellence and self-demand), organized and detail-oriented. * You have strong oral and written communication skills. * You are responsible and rigorous in your work, demonstrating high work capacity under high performance demands and tight deadlines. * You like to work with a positive attitude toward change and are flexible. * Residency in Gipuzkoa (or intention to relocate to the area) will be positively considered. ### **What we offer** * You will have continuous career development opportunities 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 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.