Engineering Projects Head

We are a Contract Development and Manufacturing Organization (CDMO), based in Donostia-San Sebastián, currently undergoing a major growth project. We are driven by an unwavering passion for science and a strong commitment to excellence and people.

Our purpose: to improve people’s lives through groundbreaking advances in biotechnology and gene therapy that help cure rare diseases and cancer.

With a philosophy not just of working together, but growing together, our company 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 over 50 biotech companies around the world is our greatest endorsement. We develop and manufacture viral vectors (lentiviral), and are among the European leaders operating under EMA and FDA guidelines. The lentiviral vectors produced by VIVEbiotech are used in the treatment of various diseases, including hematologic and solid cancers, as well as rare diseases.

We are looking for you to be part of our Team!

We are looking for an Engineering Projects Head to perform this key role reporting directly to the company’s Chief Operating Officer.

Your mission will be to lead the planning, execution and delivery of strategic engineering projects at VIVEbiotech, initially focusing on the expansion of the company’s facilities, the increase in manufacturing capacity, the Good Manufacturing Practices (GMP) infrastructure and the capital investment program.

You will also act as a Senior Technical and Project Management Manager, ensuring that engineering projects are carried out safely, in accordance with regulations, within the planned deadlines and within approved budgets. You will also contribute to strengthening VIVEbiotech’s Engineering Operational Support (EOS) capabilities, project governance and long-term engineering standards.

• Manage the facility expansion and investment projects (CAPEX) assigned to you, from scope definition to design, contracting, construction, commissioning, approval, delivery, and project closure.
• Translate business and operational needs into clear project requirements, technical specifications, user requirements specifications (URS), budgets, schedules, resource plans, and execution strategies.
• Lead the technical evaluation, selection and coordination of engineering firms, equipment suppliers, contractors, consultants and qualification partners.
• Coordinate multidisciplinary project teams and ensure effective coordination between Operations, Quality, Environment, Health and Safety (EHS), Finance, Procurement, Process Development, Technical Transfer and other relevant functions.
• Ensure that project design and execution comply with applicable Good Manufacturing Practice (GMP), EHS, regulatory, quality, and internal company requirements.
• Lead equipment and facility implementation activities, including design reviews, factory acceptance testing (FAT), on-site acceptance testing (SAT), commissioning, qualification, operational readiness, and handover to the final owner of the system.
• Ensure that engineering documentation is complete, accurate, approved, and properly transferred to VIVEbiotech’s quality and asset management systems.
• Promote solid project governance, including control stages, decision records, risk records, action monitoring, change control and periodic progress reports.
• Provide support in engineering-related deviations, corrective and preventive actions (CAPA), change controls, investigations and technical risk assessments, providing practical and sustainable solutions.
• Provide high-level technical support to Manufacturing and other operational areas, especially as it relates to complex equipment, facilities, utilities, reliability, and capacity constraints.
• Contribute to asset lifecycle planning, facility master planning, engineering standards, and prioritization of future investment needs.
• Develop and standardise engineering project management processes, templates, procedures and working methods across the EOS function.

• You have at least 5 years of engineering experience in the pharmaceutical, biotechnology, CDMO, vaccine, or other highly regulated GMP environment.
• You demonstrate responsibility in the execution of relevant CAPEX projects, including facility expansion, new GMP areas, utilities, or large manufacturing equipment.
• You have hands-on experience managing multi-disciplinary engineering activities, external engineering partners, suppliers, contractors, budgets, schedules, and project risks.
• You demonstrate expertise in various phases of the project lifecycle, from requirements and design to commissioning, qualification, delivery and operational commissioning.
• You have a University Degree in Industrial, Mechanical, Chemical, Electrical, Biomedical Engineering or any other closely related discipline.
• Having related Master’s Degree Training will be positively valued.
• You have a solid knowledge of the principles of Good Manufacturing Practice (GMP) and their application to pharmaceutical or biotechnological facilities, utilities and equipment. Ability to propose potential process improvements.
• You have working knowledge of project management, investment management (CAPEX), technical documentation and risk management.
• Official training in project management or certification, such as PMP, PRINCE2 or equivalent, will be an asset.
• Likewise, training or demonstrated experience in commissioning and qualification, design of clean rooms and HVAC systems, process services, integration of safety, health and environment (EHS) in design, data integrity and computerised systems will be valued.
• You have at least a C1 level of English (C2 is an asset).
• High capacity for teamwork and orientation to results.
• Residence in Gipuzkoa (or intention to move to the area).

• You will have continuous career development that will help you develop your talent throughout your professional career.
• You will participate in innovative projects that are constantly updated technologically.
• You will have a competitive salary in line with your profile for this position.
• You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to advance in the cure of diseases.
• You will enjoy a professional work environment, which is truly distinguished by our humanity and closeness, and where we take care of diversity and inclusion. Diverse points of view, your curiosity, bring diverse 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.