header-image

Engineering & GMP Facilities Director


  • Ubicación: San Sebastián (España)
  • Sector: Farmacéutico y biotecnología
  • Vacantes: 1
  • Disciplina: Ingeniería
  • Modalidad de trabajo: Presencial

Viralgen Vector Core, S.L.U.

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world. We want to make gene therapy accessible to all who live with a genetic disease.

Descripción de la oferta

About the role

We are seeking an experienced and strategic Engineering & GMP Facilities Director to lead and oversee all engineering and technical service functions at our advanced gene therapy manufacturing facility. This role will be responsible for managing the departments of Engineering & Maintenance, Calibration & Qualification, Systems, and Technical Services, ensuring compliance with GMP and regulatory standards, driving operational excellence, and supporting business continuity and growth.

This is a key leadership role that requires a strong combination of technical expertise, team leadership, and strategic planning within a fast-paced, regulated biopharmaceutical environment.

Key Tasks:

1. Strategic Leadership & Team Management

  • Lead and develop multidisciplinary teams across Engineering, Maintenance, Calibration & Qualification, and Technical Systems, fostering a culture of continuous improvement, agility, and high engagement.
  • Ensure alignment with corporate strategy through effective communication, professional development, and talent management initiatives.

2. Engineering Operations & Facility Management

  • Oversee the design, implementation, and optimization of critical engineering systems (e.g., HVAC, utilities, electrical) to support GMP manufacturing and operational excellence.
  • Ensure that all facilities and services are safe, compliant, efficient, and aligned with regulatory requirements and business needs.
  • Define and execute the strategy for infrastructure reliability, preventive maintenance, and technical services.

3. Calibration, Qualification & Compliance

  • Establish and manage robust programs for calibration and qualification to ensure accuracy, consistency, and regulatory compliance of all systems and equipment.
  • Conduct risk assessments and maintain up-to-date documentation aligned with current GMP and global regulatory requirements.
  • Guarantee that all facilities maintain necessary permits and licenses and are inspection-ready at all times.

4. Budget & Project Oversight

  • Develop and control departmental and facilities-related budgets, ensuring effective use of resources in line with business objectives.
  • Lead engineering and construction projects, ensuring delivery within scope, budget, and timelines, while maintaining operational continuity.

5. Governance, Safety & Corporate Compliance

  • Serve as the primary point of contact and decision-maker for engineering and facility matters, representing the function within the organization.
  • Ensure adherence to Health & Safety standards and corporate compliance policies across all operations.
  • Collaborate with executive leadership to align technical operations with company-wide goals and support strategic decision-making.

Requisitos

Skills & Qualifications:

Must Have:

  • Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Industrial or related).
  • Minimum 10 years of experience in pharmaceutical/biotech industry, including 5+ in a leadership role.
  • Strong knowledge of GMP compliance, regulatory guidelines (EU/FDA), and technical standards.
  • Demonstrated experience in managing multidisciplinary teams and technical projects.
  • Proven ability to lead change, improve systems, and ensure reliability in complex facilities.
  • Fluent in English; excellent communication and leadership skills.
  • Excellent problem-solving and analytical skills, with a data-driven approach to decision-making.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively across functions.
  • Company values: Humility, Empathy, Responsibility, Commitment, Teamwork, and Effort.

Nice-to-Have:

  • Strong background in quality assurance and quality control principles for ensuring the highest standards of product quality and facility performance.
  • Experience in gene therapy or advanced therapy medicinal products (ATMPs).
  • Project Management certification or experience with capital project execution.
  • Familiarity with computerized maintenance and calibration management systems (e.g., CMMS, CCMS).
Posición cerrada

  • Ubicación: San Sebastián (España)
  • Sector: Farmacéutico y biotecnología
  • Vacantes: 1
  • Disciplina: Ingeniería
  • Modalidad de trabajo: Presencial