Validation Technician (Zamudio)

ABOUT US

We are dedicated to the research, development, manufacture, and distribution of allergen immunotherapy products, helping to improve the quality of life for patients worldwide through innovative healthcare solutions.

Our Technical, R&D, and Clinical Trials headquarters are located in Zamudio, which is also home to our manufacturing facility. As part of our ongoing growth and expansion plans, we are looking for talented professionals who are passionate about quality, innovation, and continuous improvement.

Our Values:

• People-Centric: We put people at the center of everything we do.
• Committed to Excellence: We foster individual accountability and high standards in pursuit of shared success.
• Curious and Innovative: We are constantly learning, innovating, and valuing the unique experiences and perspectives that each person brings to the organization.

ABOUT THE JOB

We are looking for a Validation Technician—Process, Cleaning, and Aseptic Process Validation —to join our Validation Unit in Zamudio on a permanent contract.

Reporting to the Validation Unit Manager, he or she will be responsible for coordinating, executing, and documenting validation activities related to manufacturing processes, cleaning validation, and aseptic process simulations (media fills), ensuring compliance with regulatory requirements, Good Manufacturing Practices (GMP), and internal quality standards.

Mission

Coordinate, execute, and document validation activities related to manufacturing processes, the cleaning of production equipment and facilities, and aseptic process simulations (media fills), in accordance with the planning and objectives established by the Validation Unit Manager, ensuring compliance with GMP requirements and internal procedures.

Main Tasks and Responsibilities

• Prepare, review, and maintain documentation related to:
  • Manufacturing process validations.
  • Cleaning validations of production equipment and facilities.
  • Aseptic process simulations (media fills).
  • Qualifications related to the processes being validated.
  This documentation will include risk assessments, validation plans and protocols, reports, procedures, validation matrices, the Validation Master Plan (VMP), and any other documentation required to support validation activities.
• Coordinate and carry out validation activities in collaboration with the relevant departments, ensuring that studies and tests are conducted in accordance with approved protocols, internal procedures, and applicable GMP requirements.
• Monitor the execution of validation studies, collect and evaluate results, and complete validation protocols, records, and reports, ensuring traceability, data integrity, and compliance with documentation standards.
• Evaluate validation results, identify potential nonconformities or deviations from predefined acceptance criteria, and establish and document the corresponding conclusions.
• Identify and document deviations that arise during validation activities, collaborate in investigations and root cause analyses, and participate in change control management and the definition and implementation of Corrective and Preventive Actions (CAPAs).
• Work across functions with Production, Quality Assurance, Quality Control, Microbiology, Engineering, and other relevant departments to ensure the effective planning and execution of validation activities.
• Participate, as required, in internal and external audits and regulatory inspections, as well as in the preparation of responses to deficiencies or regulatory observations related to validation activities.
• Contribute to the continuous improvement of processes and the validation system.
• Perform any other duties related to the position that may be assigned by the line manager or functional manager, in accordance with the applicable professional group.

Requirements

• A university degree in pharmacy, chemistry, biology, biotechnology, health sciences, or an equivalent scientific discipline.
• A master’s degree, postgraduate qualification, or specific training related to the pharmaceutical industry, validation, and/or GMP regulations, along with practical knowledge and application of Good Manufacturing Practices.
• At least 3 years of experience in the pharmaceutical industry, including hands-on experience in manufacturing process validation, cleaning validation of production equipment and facilities, and aseptic process simulations (media fills).
• Proven experience in the preparation and implementation of validation protocols and reports, risk assessments, and the evaluation of validation results.
• Experience in investigating and managing deviations, change controls, and CAPAs related to validation activities.
• Ability to coordinate validation activities across different departments and effectively monitor timelines and related actions.
• Advanced computer skills.
• Fluent in English, both written and spoken (C1 level).
• A strong attention to detail, analytical thinking, teamwork, and a proactive approach focused on continuous improvement.

Others

We are looking for a detail-oriented, organized, and results-driven professional with the ability to manage critical documentation and collaborate effectively across multiple departments. Strong communication and teamwork skills, analytical abilities, and a strong commitment to quality and regulatory compliance are essential for success in this role.