ABOUT US
We are dedicated to the research, development, manufacture, and distribution of allergen immunotherapy products, helping improve the quality of life of patients worldwide through innovative healthcare solutions.
Our Technical, R&D, and Clinical Trials headquarters are located in Zamudio, which is also home to our current manufacturing facility. As part of our continued 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 continuously learn, innovate, and value the unique experience and perspectives each person brings to the organization.
ABOUT THE JOB
We are looking for a Validation Technician to join our team in Zamudio, temporary replacement position with a genuine opportunity for a permanent contract. Reporting to the Validation Unit Manager, he/she will be responsible for executing and coordinating assigned validation activities, ensuring compliance with regulatory requirements, Good Manufacturing Practices (GMP), and internal quality standards.
Mission
Implement and carry out validation activities related to manufacturing processes, aseptic processes, and cleaning validations, ensuring the proper execution of validation plans and contributing to the maintenance of the validated state of production processes through rigorous management of documentation, risk assessments, and associated deviations.
Main Tasks and Responsibilities
- Prepare, review, and maintain validation documentation, including risk assessments, validation plans, protocols, reports, Validation Master Plans, procedures, matrices, and any other documentation required for cleaning, manufacturing process, and aseptic process validations.
- Coordinate and execute validation activities, actively participating in the planning, monitoring, and performance of validation studies and tests, ensuring that all activities are carried out in accordance with internal procedures and applicable GMP requirements.
- Complete and review validation protocols, reports, and records, ensuring data integrity, information traceability, and compliance with quality standards and regulatory requirements.
- Identify, document, and investigate deviations arising during validation activities, collaborating in root cause analysis, change control management, and the implementation of Corrective and Preventive Actions (CAPAs).
- Work cross-functionally with different departments to ensure the successful execution of validation activities, minimizing operational impact and supporting the continuous improvement of processes.
- Participate in internal and external audits when required, as well as in the preparation of responses to quality and regulatory observations, in coordination with the relevant departments.
Requirements
- University Degree in Biosciences, Health Sciences, or a related discipline.
- Formal training in Pharmaceutical Industry Process Validation or a related field.
- Minimum of 3 years of experience in validation activities within the pharmaceutical, biotechnology, or other regulated industries.
- Strong knowledge of GMP regulations and applicable regulatory requirements.
- Advanced computer skills.
- Fluent English, both written and spoken (C1 level).
- 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, teamwork, analytical skills, and a high level of commitment to quality and regulatory compliance are essential for success in this role.
