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 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 – Process, Cleaning & Aseptic Process Validation to join our Validation Unit in Zamudio on a permanent contract.

Reporting to the Validation Unit Manager, he/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, 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 associated with the processes under validation.
- 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 execute validation activities in collaboration with the departments involved, ensuring that studies and tests are performed 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 non-conformities or deviations from predefined acceptance criteria, and establish and document the corresponding conclusions.
- Identify and document deviations arising 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 cross-functionally with Production, Quality Assurance, Quality Control, Microbiology, Engineering, and other relevant departments to ensure the effective planning and execution of validation activities.
- Participate, when 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 activities related to the position that may be assigned by the hierarchical or functional manager, in accordance with the applicable professional group.

Requirements

- University Degree in Pharmacy, Chemistry, Biology, Biotechnology, Health Sciences, or an equivalent scientific discipline.
- Master's degree, postgraduate qualification, or specific training related to the pharmaceutical industry, validation, and/or GMP regulations, together with practical knowledge and application of Good Manufacturing Practices.
- Minimum of 3 years of experience within the pharmaceutical industry, including hands-on experience in manufacturing process validation, cleaning validation of production equipment and facilities, and aseptic process simulations (media fills).
- Demonstrated experience in the preparation and execution of validation protocols and reports, risk assessments, and evaluation of validation results.
- Experience in the investigation and management of deviations, change controls, and CAPAs related to validation activities.
- Ability to coordinate validation activities across different departments and effectively monitor timelines and associated actions.
- 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.

📌 Validations Technician (Zamudio)
🏢 Roxall Medicina España
📍 Zamudio