ABOUT US

We are dedicated to the research, development, manufacture and distribution of allergen immunotherapy products, contributing to improving the quality of life of patients around the world through innovative healthcare solutions.

Our Technical, R&D; and Clinical Trials headquarters are located in Zamudio, where our manufacturing plant is also located. As part of our growth and expansion plans, we are looking for talented professionals committed to quality, innovation and continuous improvement.

Our values:

- People-centred: We place people at the centre of everything we do.
- Committed to excellence: We promote individual responsibility and high standards of performance to achieve shared success.
- Curious and innovative: We continuously learn and innovate, valuing the experience and unique perspectives that each person brings to the organisation.

ABOUT THE POSITION

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

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

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

Main functions and responsibilities

- Prepare, review and maintain documentation related to:
- Manufacturing process validations.




- Cleaning validations of equipment and production facilities.
- Aseptic process simulations (media fills).
- Qualifications associated with the processes subject to validation.
- Prepare and manage the documentation necessary for validation activities, including risk assessments, validation plans and protocols, reports, procedures, validation matrices, Validation Master Plan (VMP) and any other necessary documentation.
- Coordinate and execute validation activities in collaboration with the departments involved, ensuring that studies and tests are carried out in accordance with approved protocols, internal procedures and applicable GMP requirements.
- Follow up validation studies, collect and evaluate results and complete protocols, records and reports, ensuring traceability, data integrity and compliance with documentation standards.
- Evaluate validation results, identify possible non-compliances or deviations from previously established 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 the management of change controls and in the definition and implementation of corrective and preventive actions (CAPAs).
- Work cross-functionally with Production, Quality Assurance, Quality Control, Microbiology, Engineering and other departments involved to ensure adequate planning and execution of validation activities.
- Participate, when necessary,



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.
- Carry out any other activity related to the position that may be assigned by the hierarchical or functional manager, in accordance with the corresponding 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, validations and/or GMP regulations, together with practical knowledge and experience in the application of Good Manufacturing Practices.
- Minimum of 3 years of experience in the pharmaceutical industry, including practical experience in manufacturing process validation, cleaning validation of equipment and production facilities and aseptic process simulations (media fills).
- Demonstrable 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 between different departments and effectively follow up deadlines and associated actions.
- Advanced level of IT tools.
- Fluent level of English, both written and spoken (C1).
- High attention to detail, analytical ability, teamwork and a proactive attitude oriented towards continuous improvement.

OTHER

We are looking for a meticulous, organised and results-oriented person, with the ability to manage critical documentation and collaborate effectively with different departments.

📌 Validation Technician – Pharmaceutical Processes (Zamudio)
🏢 Roxall Medicina España
📍 Zamudio