ABOUT US
We are dedicated to the research, design, validation, manufacturing, and distribution of allergy vaccines within the immunotherapy sector.
Our Technical, R&D, and Clinical Trials departments are based in Zamudio, where our sole production facility is also currently located. Against this backdrop, we are looking at a solid growth outlook for the coming years.
Our value proposition for the people who are part of Roxall is based on:
- PEOPLE AT THE HEART OF WHAT WE DO: We are committed to our people and their professional development.
- SELF-MOTIVATED INDIVIDUALS: We foster individual responsibility aimed at achieving common goals.
- CURIOUS PEOPLE: We learn through innovation and value the experience and knowledge that each person brings to the organization.
ABOUT THE POSITION
We are looking for a Validation Technician to join our team in Zamudio on a permanent contract, reporting to the Area Manager.
Mission
Carry out the assigned tasks in accordance with the objectives set by the Area Manager (UV).
Duties and Responsibilities
- Develop, review, and keep up to date validation documentation, including risk analyses, validation plans, protocols, reports, the Master Validation Plan, procedures, matrices, and any other documentation required for cleaning, manufacturing, and aseptic process validations.
- Coordinate and carry out validation exercises, participating in the planning and execution of tests, manufacturing process validations, aseptic process validations, and/or cleaning validations, ensuring that all are performed in accordance with GMP regulations.
- Complete protocols, reports, and validation records, ensuring the traceability of information, data integrity, and compliance with internal procedures and GMP regulations.
- Identify and document deviations, assist in their investigation and root cause analysis, and participate in the management of change controls and the implementation of corrective and preventive actions (CAPA) if validation requires it.
- Collaborate effectively with various departments, maintaining clear and respectful communication; participate in internal and external audits as required; and assist in preparing responses to deficiencies and observations in coordination with the relevant departments, thereby contributing to regulatory compliance and the continuous improvement of processes.
- Any other duties assigned to you by your chain of command and/or functional supervisor in accordance with your current professional category.
Requirements
- Bachelor's Degree in Biosciences and/or Health Sciences or a related field
- Formal training in Pharmaceutical Process Validation or a similar field
- At least 3 years of experience in the section's area of expertise
- At least 2 years of experience in project management
- Fluent spoken and written English (C1)
- Computer Science at the User Level,
Personal Skills
- Attention to detail and a commitment to quality.
- Ability to organize and plan one's own work.
- Ability to learn and strictly follow procedures.
- Responsibility and autonomy in carrying out assigned tasks.
- Teamwork and collaboration.
- Ability to work in a methodical, structured, and organized manner.
WHAT DO WE OFFER?
- Join a growing biotechnology company specializing in immunotherapy.
- Direct participation in relevant laboratory and quality control activities.
- A highly regulated work environment focused on scientific and technical excellence.
- Professional development and lifelong learning.
- Become part of a collaborative team committed to innovation, quality, and continuous improvement.
- Permanent employment.
- A competitive compensation package commensurate with the candidate's experience and qualifications.
COMMENTS
- We are looking for a meticulous, organized, and quality-oriented individual with experience in laboratory settings and the ability to independently manage assigned tasks in accordance with established procedures.
- We particularly value the ability to learn, responsibility, attention to detail, and commitment, as well as a collaborative and proactive attitude within a demanding and highly regulated technical environment.
