Qualifications and Validation Technician

• Indefinite and stable contract in a project with a high global impact and in the midst of an international expansion process.
• Professional and personal development in a young and dynamic environment.
• Competitive salary based on experience and an attractive benefits package.
• Flexible schedule for personal/family work-life balance.
• Flexible compensation (restaurant vouchers, transport, and childcare).
• Access to the iWellness program: gym and physiotherapist in our facilities.
• Corporate events and gifts.
• Subsidized company canteen.

• Scientific-technical profile with a degree in chemistry, health sciences, engineering, or related fields. Knowledge of applicable regulations:
• ISO 13485: Medical devices.
• FDA 21 CFR part 820
• GMP Annex 15.
• ISO 14971: Risk management for medical devices.
• ISO 14644: Cleanrooms. - Knowledge in the following is valued:
• Full professional proficiency in English.
• Advanced Microsoft Office user.

Experience:

Minimum 4 years in process and cleaning validation within the medical device, pharmaceutical, or related industry.

Experience in the development and execution of IQ, OQ, PQ validation protocols.

Skills and attitudes:

• Person with analytical capacity, proactive, and focused on problem-solving.
• Teamwork and interdepartmental communication skills.
• Meticulous, efficient, rigorous, dynamic, and organized person.
• Adaptability to regulatory and technological changes.

• GAMP5 for the validation of computerized systems.
• Statistics applied to processes.
• ISO 14644: Cleanrooms.

Academic background:__SJ_

LVD Biotech - iVascular Group is an international medical technology group specializing in the development, manufacturing, marketing, and distribution of innovative medical devices for the treatment of vascular system pathologies worldwide. Our vertical integration model allows us to integrate the entire product lifecycle.

The group is formed by two highly specialized and complementary companies:

• LVD Biotech, our innovation center, leads and drives the research and development of new technologies, managing the complete product development cycle from the initial idea conception to the preparation of the registration dossier, including the generation and protection of knowledge through intellectual property.
• iVascular converts that innovation into medical solutions that reach healthcare professionals and patients through the manufacturing, logistics, marketing, and international commercialization of a portfolio of medical devices for the Coronary, Peripheral, and Neurovascular areas.

With a team of more than 600 professionals and a commercial presence in more than 86 countries, both companies work in an integrated manner in a continuous collaboration environment that combines science, innovation, industrial excellence, and the highest quality standards. Together, we drive the development of medical solutions based on cutting-edge technologies with a common goal: to improve the quality of life of patients worldwide.

Ensure that medical device manufacturing processes comply with quality, safety, and regulatory standards through systematic validation, guaranteeing their robustness and repeatability.

• Design, plan, and execute key process validations.
• Develop and review validation protocols and reports (IQ, OQ, PQ) in accordance with current regulations.
• Execute repeatability and reproducibility tests to guarantee process stability. Apply risk analysis methodologies to identify critical points and verify the suitability of process controls and limits.
• Analyze statistical data and define acceptance limits for critical variables.
• Execute cleaning validations to minimize cross-contamination.
• Perform residue studies on manufacturing equipment and define effective cleaning strategies. Coordinate necessary validation activities with the involved departments to optimize validated processes, guaranteeing their compliance with regulations and validation status.
• Ensure that validated processes maintain their performance over time through periodic revalidation activities.
• Manage deviations and non-conformities detected during validation, proposing and executing corrective and preventive actions (CAPA).
• Keep validation documentation up to date and participate in internal and external audits. Evaluate and propose improvements in production processes to increase efficiency without compromising quality.
• Development and execution of the Validation Master Plan. Report any deviation from the plan.
• Review of current procedures and protocols to ensure alignment with GMP Annex 15 regarding qualification and validation.
• Evaluate new technologies and participate in the qualification of new machines and production systems.