Validation Technician

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.

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.

• 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.

• 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.