Validation and Qualification Engineer

• Participation in a strategic pharmaceutical project with great potential.
• International and highly regulated environment.
• Real opportunities for professional development and internal growth.
• Exposure to new implementation projects and industrial start-ups.
• Continuous training and technical development in GMP validations and qualifications.

Important pharmaceutical company in growth is looking to incorporate a Validation and Qualification Engineer for equipment within a GMP environment. Excellent opportunity to join an industrial project of high technical complexity within the pharmaceutical sector.

• New sterile pharmaceutical plant with strong technical growth and development.
• Validations and qualifications of equipment, facilities, and critical utilities.

Reporting to the Validation and Qualification Manager, the selected person will be responsible for:

• Preparing, reviewing, and executing qualification and validation protocols and reports under GMP.
• Participating in IQ, OQ, and PQ activities for equipment, facilities, and critical utilities.
• Providing support for FAT and SAT activities and the start-up of new equipment.
• Collaborating in risk analyses and the definition of qualification strategies.
• Managing deviations, investigations, CAPAs, and actions derived from validation activities.
• Ensuring compliance with regulatory requirements in accordance with EU GMP, Annex 15, and applicable regulations.
• Drafting and maintaining procedures, work instructions, and associated technical documentation.
• Collaborating closely with the Production, Engineering, Quality, Laboratory, and Maintenance departments.
• Providing support during internal audits, client audits, and regulatory inspections.
• Supervising external suppliers involved in qualification and validation activities.
• Contributing to the continuous improvement of validation processes within the organization.

• University degree in Engineering, Pharmacy, Biotechnology, Chemistry, or a related field.
• Minimum of 3 years of experience in validation and qualification functions within the pharmaceutical sector.
• Experience working under GMP regulations.
• Experience in sterile production environments will be valued.
• Knowledge of Annex 15, process validations, equipment, facilities, and computerized systems.
• High level of English, both oral and written.
• Ability to work under pressure and manage multiple priorities simultaneously.
• Dynamic, organized, and results-oriented profile.
• Communication and teamwork skills.
• Ability to work in multidisciplinary and international environments.