Validation Engineer

Role Description•   Develop and execute validation protocols (Installation Qualification, Operational Qualification, Performance Qualification – IQ/OQ/PQ).•   Conduct risk assessments and define validation acceptance criteria.•   Perform validation for equipment, facilities, utilities (e.g., HVAC, purified water systems), and manufacturing processes and computer system validation activities.•   Prepare and maintain validation documentation, including plans, protocols, reports, and traceability matrices, in accordance with cGMP standards.•   Review and approve validation documentation from vendors and contractors.•   Ensure validation activities are aligned with current regulatory guidelines (FDA, EMA, ICH, WHO, ISO…).•   Participate in change control, deviation, and CAPA management related to validation.QualificationsEducationBachelor's degree in Business Administration, International Trade, Supply Chain Management, or a related fieldExperience •   Bachelor’s or master’s degree in engineering  (Chemical, or Biomedical), Life Sciences, or a related field.•   Minimum 5 years of experience in a GMP-regulated environment (pharmaceuticals, biotechnology, medical devices, or similar).•   Strong understanding of validation principles, quality systems, and regulatory requirements (21 CFR Parts 210/211, Part 11, EU GMP Annex 15, ICH Q7–Q10, GAMP 5).•   Experience with equipment, utility, process and computerized systems validation (CSV).•   Knowledge of statistical tools and risk-based validation approaches (e.g., FMEA).•   Excellent documentation, communication, and project management skills.•  Strong attention to detail and ability to manage multiple projects simultaneously.•  Ability to communicate and report in EnglishKey Competencies:•   Analytical and problem-solving mindset.•   Strong written and verbal communication skills.•   Collaborative team player with cross-functional experience.•   Proactive and adaptable in fast-paced environments.•   High level of integrity and commitment to quality.