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.
Qualifications

Education

Bachelor's degree in Business Administration, International Trade, Supply Chain Management, or a related field

Experience

•   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 English

Key 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.