Validation Engineer

Key Responsibilities: Execute commissioning, qualification, and validation (CQV) activities for GMP-regulated pharmaceutical and biopharmaceutical facilities. Prepare and review validation documentation, including Validation Plans, IQ/OQ/PQ protocols, test scripts, and final reports. Support equipment, utilities, facilities, and computerized systems validation in compliance with GMP, GAMP 5, and 21 CFR Part 11 requirements. Coordinate with project engineers, QA, clients, and vendors to ensure timely completion of validation deliverables. Perform risk assessments, impact assessments, and deviation investigations, and implement appropriate CAPA. Ensure all validation activities comply with applicable regulatory requirements and company quality standards. Support FAT, SAT, commissioning, and qualification activities for new equipment and systems. Maintain accurate documentation and ensure data integrity throughout the validation lifecycle. Requirements: Bachelor's degree in engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline. 3-5 years of validation/CQV experience in the pharmaceutical or biopharmaceutical industry. Good knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and data integrity requirements. Experience with equipment, utilities, cleanrooms, HVAC, water systems, or computerized system validation is preferred. Strong documentation, analytical, and problem-solving skills. Good communication skills and the ability to work effectively in a multidisciplinary project environment.