Validation Engineer

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.

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Company Intel

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