Validation Engineer

Key Responsibilities

• Execute Commissioning, Qualification, and Validation (CQV) activities for GMP-regulated pharmaceutical and biopharmaceutical facilities.

• Prepare, review, and execute validation documentation, including Validation Plans, IQ/OQ/PQ protocols, test scripts, and final reports.

• Support the validation of equipment, utilities, facilities, cleanrooms, HVAC, water systems, and computerized systems in compliance with GMP, GAMP 5, and FDA 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 support the implementation of 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 relevant 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 in validation of equipment, utilities, cleanrooms, HVAC, water systems, or computerized systems is preferred.

Strong documentation, analytical, and problem-solving skills.

Good communication and interpersonal skills, with the ability to work effectively in a multidisciplinary project environment.

Experience in pharmaceutical, biopharmaceutical, EPC, or cleanroom projects will be an advantage.