Validation Engineer

• Develop and implement validation protocols (IQ/OQ/PQ) for sterile processes and equipment.
• Lead validation activities for new systems and modifications, ensuring readiness for scale-up.
• Apply medical-grade validation expertise to align with regulatory standards (FDA, ISO 13485, GMP).

• Create and maintain risk assessments, validation plans, and SOPs in accordance with industry standards.
• Collaborate with Quality, R&D, and Regulatory Affairs to ensure all validation practices support compliance goals.
• Support audits and inspections with high-quality documentation and technical clarity.

• Analyze validation outcomes to drive process efficiency and robustness.
• Identify deviations and lead corrective/preventive actions (CAPA).
• Innovate and improve validation approaches using data-driven methods.

• Be actively involved in qualification activities, system testing, and troubleshooting.
• Collaborate with engineering teams to integrate validation throughout the product lifecycle.
• Bridge R&D validation efforts with scalable manufacturing solutions.

• Work with multidisciplinary teams to ensure integrated, compliant validation strategies.
• Contribute expertise in sterility assurance, including CIP/SIP system validation.
• Ensure validation aligns with quality and product development timelines.

• B.Sc. in Engineering (Chemical, Mechanical, Biomedical, or related field).
• Minimum 3 years of validation experience in the medical device, pharmaceutical, or sterile manufacturing sector.
• Deep familiarity with FDA regulations, ISO 13485, GMP, and sterility validation standards.
• Proficient in generating validation documentation: PFDs, P&IDs, SOPs, and risk assessments.
• Hands-on knowledge of CIP/SIP validation, equipment qualification, and sterility testing.
• Skilled in using Excel or equivalent tools for analysis and reporting.
• Excellent problem-solving, communication, and team collaboration skills.
• Fluent in technical English, both written and spoken.

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