Validation Engineer

We are seeking a skilled Validation Engineer with expertise in single-use technology (SUT) to support validation activities related to bioreactors, mixing systems, and other disposable process equipment used in biopharmaceutical manufacturing.

This critical role is responsible for ensuring the reliability, efficiency, and regulatory compliance of bioprocessing equipment by developing and executing validation protocols (IQ/OQ/PQ) that meet GMP, FDA, EMA, and industry standards.

• Develop, execute, and document validation protocols (IQ, OQ, PQ) for single-use bioreactors, mixing systems, and other process equipment.
• Evaluate and ensure compliance with GMP, FDA, EMA, ISO, and industry standards related to single-use technology.
• Perform risk assessments and gap analyses for single-use components to ensure process integrity.
• Collaborate with cross-functional teams to support validation efforts and drive innovation in biopharmaceutical manufacturing.
• Investigate and resolve validation deviations, anomalies, and non-conformances to minimize downtime and optimize equipment performance.
• Author and review Standard Operating Procedures (SOPs), User Requirement Specifications (URS), and Validation Master Plans (VMPs) to ensure consistency and accuracy.
• Lead and participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning of single-use systems to ensure smooth deployment and operation.
• Conduct performance qualification studies, including sterility, extractables & leachables testing, and integrity testing to guarantee the quality and reliability of single-use systems.
• Stay updated with industry trends, technological advancements, and regulatory changes affecting single-use technologies to drive business growth and competitiveness.
• Provide training and technical support on validation processes to internal stakeholders to enhance their skills and knowledge.

• Bachelor's or Master's degree in Engineering, Biotechnology, Biochemistry, or a related field.
• A minimum of 5 years of validation experience in the biopharmaceutical or medical device industry.
• Strong knowledge of GMP, FDA 21 CFR Part 11, ISO 13485, USP, and ICH guidelines.
• Experience with risk-based validation approaches and industry best practices.
• Familiarity with data integrity principles, electronic validation systems, and automation is an advantage.