This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Engineer, Computer Software Assurance based in India.

Join a technology-driven team dedicated to ensuring the safety, quality, and reliability of computerized systems used in regulated healthcare environments. In this role, you will lead computer system validation initiatives that support compliance with global regulatory standards across medical device and life sciences operations. You will oversee validation strategies for enterprise platforms, manufacturing systems, quality management software, and other GxP-regulated applications. Working closely with cross-functional stakeholders, you will help ensure systems are secure, reliable, and fit for their intended use. Your expertise in risk-based validation, data integrity, and regulatory compliance will contribute to operational excellence and product quality. This opportunity offers the chance to strengthen validation practices, support innovative technologies,



and drive continuous improvement in a highly regulated workplace. If you have strong technical expertise and a passion for quality assurance, this role offers meaningful opportunities to make a difference in healthcare technology.

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Accountabilities

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Lead the development and execution of comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) strategies, plans, and protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

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Oversee validation activities for GxP-regulated computerized systems, including enterprise resource planning (ERP) platforms, quality management systems (QMS), manufacturing execution systems (MES), manufacturing equipment software, data integrity systems, and custom applications.

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Ensure computerized systems comply with applicable regulatory requirements, including FDA 21 CFR Part 820, 21 CFR Part 11,

📌 Engineer, Computer Software Assurance (India)
🏢 Jobgether
📍 India