Company Description SecureGen provides secure computational platforms as a service to support the management of regulatory-compliant data, analysis, and tools for drug development. The company focuses on enabling innovation in life sciences by offering robust, secure, and scalable technology environments. SecureGen’s solutions help research and development teams work efficiently with sensitive data while meeting regulatory expectations. Team members collaborate with experts in technology, compliance, and drug development to advance secure digital infrastructure for the pharmaceutical and biotech sectors. Role Description The Computer System Validation Specialist is a full-time remote role responsible for ensuring that SecureGen’s platforms, tools, and workflows meet regulatory and compliance standards throughout their lifecycle. This role involves planning and executing validation activities, including creating and reviewing validation plans, test scripts, protocols, and reports for computer systems and related infrastructure. The specialist will collaborate with engineering, quality, and regulatory teams to assess system risks, define requirements, and verify that system functionality aligns with documented specifications.



Daily tasks include managing validation documentation, supporting audits and inspections, tracking deviations and corrective actions, and maintaining validation status for systems used in regulated drug development environments. The role also includes continuous improvement of validation processes and staying current with relevant guidelines and industry best practices. Qualifications
• Candidates should possess skills to effectively communicate validation procedures, standards, and best practices to cross-functional teams.
• Experience with computer system validation within regulated environments (e.g., GxP, FDA, EMA, or similar frameworks) and familiarity with relevant guidelines (such as GAMP) is highly beneficial.
• Solid documentation, analytical, and problem-solving skills, with attention to detail and the ability to work independently in a remote setting.
• Bachelor’s degree in a relevant field (such as Computer Science, Engineering, Life Sciences, or equivalent experience) is preferred.
• Comfort working with cloud-based platforms, data integrity principles, and collaboration tools used by distributed teams.

📌 Computer System Validation Specialist (India)
🏢 SecureGen
📍 India