SSDE/Module Lead – Validation Engineer

Location: Bangalore or Hyderabad

• 4 to 8 Years
• Develop and execute validation plans, protocols, and reports for new product development, process improvements, and equipment qualification.
• Collaborate with cross-functional teams, including application, quality assurance, and regulatory affairs, to define validation requirements and ensure compliance with applicable regulations and standards.
• Perform risk assessments to identify potential validation issues and develop mitigation strategies.
• Design and execute validation tests, including GxP application flow, to verify system functionality, performance, and reliability.
• Analyze validation test data and generate comprehensive reports, highlighting any deviations or non-conformances and proposing corrective actions.
• Conduct root cause analysis investigations for validation failures or non-conformances and implement corrective and preventive actions (CAPAs) to address identified issues.
• Maintain accurate documentation of validation activities, including protocols, reports, standard operating procedures (SOPs), and change control records.
• Collaborate with suppliers and vendors to ensure their products meet validation requirements and assist in supplier audits when necessary.
• Stay current with industry trends, regulatory guidelines, and best practices related to validation engineering.
• Contribute to continuous improvement efforts by identifying opportunities to streamline validation processes and enhance overall efficiency.
• Document Validation Summary Report and Requirements Traceability Matrix
• Support actions related to Change Management, Deviations and CAPAs
• Ensure compliance with Gilead standards, policies, and procedures

Primary Skills

• Proven experience in validation engineering, preferably in a regulated industry such as pharmaceuticals, medical devices, or biotechnology.
• Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA, ISO, GMP).
• Well versed in HP ALM tool (for writing, approving, and executing test scripts.)
• Solid Manual QA work experience
• Excellent analytical and problem-solving skills, with the ability to analyze complex data sets and identify trends and patterns.
• Detail-oriented mindset with strong organizational and documentation skills.
• Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.

Key Skills: GXP, GMP. FDA, HP ALM, Manual Testing