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

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