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Hi , Greetings from Uniqsoft INC!!! We have "Validation Lead" Open positions at "Remote" Long term Contract position. Job Title: Validation Lead Location: Remote Position type: Long term Contract Job Description: 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 MatrixSupport actions related to Change Management, Deviations and CAPAs Primary (Must have 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, GMPWell versed in HP ALM tool (for writing, approving and executing test scriptsSolid Manual QA work experienceExcellent 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 Secondary Skills (Good To have Working knowledge of Agile methodologyOnsite-offshore coordination experience will be a plus Soft skills/other skills (If any) Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders. Educational Qualification* Bachelors degree in Computers or equivalent Skills Matrix: Total work experience in IT Industry: Total work experience in USA: Validation Lead: Years Validation principles: Years HP ALM tool: Years Executing test scripts: Years Agile methodology: Years