Validation Engineer III
6 days ago
About the Role:
As a Validation Engineer III at TekOne IT Services Pvt. Ltd., you will play a crucial role in ensuring the quality and reliability of our In Vitro Diagnostic Lab equipment. Your expertise in validation of complex systems, such as Real-Time PCR Systems, Freezers, Refrigerators, Environmental Chambers, and Incubators, will be instrumental in maintaining our high standards of compliance.
Key Responsibilities:
• Validate In Vitro Diagnostic Lab equipment to ensure compliance with regulatory requirements
• Conduct thorough testing and verification of equipment to ensure accuracy and reliability
• Collaborate with cross-functional teams to develop and implement validation protocols
• Support ISO 13485 inspections and FDA inspections by providing documentation and evidence of validation processes
• Develop and maintain compliance management systems to ensure adherence to regulatory requirements
• Work with Agile, Maximo, and ViewLinc to ensure seamless integration with our development environment
Requirements:
• Experience in validation of In Vitro Diagnostic Lab equipment and Computerized System Validation
• Strong understanding of GAMP5 and FDA's Computer Software Assurance initiatives
• Familiarity with Agile development methodologies
• Excellent communication and collaboration skills
• Ability to work in a fast-paced, dynamic environment
What We Offer:
• Competitive salary and benefits package
• Opportunities for professional growth and development
• Collaborative and dynamic work environment
• Recognition and rewards for outstanding performance
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