ValGenesis is a company specializing in digital validation lifecycle management solutions for the life sciences industry. Their platforms, such as VLMS and ValGenesis iRisk, provide comprehensive digital solutions for validation, risk management, and process optimization. These solutions are designed to enhance efficiency, ensure compliance, enforce standardization, and support digital transformation in manufacturing and corporate operations. ValGenesis facilitates a 100% paperless validation process, offering capabilities like electronic logbooks, process insight management, and quality risk management using digital twins and machine learning.
Software system for Validation Lifecycle Management Process • Paperless Validation • Validation Lifecycle Management System • Cleaning Validation • Electronic Validation
January 28
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ValGenesis is a company specializing in digital validation lifecycle management solutions for the life sciences industry. Their platforms, such as VLMS and ValGenesis iRisk, provide comprehensive digital solutions for validation, risk management, and process optimization. These solutions are designed to enhance efficiency, ensure compliance, enforce standardization, and support digital transformation in manufacturing and corporate operations. ValGenesis facilitates a 100% paperless validation process, offering capabilities like electronic logbooks, process insight management, and quality risk management using digital twins and machine learning.
Software system for Validation Lifecycle Management Process • Paperless Validation • Validation Lifecycle Management System • Cleaning Validation • Electronic Validation
• Location: USA (Remote/Hybrid), India (Chennai, Hyderabad, Bengaluru) • Department: Engineering • Type: Contract, Part-Time, Full-Time • About ValGenesis: ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. • Job Description: We are seeking a highly skilled AI/ML Solution Architect to lead the design and implementation of advanced AI and machine learning backed features in our flagship products. This role focuses on knowledge management, semantic search, image processing, and predictive analytics to support Continued Process Verification (CPV) and Annual Product Quality Review (APQR) programs. The ideal candidate will have deep technical expertise, a strong grasp of regulated industry needs, and experience in deploying scalable AI/ML systems.
• AI/ML Development & Implementation • Build scalable AI/ML models for document classification, intelligent search, and predictive analytics. • Implement image processing solutions for visual inspections and anomaly detection in validation processes. • Define the AI architecture and select appropriate technologies from a pool of open-source and commercial offerings. Select cloud, on-premises or hybrid deployment models • ensure new tools are well-integrated with existing data management and analytics tools. • Deploy AI/ML solutions in cloud-based environments with high availability and security. • Stay current with the latest advancements in machine learning and artificial intelligence, and actively shape the application of AI/ML within the life science industry. • Provide mentorship to team of AI/ML engineers, fostering a collaborative environment conducive to ongoing research and development. • Data Management & Knowledge Systems • Architect AI-driven knowledge management systems for life sciences datasets. • Design efficient search tools using natural language processing (NLP) to enable rapid data retrieval. • CPV & APQR Automation • Develop statistical models and machine learning pipelines for batch monitoring, failure prediction, and process optimization. • Collaboration & Compliance • Work closely with cross-functional teams, including product managers, data scientists, validation specialists, to identify and pilot the use cases. • Discuss the feasibility of use cases along with architectural design with product functional teams and translate the product vision into realistic technical implementation. • Bring attention to misaligned initiatives and impractical use cases. • Ensure compliance with FDA, EMA and other global regulatory requirements. • Innovation & Strategy • Research emerging technologies and recommend the adoption of advanced AI/ML frameworks. • Guide the engineering team in implementing best practices for AI/ML development.
ValGenesis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, age, national origin, religion, marital status, sexual orientation, ancestry, color, gender identity / expression, family / medical care leave, genetic information, medical condition, physical / mental disability, political affiliation, status as a protected veteran, status as a person with a disability, or other characteristics protected by laws or regulations.
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