Sr. CSV Engineer, China, Hongyi Team

Sr. CSV Engineer, China, Hongyi Team Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies . With over 25 years of experience and a world-renowned focus in renal research , Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role Emerald is currently looking for a Computer System Validation (CSV) Specialist with strong experience in computer systems and IT infrastructure to join our team in Shanghai， China. The candidate will be a member of the IT team responsible for ongoing support for information system compliance activities， including but not limited to， system validation or qualification， creating and implementing best practices within the framework of GxP， 21 CFR Part 11， and GAMP 5 regulations， risk assessment， vendor qualification， sponsor audit， change control， drafting test scripts and protocols， reviewing GxP documentation revisions， etc. 弘翼临床目前正寻找一位在计算机系统和IT基础设施方面拥有丰富经验的计算机系统验证（CSV）专员，加入我们在上海的团队。该候选人将成为IT团队的一员，负责持续支持信息系统合规活动，包括但不限于：系统验证或确认，在GxP、21 CFR Part 11和GAMP 5法规框架内制定并实施最佳实践，风险评估，供应商确认，申办方审计，变更控制，起草测试脚本和方案，以及审查GxP文档修订等。 Responsibilities l Responsible for planning, scheduling, executing and leading validation project assignments in coordination with business functions and in accordance with Good Clinical Practices (GCPs)，FDA 21CFR Part 11，and Good Automated Manufacturing Practice (GAMP5). l Validation assignments include validation, qualification, and implementation of new and existing, processes, equipment, software, and clinical information systems. l Leads cross-functional project teams in the development and implementation of the validation plan and protocols. l Prioritizes, manages, and executes multiple projects utilizing Project Management methodology. This may include assignment/oversight/review of validation projects to other personnel/teams. l Review and approve all validation documentation (plans, protocols, summary reports, etc), including vendor documentation. l Acts as the primary validation contact source for sponsors, vendors, the agencies (NMPA, FDA, etc.). Provides support for regulatory submissions and regulatory agency inspections as required. l Maintains a thorough knowledge of the organization, policies and Standard Operating Procedures(SOPs) , adheres to all organizational standards defined in SOPs and the Employee Handbook, and coordinates with IT team activities. l Support development of best demonstrated validation practices within the IT department, based on current industry practices and guidelines. l Champions continuous improvement of Company’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout Emerald. l Review/harmonize SOPs, and author assigned SOPs to ensure compliance with Company policies and industry regulations. l Review of all system SOPs to ensure compliance requirements are met and qualified/validated state is maintained. l Develop/modify templates for system life cycle suite of documents including evaluation checklist and SOW (pre purchase). l Develop additional validation/qualification/system SOPs as required. l Provides business support and training to users for validated systems as assigned. l Schedule regular meetings with QA to identify and ensure compliance of system validation and qualification projects. l Maintain VMP, Vendor questionnaires as applicable. l Other projects related to compliance of systems and other duties as assigned. About You l Bachelor’s degree (or above) applicable to a pharmaceutical, biotech, or CRO environment. l A minimum of 5 years in a regulated, GxP environment validating and qualifying equipment, computer and application systems, and processes. l Extensive, in-depth knowledge and understanding of Good Clinical Practices (GCP) and quality requirements in an FDA-regulated environment along with knowledge of 21 CFR Part 11. l Advanced knowledge of computer system validation (CSV) and familiarity with common IT infrastructure and system. l Exceptional written and verbal English communication skills with superior organizational skills. l Excellent problem-solving skills and the ability to analyze critical issues and develop assessments for risk and impact quickly and effectively. l Ability to utilize Project Management methodologies to manage validation projects. l Ability to work in a high pressure, fast-paced, ever-changing environment. l Ability to work with various scientists and management across various departmental groups to achieve company’s goals and objectives. l Ability to work independently and manage time with respect to project priorities. l Have thorough understanding of clinical trials industry and processes. l Ability to work and administrate various clinical information systems required for validation development and execution, with the appropriate training provided by the company or the vendor if required. l Advanced knowledge and experience of Microsoft Office applications and IT technologies (server, storage, network technologies). l Firm understanding of all associated technology platforms as needed for validation projects. l PMI PMP certified highly preferred. Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work : You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise : Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience. • Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates. Locations China - Shanghai Remote status Hybrid