Computer System Validation (CSV) Engineer – eDHR Implementation (Tulip Platform)

Computer System Validation (CSV) Engineer – eDHR Implementation (Tulip Platform)Location: Bangkok, Thailand (Hybrid)Company: Virtual Manufacturing ThailandIndustry: Life Sciences / Digital Manufacturing / Pharma / MedTechAbout Us:At Virtual Manufacturing, we believe in LEAN principles and bringing value to production and customers. We utilise a range of digital tools, including Tulip (https://tulip.co/), a frontline operations platform, to help our customers achieve operational excellence. Join our innovative team and contribute to impactful projects. We offer a collaborative work environment and opportunities for professional growth and development, along with the flexibility to work from anywhere and manage your own time.Role Overview:We're seeking a Computer System Validation (CSV) Engineer to join our growing team supporting digital transformation in regulated manufacturing environments. You will play a critical role in developing and validating an electronic Device History Record (eDHR) solution using the Tulip Frontline Operations Platform (tulip.co).This position is ideal for an experienced validation professional who understands both GxP compliance and modern digital manufacturing systems, and is excited to bridge quality and technology in life sciences. You will collaborate closely with our implementation engineers, quality teams, and client stakeholders to ensure solutions are compliant, robust, and audit-ready.Key Responsibilities:Lead the Computer System Validation (CSV) activities for the eDHR solution built on the Tulip platform, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.Develop, review, and execute validation documentation, including:Validation Master Plan (VMP)User Requirements Specification (URS)Risk Assessments (RA)Functional and Design SpecificationsIQ/OQ/PQ protocols and reportsCollaborate with cross-functional teams to define system requirements, data integrity controls, and change control processes.Ensure proper traceability from requirements through testing and deployment.Support vendor qualification and audit readiness activities related to Tulip implementation.Provide training and support to project and client teams on CSV best practices.Participate in continuous improvement of validation templates, standards, and frameworks.Qualifications Required:Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or a related field.Minimum 3–5 years of experience in Computer System Validation within the life sciences industry(pharmaceutical, biotechnology, or medical devices).Strong understanding of GxP, Part 11 compliance, Annex 11, GAMP 5, and data integrity principles.Experience validating Manufacturing Execution Systems (MES), LIMS, or eDHR systems.Familiarity with low-code/no-code platforms (e.g., Tulip, Power Apps, or similar).Excellent documentation and technical writing skills.Strong attention to detail and ability to manage multiple validation deliverables simultaneously.Collaborative mindset with the ability to work effectively with Quality, IT, and Engineering teams.Preferred Qualifications:Experience with Tulip Frontline Operations Platform or other digital manufacturing solutions.Prior involvement in eDHR system implementation in FDA-regulated environments.Knowledge of agile or hybrid project delivery methodologies.Why Join UsWork on cutting-edge digital transformation projects in regulated manufacturing environments.Collaborate with global clients and industry leaders driving Industry 4.0 innovation.Be part of a team that values excellence, curiosity, and growth.Competitive compensation and opportunities for professional development and Tulip certification.This is an excellent opportunity for someone who thrives in a multicultural setting and enjoys working on international projects. Join us at Virtual Manufacturing and make a difference!