Computerized System Validation (CSV) Specialist

Computerized System Validation (CSV) Specialist — Contract (Remote) Job Type: Contract — 12-month engagement, with strong possibility of extension Location: Remote Start Date: Immediate availability strongly preferred About DoubleBridge Technologies DoubleBridge Technologies is a global software and consulting company serving pharmaceutical, biotechnology, and life sciences organizations worldwide. Our expertise spans Computerized System Validation (CSV), Quality Engineering (QE), Regulatory Operations, eCTD Publishing, AI-enabled validation, and enterprise software solutions. We support some of the world's leading pharmaceutical companies by providing experienced professionals who deliver high-quality software validation, testing, and regulated system implementation services. Position Summary We are seeking an experienced Computerized System Validation (CSV) Specialist to support validation activities for a global pharmaceutical client operating within regulated environments. This is a hands-on validation delivery role responsible for executing and coordinating computerized system validation activities throughout the Software Development Lifecycle (SDLC) and Validation Lifecycle. This is a 12-month contract position, with the opportunity to extend based on performance and client needs. Candidates who can start immediately or on short notice will be prioritized. The successful candidate will work as part of the client's validation organization, collaborating closely with business users, Quality Assurance, Development, Testing, Infrastructure, and Project Management teams to ensure systems are validated, compliant, and ready for production deployment. Key Responsibilities Execute computerized system validation (CSV) activities throughout the system validation lifecycle Prepare, review, and maintain validation documentation, including Validation Plans, Requirements Traceability Matrix (RTM), Functional and Design Review documentation, Test Protocols (IQ/OQ/PQ/UAT), Validation Reports, and Validation Summary Reports Coordinate validation activities across Business, Development, Testing, Infrastructure, and Quality teams Support software validation planning, verification, deployment readiness, operational support, and business continuity activities Participate in requirements reviews to ensure completeness, traceability, and testability Support risk assessments and validation planning using risk-based validation principles Coordinate User Acceptance Testing (UAT), defect management, deviation tracking, and issue resolution Ensure validation deliverables comply with client quality procedures and regulatory expectations Support change control, system enhancements, periodic reviews, and validation maintenance activities Maintain high-quality documentation suitable for regulatory inspection and audit readiness Required Qualifications Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline Minimum 5 years of experience in Computerized System Validation (CSV), Software Validation, Software Quality Assurance, or Validation Delivery within pharmaceutical, biotechnology, medical device, or other regulated industries At least mid-level knowledge of Computerized System Validation, Quality Assurance, and regulated environments Practical experience with Software Development Lifecycle (SDLC), System Lifecycle, and Validation Lifecycle methodologies Working knowledge of Infrastructure Lifecycle Solid understanding of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 Strong grasp of Data Integrity principles and Risk Management methodologies Experience preparing, reviewing, or coordinating validation documentation for GxP-regulated computerized systems Strong understanding of software testing methodologies and User Acceptance Testing (UAT) Ability to manage multiple priorities in a fast-paced project environment Preferred Qualifications Experience in one or more of the following is an advantage: Laboratory, Clinical, Regulatory, or Manufacturing systems Document Management Systems (DMS) or Trial Master File (TMF) Cloud-based GxP applications Validation automation and Agile software delivery environments Tools such as Jira, HP ALM / Quality Center, Azure DevOps, qTest, SharePoint; basic SQL knowledge a plus English Language Requirement (Mandatory) Excellent English communication skills are required. This position directly supports global pharmaceutical clients. Candidates must be able to communicate fluently and professionally in English, both verbally and in writing, including participating in daily meetings with international stakeholders, leading discussions with business and technical teams, and writing professional validation documentation. Business-level spoken and written English is mandatory. What We Offer 12-month contract with strong potential for extension Fully remote work with a global pharmaceutical client Opportunity to work on regulated, high-impact validation projects How to Apply Please send your resume/CV to hr@doublebridge.com. Candidates who are available to start immediately or on short notice are strongly encouraged to apply. Pay: $81,619.46 - $98,294.41 per year Work Location: Remote