CSV Validation Specialist

3 days ago Be among the first 25 applicants About VRG Digital Solution Services (DSS): At Validation Resources Group (VRG), our Digital Solution Services (DSS) division is dedicated to empowering regulated industries through smart, validated, and scalable digital solutions. We partner with industry-leading platforms like Tulip Interfaces, to deliver high-impact applications across the quality and manufacturing lifecycle. Join a fast-growing team at the forefront of digital transformation in Life Sciences, Medical Devices. Role Purpose: We are hiring a meticulous and experienced CSV Validation Specialist to lead and execute Computer System Validation (CSV) activities. This role plays a critical part in ensuring that all digital systems meet regulatory requirements (FDA, GxP, ISO) within pharmaceutical and medical device environments. Key Responsibilities: Develop and execute validation deliverables (URs, FRS, RTM, IQ/OQ/PQ, etc.) for digital systems. Ensure alignment with 21 CFR Part 11, EU Annex 11, and other GxP regulations. Use validation platforms like Tulip and automated machines to manage electronic validation lifecycle. Collaborate with development and QA teams to ensure compliant integrations and deployments. Participate in audits, SOP development, and risk assessments. Support validation documentation reviews and approvals. Requirements & Experience: Bachelor’s degree in Life Sciences, Engineering, or related technical field / experience. 1–3 years minimum of experience in CSV and/or Quality Assurance in regulated industries. Strong understanding of GxP, FDA, ISO 13485, and validation principles. Experience with Kneat, Veeva, SIAM, SAP, OpenText or other validation/document management systems. Ability to draft, review, and execute validation protocols and traceability matrices. Excellent documentation and regulatory writing skills. Validation planning and execution Quality mindset and attention to detail Documentation accuracy GxP regulatory compliance Problem-solving and team collaboration Location: Hybrid or On-site (Puerto Rico) Employment Type: Full-Time / Contractor Ensure compliance in digital transformation. Join VRG Digital and bring your validation expertise to life sciences innovation. Seniority level

Mid-Senior level Employment type

Contract Job function

Quality Assurance

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