Role : CSV Engineer
Location : Remote (India)
Contract Type : Long-Term
Key Responsibilities :
- Develop and execute remediation activities for Computer System Validation (CSV) to assess, plan, and enhance CSV processes and execution in alignment with organizational and regulatory standards.
- Develop and execute validation plans for new and existing GxP computer systems and digital solutions.
- Lead and support various SDLC and Software Verification & Validation (V&V) activities, including requirements analysis, validation planning and reporting, testing, qualification, and other deliverables required to meet CSV objectives.
- Create and maintain validation documentation such as test protocols, reports, and risk / compliance assessments.
- Conduct assessments and periodic reviews of validated systems to ensure ongoing compliance with regulatory requirements and internal procedures.
- Provide subject matter expertise (SME) in CSV to system owners and users of validated systems.
- Collaborate with Quality Assurance teams to support the development and implementation of quality improvement initiatives.
Education :
Bachelor’s degree or equivalent in Computer Science, Engineering, Life Sciences, Data Science, or a related field (advanced degrees preferred).
Experience and Skills Required :
4–6 years of relevant experience in Computer System Validation (CSV).Experience in CSV within the medical device, MedTech, or pharmaceutical industry.Strong understanding of 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements such as ISO 13485, FDA CSA, and MDSAP.