CSV Engineer

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 :