Computer Validation Engineer(CSV)

11 hours ago

Bengaluru, Karnataka, India ACL Digital Full time

We are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices. The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation including validation plans, security plans, VSRs, SOPs, change management, and CAPA.

Key Responsibilities:


• Develop comprehensive and regulatory-compliant documentation for CSV processes.


• Translate complex technical concepts into clear, accessible language for diverse stakeholders.


• Apply industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.


• Collaborate with cross-functional teams to gather inputs and feedback.


• Draft precise and actionable user stories reflecting functional and compliance requirements.


• Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.


• Document change control processes and prepare CAPA reports.

Qualifications:


• Bachelor's degree in computer science, Life Sciences, or related field (Master's preferred).


• Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain.


• Strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks.


• Excellent writing, editing, and stakeholder engagement skills.


• Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.

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