Validation (CSV) Engineer | Life Sciences

As a CSV Validation Specialist, you will play a pivotal role in developing and executing validation strategies for CSV projects, ensuring compliance with industry standards and company policies. Together with your team, you will create and maintain comprehensive validation documentation, including validation plans, protocols, and reports in accordance with SOP-1705 and other relevant SOPs in pharmaceutical industry.

• Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to ensure all validation efforts meet project timelines and specifications.
• Ensure adherence to regulatory requirements (e.g., FDA, ISO) and internal compliance standards throughout the validation lifecycle.
• Provide guidance and training to team members on CSV best practices and procedural compliance.

• Bachelor's or master's degree in a related field (e.g., Computer Science, Information Technology, Engineering).
• Minimum of 3-5 years of experience in CSV validation, preferably in a regulated environment.
• Comprehensive knowledge of the Software Development Life Cycle (SDLC) and its application within validation processes.
• Strong analytical and problem-solving skills to identify issues and implement corrective actions.
• Strong background in IT validation, specifically within the pharmaceutical or healthcare industry.

Nice to Have

• Familiarity with industry standards and regulations relevant to CSV (e.g., GxP, 21 CFR Part 11).
• Experience with validation tools and methodologies.
• Ability to create detailed, compliant documentation (SOPs, validation protocols, reports).

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