Company Description Ranucal Instrumentation (OPC) Private Limited is a trusted calibration and validation partner serving pharmaceutical, food, chemical, and healthcare industries across India. The company specializes in NABL traceable calibration, computer system validation (CSV) aligned with GAMP 5 and FDA 21 CFR Part 11, equipment qualification, and thermal validation and temperature mapping. Ranucal also offers PRAKAAR TECH CMS, a digital calibration management platform that supports GMP compliance and streamlined quality processes.

Accredited to NABL and ISO/IEC 17025:2017 standards, the organization is trusted by more than 100 industry leaders, providing a stable and quality-focused workplace for professionals in validation and instrumentation.

Role Description The CSV Engineer will be responsible for planning, executing, and documenting Computer System Validation activities in alignment with GAMP 5, FDA 21 CFR Part 11, and relevant regulatory guidelines. Day-to-day tasks include developing and reviewing validation plans, user requirements, functional specifications, test scripts, and reports for laboratory, industrial, and digital systems, including calibration management platforms. The role involves collaborating with quality assurance, engineering, and client teams to ensure data integrity, system compliance, and audit readiness, as well as supporting equipment qualification and GMP compliance initiatives when required.





The CSV Engineer will participate in on-site activities at client locations in and around Aurangabad and perform documentation, analysis, and coordination tasks remotely as appropriate. This is a full-time hybrid role based in Aurangabad, with a combination of on-site and work-from-home responsibilities.

Qualifications

- Strong knowledge of Computer System Validation principles, including GAMP 5, FDA 21 CFR Part 11, and data integrity guidelines.
- Experience creating and reviewing validation documentation such as URS, FRS, risk assessments, test scripts (IQ/OQ/PQ), and validation summary reports.
- Understanding of GMP, ISO/IEC 17025:2017, and quality management systems within pharmaceutical, food, chemical, or healthcare environments.
- Familiarity with calibration processes, equipment qualification, thermal validation, and digital calibration or CMS platforms is an advantage.
- Proficiency in technical writing, documentation control, and use of common office and validation tools (e.g., spreadsheets, databases, test management systems).
- Bachelor’s degree in Engineering, Pharmacy, Science, or a related technical discipline; relevant certifications in CSV or GxP compliance are beneficial.
- Strong analytical and problem-solving skills, with attention to detail and ability to interpret regulatory and technical requirements.
- Effective communication and collaboration skills, with the ability to work in cross-functional teams and interact with clients professionally.

📌 CSV Engineer (Aurangabad)
🏢 Ranucal Instrumentation (OPC) Private
📍 Aurangabad