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Ranadheer M
Mid-level Process Engineer specializing in biopharmaceutical GMP manufacturing
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About
CQV/validation professional with hands-on experience at Catalent supporting a biologics manufacturing expansion, including upstream bioreactors, CIP, WFI, and DeltaV-integrated systems. Stands out for combining field execution, troubleshooting, and cross-functional coordination with strong GDP/ALCOA+ documentation and GMP traceability discipline through turnover and OQ readiness.
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Key Strengths
- hands-on GMP CQV support for biologics manufacturing expansion
- strong IQ/OQ execution for bioreactors and utility systems
- deep GDP and ALCOA+ documentation discipline
- requirements traceability from design/URS through test execution
- effective field troubleshooting with vendors and contractors
- cross-functional coordination across engineering, QA, validation, automation, and construction
- capital project support from design review through installation and turnover
- proactive identification of constructability and installation issues
- punch list and turnover deliverable management
- ability to resolve system readiness conflicts while protecting GMP compliance
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Mid-level Process Engineer specializing in pharmaceutical and chemical process optimization
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