Murli D. Purohit

SR. VALIDATION SPECIALIST with extensive experience in validation engineering and QA, specializing in the qualification of utility systems, controlled environments, and laboratory instrumentation within biotech and pharmaceutical sectors. Adept technical leader with proven success executing IQ/OQ/PQ validations, managing SOP documentation, and ensuring system compliance to cGMP, GxP, and 21 CFR Part 11 regulations.

Seasoned risk management expert that strategically implements CAPA protocols, conducts internal audits, and optimizes quality frameworks to uphold regulatory alignment and operational excellence. Exceptionally reliable collaborator with cross-functional expertise in risk-based validation, facility readiness, calibration oversight, and client-facing compliance services in high-stakes environments.

Senior Specialist - VaLogic Bio LLC - Frederick, MD

(2024-02)

• Drafted and refined SOPs, validation protocols, and reports to align laboratory procedures and system qualifications with regulatory standards across GxP environments.
• Executed calibrations and validations alongside metrology personnel, supporting pre- and post-protocol phases for diverse biotech instrumentation and systems.
• Performed and documented IQ/OQ/PQ for HVAC, WFI, clean steam, RO systems, and other utility infrastructures, ensuring facility and equipment compliance readiness.
• Validated cleanrooms, cold and stability chambers, incubators, autoclaves, bioreactors, and storage units per biotech industry requirements and cGMP expectations.
• Supported quality functions by developing and reviewing product specifications, test protocols, and analytical documentation to meet QA/QC standards.
• Conducted utility system qualifications integrated with Building Automation Systems, contributing to compliant production environments.

Quality Assurance Manager - VaLogic Bio LLC - Frederick, MD

(2022-05 - 2024-02)

• Led the development and maturation of internal Quality Systems covering documentation, deviations, CAPA, change control, validation, and training across regulated environments.
• Provided cross-functional GxP compliance support, establishing quality processes to ensure alignment with FDA, ISO, and client-specific standards.
• Directed internal evaluations of SOP adherence and quality inspection protocols, leading CAPA investigations and documentation updates.
• Trained project teams on quality procedure execution and compliance documentation aligned with evolving cGMP and CFR guidelines.
• Reviewed GMP documentation including IQ/OQ/PQ protocols and test reports, ensuring alignment with client schedules and regulatory standards.
• Collaborated with internal stakeholders and project leads to identify and resolve quality-related issues using risk management frameworks.

Senior Validation Specialist - VaLogic Bio LLC - Frederick, MD

(2020-02 - 2022-05)

• Led protocol creation and execution for validation studies across pharmaceutical and biotech sites, including IQ/OQ/PQ and computer system validations.
• Authored validation reports and deviation summaries for audits and ensured CI practices were upheld per 21 CFR Part 11 regulatory frameworks.
• Validated thermal units including controlled-rate freezers, LN2 equipment, and walk-in chambers using temperature mapping tools and documentation methods.
• Coordinated with cross-functional teams to adhere to both internal SOPs and client-specific procedures through comprehensive cGMP training and performance tracking.
• Operated GE Kaye ValProbes and TMO dataloggers for end-to-end thermal qualification and calibration services.
• Monitored SOP-driven compliance across validation lifecycles, enhancing documentation accuracy and client protocol execution outcomes.

Validation Engineer - ICOGPHS (For USAMRIID) - Frederick, MD

(2017-03 - 2019-12)

• Spearheaded validation programs, supporting FDA biomedical product approval by executing extensive IQ/OQ/PQ protocols for complex instrumentation.
• Executed risk-based approaches to equipment validation for advanced hematology analyzers, protein purification, and plethysmography systems.
• Authored comprehensive data analysis and validation reports in line with GLP and FDA regulations, including 21 CFR Part 58 and Part 11.
• Performed periodic reviews of legacy systems to identify qualification gaps, aligning revalidation plans with evolving SOP and FDA guideline revisions.
• Documented procedural logic and reviewed protocol content to ensure readiness for audits and cross-functional collaboration.
• Validated cell counters, LC instruments, spectrophotometers, and other systems integral to government-sponsored testing procedures.

Senior Validation Specialist - VaLogic Bio LLC - Frederick, MD

(2014-11 - 2016-12)

• Led validation lifecycle (IQ/OQ/PQ/PV/RQ) for bioproduction and analytical equipment including WFI systems, fermenters, depyrogenation ovens, autoclaves, pH meters, microplate readers/washers, particle counters, and glassware washers.
• Executed validation plans and authored documentation, including protocols, reports, and mapping studies for controlled storage units using Kaye Validator and RF ValProbe systems.
• Investigated equipment deviations, OOS results, and non-conformances, implementing corrective/preventive actions to improve process reliability and reduce recurring validation issues.

Quality Control Manager - Izeen Pharma Inc.

Quality Control Analyst/Manager - Capricorn Pharma Inc.

Senior Chemist/Supervisor - GPL Laboratories

Senior Chemist/Supervisor - Envirosystems Inc.

Senior Chemist/Supervisor - Chem Tech Inc.

Senior Engineer - Rajasthan State Electricity Board

Bachelor of Science (BS) - Electrical Engineering - University of Jodhpur