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
