Anita Sah
Houston,Texas
Summary
Validation Engineer with hands-on experience in Computer System Validation (CSV), Commissioning & Qualification (C&Q), and Computer Software Assurance (CSA) in cGMP-regulated environments. Proven expertise in executing IQ/OQ/PQ protocols, data integrity assessments, and validation lifecycle documentation aligned with GAMP 5 and SDLC frameworks. Strong knowledge of 21 CFR Part 11, Part 820, and ALCOA+ principles, with demonstrated ability to identify audit trail gaps, access control risks, and data transfer vulnerabilities. Experienced in data transfer validation (manual, automated, and MFT-based systems) ensuring true-copy integrity and secure GMP data handling. Skilled in DIRA, change control, CAPA, and deviation management, with hands-on experience in Veeva Quality and TrackWise.
Overview
7
7
years of professional experience
Work History
CQV/CSV Engineer
Forge Biologics
Columbus, OH
06.2025 - Current
- Revised the cURS to align with updated system requirements and regulatory expectations.
- Drafted and executed IQ/OQ/PQ and addendum protocols for GMP equipment and systems, managing documentation in Veeva Quality Docs to ensure compliance with regulatory standards.
- Supported 21 CFR Part 11 and ALCOA+ data integrity compliance by verifying audit trails, user access, and electronic records.
- Coordinated cross-functional teams (Quality, IT, SMEs) for system integration with GMP network, Active Directory (AD), and data transfer via Diplomat MFT, facilitating seamless data workflows.
- Identified gaps in SOPs and led remediation activities, enhancing GMP and data integrity compliance.
- Supported change control activities, assisted in discrepancy resolution, and supported periodic review alignment.
- Performed verification of data transfer, true copy requirements (file size, format, timestamps), and secure storage on GMP network shares.
- Supported review of SOPs, WIs, and change controls (DCCs), identified gaps, provided feedback for GMP and data integrity compliance, and supported approval through stakeholder alignment.
- Contributed to data integrity risk assessments (DIRA) to ensure compliance with GAMP 5 validation methodology.
CQV/CSA Engineer
Alcon
Houston, TX
05.2023 - 05.2025
- Led end-to-end CSV/CQV activities for GMP systems ensuring compliance with 21 CFR Part 11, Part 820, and cGMP requirements.
- Authored and executed IQ/OQ/PQ protocols, URS, and RTM ensuring traceability and validation completeness.
- Performed Data Integrity Risk Assessments (DIRA) evaluating audit trails, electronic signatures, and user access controls.
- Managed change controls in TrackWise, performing impact assessments, securing approvals, and tracking CAPA to ensure compliance.
- Conducted gap analyses against regulatory standards, implementing corrective actions to address compliance issues.
- Collaborated with QA, IT, Regulatory, and Manufacturing teams to ensure validated systems met performance criteria and maintained inspection readiness.
- Supported backup and restore validation and disaster recovery testing for GMP systems managing electronic records.
Validation Engineer / Quality
Orchid Orthopedic Solutions
Bridgeport, MI
12.2021 - 03.2023
- Developed Validation Master Plans (VMP) and authored combined IQ/OQ protocols aligned with FDA and ISO 13485 requirements.
- Executed installation and operational qualification (IQ/OQ) ensuring systems met functional and safety requirements.
- Assessed impact of equipment and process changes in change control processes, determining revalidation requirements to ensure compliance.
- Documented deviations and performed root cause analysis to drive effective CAPA implementation.
- Conducted risk assessments (FMEA) to identify and mitigate potential failure points, enhancing system reliability.
- Ensured compliance with Good Documentation Practices (GDP) and internal QMS standards.
Validation Engineer
Immunomic Therapeutics
Rockville, MD
04.2020 - 11.2021
- Developed and executed IQ/OQ/PQ protocols for laboratory and manufacturing equipment.
- Executed CSV activities for GMP systems including LIMS, ensuring compliance with 21 CFR Part 11 and data integrity requirements.
- Managed deviations through root cause analysis and corrective actions to maintain compliance with validation procedures.
- Conducted audit trail and security assessments to ensure electronic records were secure, traceable, and compliant.
- Authored validation reports to document test results, deviations, and secure final system acceptance.
- Created and maintained traceability matrices (RTM) to ensure comprehensive coverage from URS to test cases.
Validation Engineer
Neurogene
New York, NY
07.2019 - 03.2020
- Drafted and executed IQ/OQ/PQ protocols to verify systems met operational requirements and regulatory standards.
- Performed CSV activities to ensure compliance with 21 CFR Part 11 and data integrity standards.
- Facilitated change control and validation activities for manufacturing systems in GMP environment, ensuring compliance and operational readiness.
- Collaborated with cross-functional teams to address validation issues, expediting system release and enhancing project timelines.
Skills
- Computer System Validation (CSV)
- Commissioning & Qualification (C&Q)
- Computer Software Assurance (CSA)
- IQ/OQ/PQ
- URS
- FRS
- RTM
- GAMP 5
- Data Integrity Risk Assessment (DIRA)
- Audit Trail Review
- Electronic Records & Signatures
- Access Control
- 21 CFR Part 11
- 21 CFR Part 820
- CGMP
- FDA
- Veeva Quality
- TrackWise
- Windchill
- Maximo
- BMRAM
- Box
- SDLC
- ALCOA
- Analytical Thinking
- Problem-Solving
- Attention to Detail
- Collaboration
- Communication
- MS Office
Timeline
CQV/CSV Engineer
Forge Biologics
06.2025 - Current
CQV/CSA Engineer
Alcon
05.2023 - 05.2025
Validation Engineer / Quality
Orchid Orthopedic Solutions
12.2021 - 03.2023
Validation Engineer
Immunomic Therapeutics
04.2020 - 11.2021
Validation Engineer
Neurogene
07.2019 - 03.2020