HAKIKAT TALWAR
MALDEN,MA
Summary
GxP IT and Computer System Assurance leader with a background in risk-based validation, data integrity, and regulated system lifecycle management across QC, manufacturing, and R&D environments. Partners with QA, IT, and scientific teams to deliver compliant solutions, strengthen change control, support audit readiness, and improve the implementation of laboratory and quality systems.
Overview
1
1
Certification
12
12
years of professional experience
Work History
Sr. QA CSV/CSA Specialist
Regeneron cell medicine (RCM)
Cambridge, MA
11.2025 - Current
- Develop and deploy a risk-based Computer Software Assurance (CSA) framework in collaboration with Quality and Compliance, aligning validation practices with FDA expectations, GxP regulations, and Lab Automation (E-Tech) while optimizing assurance activities through risk-based system impact assessment.
- Managed CSV/CSA lifecycle activities, ensuring ongoing GxP compliance with internal policies, procedures, and regulatory expectations.
- Led end-to-end change control management in Veeva QMS for instrument and equipment qualification activities(QC and Manufacturing), ensuring timely implementation and compliance.
- Lead Tech Ops Automation Tier 1 governance across QC, Manufacturing, and Facilities, providing technical oversight for CAPEX assessments, vendor projects, automation troubleshooting, instrument upgrades, computerized equipment lifecycle management, maintenance, calibration, and BMRAM activities, while coordinating cross-functional stakeholders to ensure compliant, reliable, and supportable technology solutions.
- Author and review validation and technical lifecycle documentation, including protocols, reports, risk assessments, and requirements, ensuring alignment with SOPs, system specifications, and predefined acceptance criteria.
- Collaborated with QC, Manufacturing, Facilities, Automation, QA, IT, and technical stakeholders to identify and mitigate compliance, Data Integrity, user access, validation, and security risks related to laboratory instruments and computerized equipment.
- Leading science-based biotechnology company known for discovering, developing, and commercializing homegrown medicines for serious diseases, including eye diseases, allergic/inflammatory conditions, and cancer.
Principal Validation Engineer
EDITAS MEDICINE
Cambridge, MA
03.2024 - 03.2025
- Led validation activities for GxP systems, fostering cross-functional collaboration, authoring and reviewing compliance documentation, supporting digital transformation initiatives, and ensuring regulatory adherence through risk-based Computer System Assurance (CSA) strategies and continuous process improvement in a regulated biotech environment.
- Spearheaded CSA-based digital transformation, reducing validation cycle time while enhancing regulatory compliance.
- Validated key GxP systems (OpenLab CDS, PLA, Peak Studio) and HPLC instruments, ensuring end-to-end system integrity.
- Led implementation of Veeva LIMS and Bartenders, automating QC workflows and improving compliance through streamlined labeling processes.
- Developed and implemented project management strategies for timely completion of validation projects using SmartSheets, ensuring alignment with regulatory requirements.
- Coordinated complex cross-functional projects with QA, IT, and business stakeholders, enhancing collaboration and project outcomes.
- Reviewed and approved critical GxP documents, ensuring audit readiness and procedural compliance across validation activities.
- Developed and executed test plans to verify software against Business Requirements, driving defect reduction and process improvements.
- Editas Medicine is a clinical-stage genome editing company that develops genomic medicines for serious diseases.
Principal Quality Data Engineer
SERES THERAPEUTICS
Cambridge, MA
08.2022 - 01.2024
- Oversaw quality assurance for GxP systems, led validation incident reviews, improved change control processes, and partnered with cross-functional teams to ensure compliance and system optimization.
- Deployed risk-based GxP systems, enhancing compliance oversight and strengthening quality at IT-business interface.
- Strategically upgraded Kneat and Batch Manufacturing Record and Analytics Management (BMRAM) platforms in collaboration with QA and subject matter experts, driving system performance and user adoption.
- Applied CSA principles to streamline IT change management processes, improving project success rates and overall efficiency.
- Conducted systematic audit trail reviews to identify gaps, elevating validation and documentation standards.
- Contributed to implementation and compliance of critical systems, including Benchling LIMS, Veeva QMS and QDocs, Kneat, BMRAM, and Ellab.
- Seres Therapeutics is a microbiome therapeutics company that develops treatments for serious diseases.
Senior Computer System Validation (CSV) Specialist
AKEBIA THERAPEUTICS
Cambridge, MA
07.2021 - 08.2022
- Managed IT system validation processes, authored policies, conducted risk assessments, led user acceptance testing, and coordinated IT efforts for regulatory inspections and readiness.
- Authored and managed IT system validation policies, ensuring all documentation aligned with regulatory requirements and organizational standards.
- Led risk assessments for system validation deliverables, ensuring compliance with regulatory requirements and industry best practices.
- Contributed to the successful validation of systems including ComplianceWire, UKG, Veeva QMS/QDocs, and Jira IT change control, ensuring that all systems met quality standards.
- Led user acceptance testing, developed execution training materials, and provided training to ensure successful implementation.
- Coordinated IT teams for inspection readiness and hosted vendor visits.
- Revised Standard Operating Procedures (SOPs) and Quality Plans to align with company standards and ensure continuous improvement.
- Utilized troubleshooting expertise to resolve complex validation issues, maintaining compliance with regulatory requirements.
- Akebia Therapeutics develops treatments for ischemia and vascular diseases.
Validation Lead Regulated System
IRONWOOD PHARMACEUTICALS
Boston, MA
01.2020 - 06.2021
- Ironwood Pharmaceuticals is a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases.
- Led risk-based IT change management for major system updates, ensuring compliance and reducing downtime during system transitions.
- Implemented robust data review solutions to improve audit accuracy and enhance reporting capabilities.
- Supported CAPA development to address data integrity gaps, driving sustainable process improvements and risk mitigation.
- Developed SOPs for QMS, EDMS, and Novatek LIMS, by optimizing system management processes and ensuring compliance.
- Refined IT SOPs to enhance operational efficiency and align with regulatory standards, and improve process consistency.
- Led risk-based IT change management for system updates, refined IT SOPs, optimized QMS/EDMS processes, and enhanced audit accuracy through data review solutions.
Validation Analyst, Development IT and Computerized Systems Validation
PACIRA BIOSCIENCES
Burlington, MA
02.2018 - 01.2020
- Led MasterControl and Tracelink projects, ensuring optimal resource allocation, effective timeline management, and project completion within set parameters.
- Authored comprehensive validation documents for MasterControl, SharePoint, and Tracelink projects, ensuring compliance and consistency across systems.
- Led validation projects, authored validation documentation, collaborated with management to set goals, and ensured project success through strategic planning and testing schedules.
- Consulted with management to establish clear validation goals and standards, aligning team efforts with organizational objectives.
- Orchestrated validation testing schedules with cross-functional departments, aligning project milestones with compliance requirements.
- Provided validation guidance, addressing potential risks and optimizing processes to enhance project outcomes.
- Once Flexion Therapeutics, Pacira BioSciences, develops and commercializes novel local therapies for musculoskeletal conditions, especially osteoarthritis.
Validation Lead, Par Pharmaceuticals
ENDO PHARMACEUTICALS
Chestnut Ridge, NY
03.2016 - 01.2018
- Endo Pharmaceuticals develops and markets generics and branded medications for patient care.
- Led cross-functional teams in defining system requirements, ensuring timely completion of projects while maintaining compliance with regulatory standards.
- Led cross-functional teams in defining system requirements, developing compliance reports, meeting project timelines, and supporting inspection readiness for legacy systems and equipment.
- Prepared compliance review reports for critical systems, including IMA Closing Machine Model F550, MVP Blending System, and Nanomill-60 Liter System, ensuring thorough documentation for regulatory compliance.
- Developed compliance and periodic review reports for legacy systems at New York sites to enhance inspection readiness and audit preparedness.
- Created User and Functional Requirements Documents retrospectively for the Brookfield Rheometer 3000, successfully routing for approval via MasterControl and ensuring thorough testing documentation.
Validation Lead
ABBVIE INC
Waukegan, IL
12.2014 - 03.2016
- Managed validation of critical systems, developed test plans, and executed regression testing to ensure compliance, performance, and alignment with regulatory standards for business processes.
- Led validation of ServiceNow Change Management to ensure compliance with industry standards and facilitate effective change control processes.
- Developed and executed comprehensive test plans and regression scripts using HP Application Lifecycle Management (HP ALM), securing robust system performance and minimizing downtime.
- Validated critical business processes and IT systems to enhance reliability and maintain compliance.
- AbbVie is a global biopharmaceutical company focused on researching and developing medicines, particularly in areas like immunology, oncology, neuroscience, and aesthetics.
Education
Master of Science (M.S.) - Biotechnology and Pharmaceutical Science
St. Johns University
Jamaica, NYBachelor of Science (B.S.) - Pharmacy
Kurukshetra University
Kurukshetra, IndiaSkills
- Computer System Assurance & Validation: Software assurance
- GxP IT & Technical Systems: GxP IT Governance, R&D Computerized Systems, Laboratory Informatics, QC Systems, Validation Lifecycle Management, System Integration, System Configuration, System Lifecycle Management, Computerized System Architecture, CAPEX Technical Assessment
- R&D / Laboratory Technology: LIMS, CDS, Laboratory Informatics, Veeva LIMS, Veeva Vault/QMS, OpenLab CDS, Biopharma Finder, Kneat, Ellab ValSuite, Azure RDS, Okta, Oracle SCM Cloud, BarTender, CMMS
- Compliance Frameworks, Data Integrity & Compliance: Data integrity
- System Lifecycle & Operational Resilience: Maintenance models
- System Integration
- Regulatory Compliance Leadership: Cross-functional leadership
- Regulatory Strategy Development: Strategic communication
Personal Information
Title: MS, PMP
Certification
Project Management Professional (PMP) certification, Lean Six Sigma Green Belt, Six SIGMA GLOBAL INSTITUTE, Google Project Management, COURSERA
Timeline
Sr. QA CSV/CSA Specialist
Regeneron cell medicine (RCM)
11.2025 - Current
Principal Validation Engineer
EDITAS MEDICINE
03.2024 - 03.2025
Principal Quality Data Engineer
SERES THERAPEUTICS
08.2022 - 01.2024
Senior Computer System Validation (CSV) Specialist
AKEBIA THERAPEUTICS
07.2021 - 08.2022
Validation Lead Regulated System
IRONWOOD PHARMACEUTICALS
01.2020 - 06.2021
Validation Analyst, Development IT and Computerized Systems Validation
PACIRA BIOSCIENCES
02.2018 - 01.2020
Validation Lead, Par Pharmaceuticals
ENDO PHARMACEUTICALS
03.2016 - 01.2018
Validation Lead
ABBVIE INC
12.2014 - 03.2016
Master of Science (M.S.) - Biotechnology and Pharmaceutical Science
St. Johns University
Bachelor of Science (B.S.) - Pharmacy
Kurukshetra University