Keertana Iyengar
Raleigh
Summary
Results-driven engineer with extensive hands-on experience in CQV execution, cycle development, and temperature mapping, alongside a strong commitment to continuous improvement. Broad exposure to analytical instrumentation, manufacturing equipment, and Quality Assurance facilitates effective collaboration with cross-functional teams while consistently delivering high-quality, GMP-compliant documentation through a structured and detail-oriented approach. Solid technical expertise combined with clear communication skills ensures reliable and timely results in regulated environments. Proficient in electronic execution systems, supporting end-to-end project deliverables including document drafting, execution, and quality review.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Engineering Consultant
Eli Lilly and Company
Durham, NC
09.2025 - 04.2026
- Designed and implemented a new Receipt Verification (RV) component onboarding process, introducing etching number traceability and integrating MRO-based checks to enforce functional testing and vendor compliance verification for all incoming parts
- Authored and reviewed validation protocols to ensure activities were executed in alignment with approved procedures and quality standards.
- Coordinated cross-functionally with Operations, Engineering, Quality Control, and Quality Engineering to plan and execute validation activities on schedule.
- Led cycle development and cleaning validation activities for parts washers to ensure compliance with site-wide validation strategy.
- Led and executed autoclave Performance Qualification (PQ) studies, including slow to heat, heat penetration, and dryness testing, to demonstrate consistent and compliant sterilization performance.
- Verified isolator performance through AFPT testing, ensuring adequate airflow dynamics to minimize contamination risk during aseptic operations.
- Executed Integrated Performance Qualification (IPQ) activities by verifying end-to-end integration of the MES system with manufacturing equipment, ensuring accurate data flow, recipe execution, and compliance with GMP requirements
- Client: Eli Lilly and Company
CQV Engineer
Sequence Inc
Morrisville, NC
06.2025 - Current
- Authored and executed commissioning test protocols for the COPW system, ensuring comprehensive and rigorous system testing to verify functionality, reliability, and compliance with design specifications.
- Collaborated with engineering and operations teams to resolve issues identified during testing and documented results in accordance with cGMP and company standards.
- Performed execution of commissioning test cases for the single-use bioreactor at the Sequence training facility.
- Developed and executed key project documentation for the UFDF skid, including the User Requirement Specification (URS), System Impact Assessment (SIA), and System Risk Assessment (SRA).
- Ensured that system design aligned with user needs and regulatory expectations, assessed system impact on product quality and patient safety, and identified potential risks with appropriate mitigation strategies.
- Collaborated with cross-functional stakeholders to gather input and drive alignment throughout the documentation and review process.
Technical Operations Shift Engineer
Merck
Elkton, VA
06.2024 - 05.2025
- Provide technical support for sterile manufacturing processes, including data analysis, troubleshooting, and report generation
- Lead deviation management processes, ensuring timely identification, investigation, and resolution of atypical events
- Execute CAPAs (Corrective and Preventive Action) to address non-conformances and prevent recurrence, enhancing overall compliance.
- Support change control implementation, ensuring alignment with regulatory standards and quality system requirements.
- Conduct root cause analyses and technical investigations, recommending and implementing corrective measures to enhance process robustness.
- Collaborate in process and equipment safety reviews, contributing to risk mitigation and ensuring compliance with cGMP (current Good Manufacturing Practices).
- Author and review technical documentation, including Standard Operating Procedures (SOPs), investigation reports, and deviation records.
Validation Co-op
Catalent Pharma Solutions
Harmans, MD
05.2023 - 08.2023
- Developed and implemented validation protocols for diverse equipment and processes used in upstream and downstream drug manufacturing, ensuring strict compliance with cGMP, GDP, and FDA regulations
- Regularly engaged with laboratory, manufacturing, and facilities teams to offer specialized guidance on equipment qualification.
- Identified and addressed conditions and practices with the relevant personnel, reporting the outcomes to management
- Provided assistance in equipment qualification and requalification, spanning computerized laboratory systems, processing equipment, temperature-controlled units, and other related systems
Lead Research Intern
Georgetown University Lombardi Research Center
Georgetown, DC
05.2021 - 08.2022
- Meticulously curated and refined the dataset to align with specific cancer types and related criteria.
- Actively engaged with the Research Lead and fellow interns, fostering a knowledge-sharing environment for best practices.
- Employed the gathered data to craft a sophisticated 3D model of an antigen vaccine, yielding substantial improvements in processing speed, data accuracy, and research outcomes.
- Demonstrated adept interdisciplinary collaboration throughout the project, ensuring a high level of professionalism and effective teamwork.
Education
BS - Biomedical Engineering
Penn State University
University Park05-2024
Skills
- MATLAB
- R
- Pymol
- SolidWorks
- Lean Six Sigma
- Aseptic Technique
- CGMP
- RCA
- CAPA development
- Deviation Management
Certification
- OSHA
- PCTB Pharmacy Technician
- Lean Six Sigma Yellow Belt
Timeline
Engineering Consultant
Eli Lilly and Company
09.2025 - 04.2026
CQV Engineer
Sequence Inc
06.2025 - Current
Technical Operations Shift Engineer
Merck
06.2024 - 05.2025
Validation Co-op
Catalent Pharma Solutions
05.2023 - 08.2023
Lead Research Intern
Georgetown University Lombardi Research Center
05.2021 - 08.2022
BS - Biomedical Engineering
Penn State University