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about me

Experience

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CONTACT

about me

Lucky DAnkhra

Dedicated and results-driven professional in validation. complemented by a commitment to achieving excellence in every task undertaken. Adept Analytical validation, I thrive in dynamic environments that demand strategic thinking and effective problem-solving. Known for my strong technology and engineering background, I am poised to contribute my skills and passion to drive success in your esteemed organization."

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academic training

2018 - 2022

Certifications

BAchelors of science in Mechanical Engineering Tech

New Jersey Institute of Technology

• Assistive Design Certificate

• CAD and Digital Manufacturing

• Certified Energy Manager (CEM)

• Certified Manufacturing Engineer (CMfgE)

• Certified Quality Engineer (CQE)

• Certified Systems Engineering Professional (CSEP)

• Digital Manufacturing and Design Technology Certification

• Certified Airframe and Power Plant Mechanic

• FAA Certified Private Pilot

ExperiencE

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10/2021 - 05/2022

01/2022 - present

Lotte Biologics,USA, LLC

GENENTECH, VACAVILLA,CA

Validation Engineer

Validation Consultant/Intern

2019 - 2020

09/2022 - 12/2022

Bristol MYERS SQUIBB, EAST Syracuse, NY

Morphing airfoil design Technology

NJIT Engineers without Borders

Analytical Validation Engineer

Trainings

Quality Systems and Tools • 21 CFR Part 11,211 and 820 Annex 11 • cGMP • Change Control • Computer System Validation • Data Integrity (ALCOA and ALCOA+) • Drug Safety • Equipment Qualification/Requalification • FMEA • Inspection Readiness • ISO 14155: 2020 • Process Validation • Quality Assurance • Risk Management • Root Cause Analysis & CAPA • Six Sigma certification • Technical writing • USP 1058

Area of expertise

• URS/FRS

• IQAs, VQAs and EQAs

• Validation Project Plan

• Analytical Instrument SME

Hands on Instruments

• 7500 Fast PCR • Agilent Technologies Cary 60 • AKTA 150 • Beckman Coulter Vi-Cell • Biacore C • BioMEK • Bravo • Class A • Class B1/B2/B3 • Class C • FTIR and HPLC waters • GE Healthcare • iCE3 Analyzer • MicroSEQ ID • Osmometer • Polarimeter • Quant Studio 7 • TOC Analyzer • TruScan Raman • UV-Vis Spectrophotometer

• Laboratory Equipment/Instrument

• IQ/OQ/PQ protocol

• Qualification Summary Report

Software Skills

• C++ • Commissioning • Data Analysis • Design • Document control • Empower • FMEA • Infinity • Java • LIMS • Maximo • Microsoft Visio • MS Office Suite • Python • Veeva Vault • Intune • Visio • Power Automate • Project

Contact

LUCKY DANKHRA

"Ensuring Precision, Embracing Compliance: Upholding Excellence"

321-831-2452

Lucky.Dankhra@lottebiologics.com

649 N Salina Street, Syracuse, NY, 13208

Validation Engineer/Consultant

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The concept behind the design of the shape shifting airfoil is to create an airfoil is able to reconfigure itself to give optimal performance at all flight conditions. The morphing mechanism is to split the airfoil into parts to increase the wing area and, therefore, the lift. The mechanism works on the principal of change in the shape of the external wing, this airfoil features of camber morphing with multiple degrees of freedom. The shape morphing is enabled by the structure driven actuators or servos that help in changing the angle of attack relative to air velocity moving around the wing. Ts. The prototype shown is a 3D printed with PLA material and the flexible ribs made 3D printed TPU material.

• Author, review, and execute protocols for thequalification of analytical instrumentation in QC Laboratories, and supportmanufacturing areas. Author and review qualification reports.
• Support and coordinate qualification activitiesfrom equipment vendors qualification packages and serve a point of contactbetween vendor and Syracuse BMS customer.
• Author, review, and execute characterizationprotocols for process-related analytical issues. Author and review relatedreports. Provide support to preventative maintenance activities on analyticalinstrumentation in manufacturing, and laboratory areas (e.g. Total Organic Carbon (TOC) analyzer, pH and conductivity meters, and computerized analyticalsystems, Vi-CELL, Chromatography equipment, and electrophoresis equipments)
• Author and review equipment Investigationsproviding a thorough root cause analysis, making an impact assessment onvalidation and recommendations for effectiveness.
• Perform process troubleshooting in conjunctionwith QC Laboratory and Quality Assurance personnel. Identify root causeand recommend effective CAPA (when necessary).
• Provide on-call support, as needed, foranalytical instrumentation issues in manufacturing.
• Review standard operating procedures (SOP), andother cGMP documentation as required.
• Maintains Requalification schedule adherence andensures work is executed "right first time" in order to reduceequipment down time.
• Ensuring all qualification and requalification management tools/systems and documentation (SOPs, MBR's,) are accurate.

• Maintains familiarity with BMS directives andindustry guidelines on validation.

• Author, review, and execute protocols for the qualification of equipment used in laboratories and manufacturing. Author and review qualification reports.
• Track project completion and communicate progressfor laboratory and in-process instrument validation activities.

Roles and Responsibilites

Analytical Validation Engineer

First generation graduate as an Engineer and a Part time Private Pilot. Relevent Course work Include:--Quality Systems-Production process design -Manufacturing process-Chemical Technology-Mathematical Analysis for technoogy-Technical Writing-Industrial Statistics and cost analysis

Graduated from NJIT

• Development of Computerized Laboratory Instrument Validation and Qualification documentation including Validation Plans, User and Functional Requirement Specifications (URS/FRS), Risk Assessments, Design Qualification (DQ) Protocols, Installation and Operational Qualification Protocols (IQ/OQ), Performance Qualification (PQ) Protocols, Traceability Matrices, Configuration Specifications, and Validation Summary Reports. • Played a key role in the Validation Services department by executing thorough reviews of Standard Operating Procedures (SOPs). Authored Revalidation IQAs, VQAs, and EQAs, • Collaborated with laboratory Subject-Matter Experts (SME) to solve technical problems, identify worse case scenarios, and gain insight into the specific use of each instrument subject to qualification activities. • Drive completion of qualification activities onsite while working with cross functional teams and help with inventory management. • Perform requalification/revalidation activities with protocol execution, Record and Review Data using GMP and conduct investigation. • Ensure calibration of equipment used for validation activities is up to date and contribute to continuous improvement projects. • Communicate progress effectively and escalate technical and logistical concerns promptly. • Author of more than Qualification Documents 118 documents. • Performed GAMP Categorization and 21 CFR Part 11 and Annex 11 assessment for laboratory instruments. • Challenge equipment, system, or critical utilities to operate under extreme conditions. • Lead continuous project and process improvements within the validation department. • Demonstrated Quality tools/methodologies complaint investigation, process validation (IQ, OQ, PQ) and FDA standards, software validation, and instrument qualification along with completing all Data Integrity Gaps. Developed Risk Assessments, and testing protocol. • Support on-site event support, offering expert assistance for technological and computer-related inquiries, problem-solving, and seamless technology configuration.

Analytical Validation Engineer

• Authored Computerized and Non-Computerized Lab Instrument validation and qualification documentation including URS/FRS, Risk assessments, DQ protocols, • IQ/OQ/PQ protocols, Traceability Matrix, Configuration Specifications, Validation Summary Report • Utilize CAD drafting techniques (AutoCAD or AutoCAD LT) for designing functional layouts and equipment solutions. • Working on process improvements to bring the process in statistical control. • Ensured a safe working environment during implementation and qualification, recorded and reviewed data using GDP, conducted investigations when necessary, and created/reviewed documentation including IO/OQ/PQ for process equipment, validation protocols, SOPs, pFMEA, and dFMEA. • Served as a Subject-Matter Expert (SME) for data trending and provided manufacturing support during regulatory agency inspections. • Responsible for Change Control activities for Manufacturing Equipment and Instruments• Evaluated change control requests per SOPs, served as a Validation Services designee when needed, managed documentation and database systems, analyzed LIMS enhancements. • Participating in supplier quality reviews and managed product quality matrices such as PPM and other development programs with vendors to ensure products met in-house quality standards. • Facilitate QA oversight of commissioning, qualification, and validation activities to deliver early phase GMP manufacturing facility which includes raw material, Formulation and Drug Product • Implemented the Software Development Life Cycle procedures and conformance to 21 CFR FDA guidelines and Data Integrity regulations. • Conducted weekly production meeting and share information with the production team members about production goal, challenges, safety, and quality. • Knowledge of PMs on Manufacturing Equipment. Worked on time study of manpower and equipment and reduce time lag and increase production output.