RAMILA KHADKA
CARY,NORTH CAROLINA
Summary
Competent Engineering professional offering foundation in engineering project management and design. History of success in performing load and cost calculations and establishing clear parameters. Detail-oriented with strong knowledge of CQV and MES.
Overview
16
16
years of professional experience
1
1
Certification
Work History
CQV Engineer I
IPS
05.2022 - Current
- Trained and mentored competent and flexible workforce to meet project needs and promote positive work environment
- Performed preventative maintenance to keep tools and equipment functional
- Read and interpreted blueprints, technical drawings, schematics, and computer-generated reports
- Provided input to team lead regarding areas for process and procedural improvement
- Prepared action plans for problematic processes and assets
- Developed positive working relationships with stakeholders to effectively coordinate work activities
- Conducted research to test and analyze feasibility, design, operation and performance of equipment, components, and systems
- Documented and developed engineering procedures and processes
- Trained and mentored junior engineers, providing guidance and direction
- Led engineering teams to successfully complete projects on time and within budget.
Manufacturing Associate II
KBI
08.2021 - 05.2022
- EBR's, SOP's, MODA, HMI, PCS & Good Manufacturing Practices (GMP)
- Good Documentation Practices (GDP) and Good Laboratory Practices, manufacturing environment and facility
- Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations
- Basic technical writing with proficiency in Excel, PowerPoint, Word, and SharePoint, etc
- Works with PCS to develop detailed automation design(s) and specifications
- Made sure that products were produced on time and were of good quality
- Assembled products to meet production requirements and daily established quotas
- Followed safety protocols and utilized OSHA-approved PPE to foster a safe working environment
- Inspected finished products for quality and adherence to customer specifications
- Observed production deadlines with timely delivery of production goals and objectives
- Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products
- Investigated processing errors and malfunctions, resolving issues with minor machine repairs
- Primary point of contact for operator supports and issue resolution.
SPECIFICATION, RESEARCH ASSOCIATE
Clorox
02.2021 - 07.2021
- Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns
- Interpret and transfer data from supplier COAs into templates to create/ revise incoming raw material purchasing specification per 21 CFR part 11 regulations
- Experience of SAP database, Master Control, USP-NF or in-House SOPS
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations
- Helped team meet regulatory requirements by coordinating documentation and filings
- Gathered and organized information for research purposes
- Collaborated with leadership team to identify relevant questions and determine best methods of collection.
ASSOCIATE SCIENTIST
06.2020 - 09.2020
- GMP Quality Control Laboratory
- FDA regulates Documentation, Empower 3+ training
- Strong analytical skills with ability to calculate and evaluate findings
- Review QC data and accurately document protocols, report, specifications, etc
- Support equipment installation and process implementation of new equipment /processes relevant to manufacturing, packaging, and utility systems in regulated environment (FDA, DEA, OSHA, etc.) and strictly follow procedure
- Utilized UPLC methods to prepare samples for laboratory testing and analysis
- Produced statistical reports to correlate with laboratory research
- Conducted experiments in laboratory environment for product development purposes.
Development Analytical Scientist
Eurofins Scientific
03.2020 - 06.2020
- Conducted experiments in laboratory environment for product development purposes
- Documented changes during experiments, noting unexpected issues arising during research activities
- Also, utilized EMPOWER software to collect/analyze data/LIMS/ELE workbook
- Documented changes during experiments, noting unexpected issues arising during research activities
- Basic understanding of safety policies
- Self-motivated and able to follow instructions from project lead(s) and ability to work with multi-functional team to meet goals and achieve results
- Actively listened to customers, handled concerns quickly and escalated major issues to supervisor.
RESEARCH ASSISTANT
NORTH CAROLINA CENTRAL UNIVERSITY
08.2018 - 12.2019
- Collaborated with leadership team to identify relevant questions and determine best methods of collection
- Summarized search results by preparing written reports, graphs, fact sheets and tables
- Documented procedures and results with high degree of accuracy and precision
- Helped team meet regulatory requirements by coordinating documentation and filings
- Helped with large survey research projects and provided research support for data processing operations
- Supported research and development efforts to create new products, equipment, and processes
- Performed analytics (PCR, Western Blot, SDS-PAGE, ELISA, Protein purification, pH, TLC, HNMR, HVAC)
- Performed PCR, quality control on DNA samples, Centrifuge
- DNA Extraction and qPCR.
SEMICONDUCTOR OPERATOR
CREE INC
09.2007 - 01.2013
- Maintained knowledge of industry policies and procedures to set up and operate equipment safely
- Provided on-the-job training to newly hired workers and team members
- Operated technical and mechanical equipment and adjusted machine settings according to work cycles
- Performed quality assurance tasks to promote accuracy and minimize mistakes
- Performed equipment tests, calibrations, and repairs to keep machines running smoothly and prevent malfunctions
- Analyzed and measured final products with precision tools to confirm compliance to specifications and standards
- Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
Education
Bachelor of Science - Pharmaceutical Sciences, Chemistry
North Carolina Central University - Durham, NC
12.2019
Skills
- Precise Measurement
- Blueprint Design
- Site Visits
- Land Title Corner Locates
- CGMP Regulations
- Team Collaboration
- Work Management
- ISPE Baseline Guide 5 Commissioning and Qualification
- CQV experience in the Life Sciences industry
- Understanding of Good Manufacturing Practices (GMPs)
Certification
- Six Sigma: Black Belt, 08/2021
- CPR, 11/2021
Timeline
CQV Engineer I
IPS
05.2022 - Current
Manufacturing Associate II
KBI
08.2021 - 05.2022
SPECIFICATION, RESEARCH ASSOCIATE
Clorox
02.2021 - 07.2021
ASSOCIATE SCIENTIST
06.2020 - 09.2020
Development Analytical Scientist
Eurofins Scientific
03.2020 - 06.2020
RESEARCH ASSISTANT
NORTH CAROLINA CENTRAL UNIVERSITY
08.2018 - 12.2019
SEMICONDUCTOR OPERATOR
CREE INC
09.2007 - 01.2013
Bachelor of Science - Pharmaceutical Sciences, Chemistry
North Carolina Central University - Durham, NC
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