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Validation scientist skills for your resume and career
15 validation scientist skills for your resume and career
1. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Performed technical writing including documentation of test methods and validation protocols in compliance with FDA regulations.
- Maintained scrupulous documentation detailing validations/results included in formal presentation for FDA.
2. Chemistry
Chemistry is the branch of science that tells us about the composition, properties, and structure of elements and compounds. The processes these elements undergo and how they undergo change all come under the branch of chemistry.
- Authored and executed validation test protocols for new system software and chemistry database.
- Subject matter expert for the Department of Homeland Security on trace explosives detection and explosives chemistry with an emphasis on thermal analysis
3. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Developed, implemented, and maintained validation procedures according to regulatory requirements/guidelines (GMP, GLP, ICH, USP).
- Review and analyze documentation in the GMP Library.
4. Data Analysis
- Performed critical data analysis throughout product validation using statistical software packages and utilized product performance data to construct validation reports.
- Perform data analysis (including statistical probability) and prepare written reports/summaries from validation studies.
5. Troubleshoot
Troubleshooting is the process of analyzing and fixing any kind of problem in a system or a machine. Troubleshooting is the detailed yet quick search in the system for the main source of an issue and solving it.
- Designed and carried out laboratory experiments to troubleshoot product related issues.
- Analyze data and recommend procedures to troubleshoot manufacturing operations.
6. Method Validation
- Work Functions: worked on the method development of and cleaning method validations.
- Assisted colleagues with method transfers, method validations and method development.
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- Maintain and calibrate laboratory equipment.
- Developed and executed validation protocols for Laboratory Equipments (Chemical Laboratory - New Laboratory Incubator).
8. Lims
A LIMS - Laboratory Information Management System is a software solution to improve laboratory productivity and efficiency with modern support of laboratory operations to address the challenges of data and sample management, automation, and regulation of laboratories from around the world and thus maintaining workflows and standardized testing and reporting procedures.
- Reviewed and released all stability data via LIMS including documentation such as deviations, OOS, OOT, investigations, etc.
- Coordinate LIMS Sampling work lists and the request of Laboratory sampling kits.
9. Cleaning Validation
- Conduct Cleaning Validation of existing products on new manufacturing equipment (Coordination as Project Manager and execution).
- Assessed all new manufacturing equipment and cleaning procedure changes in production as impacted cleaning validation.
10. Test Methods
Test methods are the steps in which thorough testing is conducted in a laboratory setting.
- Developed assays/tests for raw materials or components and validated test methods for required properties.
- Observed all company MBR, SOP's, QAT and standard Test Methods.
11. Elisa
An enzyme-linked immunosorbent assay or ELISA is an examination or test to measure and detect a person's specific antigen, antibodies, and protein. This type of test will identify if the sample component is infected with a relative disease or condition such as HIV infection, anemia, Zika Virus, and Lyme disease with just a single experiment.
- Experienced scientist in standardizing ELISA assays for existing and synthetic molecules in cancer therapy for Personalized Drug Management.
- Process impurity analysis/CHO host cell protein contamination using ELISA.
12. QC
Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.
- Designed method that reduced processing time of key QC testing step from 1 week to 1 day and quadrupled throughput.
- Assisted in manufacturing QA assessment and investigation of Synchron QC lot discrepancy by evaluating trends and observing anomalies.
13. Method Development
- Developed swab sampling techniques based on API and detergent residue tendencies and applied results to new method development of recovery studies.
- Performed chemical extraction methods, prepared necessary solutions, weighed client provided compounds, and assisted in method development.
14. CAPA
- Participate as Auditor and Lead Auditor CAPA system utilization in the Internal Audit Program.
- Conduct investigation process through CAPA system when adverse conditions are found.
15. Statistical Analysis
- Perform statistical analysis of retrospective and prospective validation data.
- Supported validations and process improvements, performed statistical analysis on critical process parameters and quality attributes utilizing SAP statistical software.
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What skills help Validation Scientists find jobs?
Tell us what job you are looking for, we’ll show you what skills employers want.
What skills stand out on validation scientist resumes?
Sara Tedrick Parikh Ph.D.
Associate Professor, Faculty, Psychology and Counseling, Caldwell University
-Social Scientists are trained to understand, predict, and interact with other people, and every business in the world involves interacting with people!
-Many social scientists have work experience as babysitters, camp counselors, tutors, or resident assistants. These jobs use many communication, empathy, and management skills that could be relevant to jobs such as case managers or group home assistants. To really capitalize on these widely applicable experiences, tailor your resume for each job you apply for. Identify key skills by carefully analyzing the job ad and looking up descriptions of similar positions, then think carefully about how your paid and unpaid experiences have prepared you for the position.
-Remember that your resume is used to get you the interview, where you can talk in more detail about skills and experiences relevant to the job. Do not feel pressured to fit everything relevant into the resume, but have someone else read the resume and job ad side-by-side to see if you have clearly made your case.
What soft skills should all validation scientists possess?
Rev. Grace Song
Won Buddhist Studies Department Chair, Won Institute
-Good time management skills
-Ability to resolve conflicts
-Self-aware
-Values collaboration
What hard/technical skills are most important for validation scientists?
Rev. Grace Song
Won Buddhist Studies Department Chair, Won Institute
-Certificated mindfulness instructor
-Experience running retreats/workshops
What validation scientist skills would you recommend for someone trying to advance their career?
Scott Johnson
Professor and Director, University of Maine
What type of skills will young validation scientists need?
What technical skills for a validation scientist stand out to employers?
Dr. Joey Neilsen
Assistant Professor, Villanova University
List of validation scientist skills to add to your resume
The most important skills for a validation scientist resume and required skills for a validation scientist to have include:
- FDA
- Chemistry
- GMP
- Data Analysis
- Troubleshoot
- Method Validation
- Laboratory Equipment
- Lims
- Cleaning Validation
- Test Methods
- Elisa
- QC
- Method Development
- CAPA
- Statistical Analysis
- Technical Reports
- Liquid Chromatography
- IQ/OQ/PQ
- Iq Oq Pq
- Risk Assessments
- Microbiology
- ICH
- Validation Studies
- Validation Procedures
- GLP
- Summary Reports
- Gap Analysis
- Analytical Methods
- Dosage Forms
- QA
- PLC
- DOE
- USP
- Validation Program
- Process Validation
- R
- CIP
- Acceptance Criteria
- GC
- Statistical Tools
- Electrophoresis
- Validation Projects
- OOs
- Regression
- FMEA
- Validation Reports
- TrackWise
- Sterilizers
- API
Updated January 8, 2025