Validation Engineer - Amgen - Thousand Oaks
(2024-02)
- Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
- Creating new test methods and the required test fixtures.
- Creating all the required documents for qualification, validation and transfer of test methods.
- Create, revise parts and drawings using CAD software (SolidWorks Preferred).
- Perform data analysis using Minitab and interpret data.
- Performing and operating the tests required for qualification, validation and transfer of the methods.
- Creating training documents.
- Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.
Computer Systems Validation Engineer - PSC Biotech Corp
(2022-03 - 2023-11)
- Perform execution of CSV protocols
- Reports on automated tests and defects
- Changes made to existing processes
- Knowledge of SDLC (Software Development Life Cycle)
- Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT, test cases)
- Participate/support the planning, development, and implementation of computer systems validation documentation.
- Author, Review and or approve scheduled periodic reviews.
- Participate in computer validation project activities and create computer system planning documents and testing protocols.
- Understanding of workflows and regulatory requirements
- Provide range of support in a variety of CSV tasks
- Review and modify Standard Operating Procedures (SOPs)
- Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements.
- Develop and implement procedures for emergency shutdowns.
- Mentored engineers on the team with developing documentation and managing a project.
- Project Coordinator duties, responsible for all documents before go live date.
Validation Engineer - Ellab Corporation
(2020-11 - 2022-03)
- Assist in managing delivery of validation projects
- Author, review, approve and execute validation documentation including protocols, summary reports, procedures, other lifecycle documents.
- Performing calibrations and verifications in support of validation and engineering projects.
- Interfacing with customers to develop validation documentation, schedule projects, and communicate study results.
- Training new users and providing technical support.
- Oversee plant performance and oversee for improvement.
- Recording and reconciling project costs and information required for final billing.
- Analyze and interpret data from qualification studies if it meets acceptance criteria.
- Troubleshooting and debugging customer and Ellab equipment.
- Support and maintain the validation department equipment inventory.
Associate Engineer - Derm Cosmetiques - Agoura Hills
(2020-06 - 2020-11)
- Perform technical support when necessary.
- Understands test methods of physical characteristics and interprets relevant test data to improve the overall design.
- Monitor various projects and ensure effective performance of engineering processes and perform tests on the same.
- Attend meetings and interact with managers about consumer and other technical aspects such as NDA.
- Assists in the development of management information systems to aid in the control and development of company goals.
- Performing IQ,OQ, and PQ validations.
- Debug and troubleshoot issues with QA web applications.
Chemist - Puretek Corporation - Panorama City
(2019-06 - 2020-06)
Worked in a quality control lab for the first four months before transferring to R&D Lab.
- QC Lab executed several physical tests using equipment such as an IR scan, UV scan, viscometer, densitometer, and familiarity with HPLC and UPLC.
- Performed routine maintenance on equipment and determined when and what kind of maintenance is needed.
- Monitored batches in production
- In the R & D Lab I am creating batches and editing formulas to make shampoos, toners, body wash, lotions, daily microfoliant, lozenge, probiotics, vitamins, melatonin liquid, and energy shots.
- Entered data, verification, analysis, and technical reports for process monitoring.
- Highly proficient in good manufacturing practice (GMP).
- Performed, released, and stability testing in a GMP laboratory.
- Manage the equipment calibration program and Fill Line equipment
- Collect and document study details and results in lab notebook
- Review formulas while making large batches with the compounders.
- Work with the (R&D) team to transition small batches from the lab to full-scale production.
- Keeping backroom inventory neat and organized to ensure safety.
Lab Technician - Derm Cosmetiques - Agoura Hills
(2017-06 - 2019-05)
- Conduct chemical experiments under the guidance of the Head Chemist.
- Document test procedures and results and report the same to the Head Chemist for analysis.
- Coordinate, plan, and perform daily laboratory functions.
- Sole developer of the company's website.
- Served as a friendly, hardworking, and punctual employee
- Organized and prioritized work to complete assignments in a timely, efficient manner.
