Daniela Escobedo Email & Phone Number

Downey, Ca, Us

Bethlehem, Pa, Us

-Reviewing turnover packages, identifying gaps to create RFIs, and construction walk-downs for new construction and development of a cleanroom space. -Conducting P&ID drawing walk-downs, reviewing completion of turnover packages and addressing discrepancies via exception reports.-Developing Commissioning & Qualification protocols for utilities inclusive of WFI, Clean Steam and Cooling Tower Water generation and distribution systems. Organizing submittals and uploading complete TOP materials. -Utilizing SAP to create Preventive Maintenance procedures and identify spare parts for all critical utilities and equipment, developing LOTO procedures for new equipment. -Working with vendors and contractors to assess and identify any discrepancies between work and PIDs.

Pomona, Ca, Us

As Key Account Manager responsible for maintaining and growing relationships with clients, generating proposals with budget estimates and checking in with direct reports.

Pomona, Ca, Us

Varian: Austin, TX 12/2021 – 03/2022-Sourced and led a team on various Validation projects to prioritize and meet deadlines.-Developed manufacturing processes to establish SOPs for chemical processes. Executed spreadsheet validations for manufacturing processes.-Designing equipment layout to accommodate smaller spaces and estimated production costs. Takeda: Thousand Oaks, CA 10/2019 – 11/2021-Developed and executed Commissioning & IOQs for utilities including process air, Nitrogen, DI water as part of a new cleanroom expansion. -Review of submittals and turnover packages while conducting construction walks-downs. -Developed and executed a validation plan, test protocol, URS and Functional Specs to qualify digital comparators inclusive of Gage R&R testing. -Execution of Validation activities for lyophilizers inclusive of I/O testing, alarms testing, PI data verification among other functional tests.

Thousand Oaks, Ca, Us

-Developed and executed commissioning plans for chilled water and plant steam with activities consisting of P&ID drawing walk-downs, review of TOPs and communicating with vendors to ensure specification conformance for new construction of fill line project. -Generated RTMs for fill line equipment including a depyrogenation tunnel, headspace analyzer, filler and lyophilizer. -Drafted User Requirement Specifications (URSs) for utilities. -Developed and executed a light mapping study for warehouse and freezer areas, identifying worst-case light intensity conditions and locations.

Blue Bell, Pa, Us

Atara Biotherapeutics: Thousand Oaks, CA 07/2018 – 10/2018-Execution of IOQs for warehouses, incubators, freezers and cryogenic units using RF valprobes and Kaye Validator temperature dataloggers and performing investigation of deviations for temperature excursions.-Conducted smoke studies for BioSafety Cabinets.-Reviewed executed protocols to ensure completeness and GDP compliance. McGuff Pharmaceuticals: Santa Ana, CA 10/2018 – 03/2019-Developed IOQ and Commissioning protocols for fill line equipment and utilities including vial washer, capper and clean steam among others. -Commissioning activities inclusive of drawing walk-downs, component verifications and operation for parts washer, autoclave as well as B&S fill line equipment; vial washer, tunnel, filler and capper. -Completed installation verification for compressed air, boilers, clean steam and WFI for commissioning. -Collaborated with vendors to review and walk-down sprinkler system to ensure adequate fire protection in cleanroom and facility.

Pomona, Ca, Us

Gilead La Verne, CA 06/2017 – Present• Execution of manufacturing equipment Qualifications for Validation.• Execution of PCS Commissioning protocols for fill line equipment.• Execution of Installation and Operational Verifications as part of commissioning activities for fill line equipment including freeze dryers.• Developing and closing investigations for testing outcomes found to be noncompliant to specifications.• Drafted Standard Operating procedures for freeze dryers. ProlactaCity of Industry, CA 11/2016 – 06/2017• Developed equipment validation documents for Installation, Operational and Performance Qualifications. • Generated and executed Installation and Operational Qualifications to validate Culinary Clean Steam System upgrade. • Developed and executed Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for proprietary manufacturing equipment. • Executed studies to evaluate methods and strategies for cleaning validation. • Assisting Validation in closing validation gaps.NantkwestCulver City, CA 09/2016 – 01/2017 • Performed Installation, Operation and Performance Qualifications of incubators, chambers, refrigerators, and freezers.• Developed protocols for temperature-regulated product-storage units: Chambers, Freezers, Refrigerators, and Incubators.• Execution of qualification activities by utilizing thermal mapping and Kaye Validator to record temperature information.• Utilization of KAYE Validator, TempTale, and Ellab temperature loggers to develop temperature profiles and to monitor equipment performance during normal use, worst-case operating conditions and disaster-recovery scenarios.• Analyzed temperature and CO2 data against specifications.• Investigated, analyzed and provided corrective actions for deviations.• Generation of reports to summarize activity results.

• Coordinated with Engineering, QA and other involved departments to ensure the successful completion of tasks for validation.• Executed and collected corresponding data for validation activities. • Formulated and edited reports containing statistical data analysis following validation activities.• Performed temperature mapping and formulated trending reports for equipment over extended periods of time. • Operated a variety of equipment including autoclaves and ovens while performing troubleshooting when necessary.• Ensured all validation activities complied with FDA and ISO regulations.

• Trained in chemical analysis of samples using ELISA for injection on GCMS instrument.• Maintenance of samples using LIMS software.• Calibrated lab instruments to ensure test result accuracy.• Collaborated with supervisor to restructure SOPs regarding chemical spills.• Prepared chemical reagents following SOPs for use in the lab.• Compiled reports containing toxicology and blood alcohol lab results for submission to district attorneys.• Handling and receiving of samples via a strict chain of custody.

• Performed research regarding solar cell manufacturing techniques and summarized findings in reports.• Formulated hypotheses and conducted laboratory research developing and testing antireflective coatings at UCLA Nanoelectronics Research Facilities. • Collaborated with engineers to ensure successful executions.• Led a team in projects regarding developments of proprietary production equipment and government collaborated research. • Interpreter for international business conference calls.