Andrea Silva Lindsey

• Thermo Fisher- Senior Validation Engineer/ Project Manager

-Conduct careful review of validation protocols during development and post-execution to ensure adherence to regulatory standards.

• Seagen -Engineer

- Completed training and executed scanning of 11 buildings to create digital twin models using VLX3 equipment.

• VGXI -Automation Engineer

-Developed Automation MVP, Environmental Monitoring System URS, Building Management URS, RTM, SLRA

• Synthego-Senior Validation Engineer

- Authored and reviewed SOPs and CSV documentation for opening new manufacturing facility

• Abbvie-Senior Validation Engineer/ Project Manager

-Manage project and budget with client through monthly reports and weekly updates.

-Developed, executed, and/or reviewed Component Level Risk Assessments, System Level Risk Assessments, Functional and Design Specifications, Commissioning Test Protocols, Installation/ Operational Qualification Protocols, Installation/ Operational Qualification Report for Vision System Upgrades in Packaging Areas.

-Developed, executed and/or reviewed Test Script for Temperature Data Logger.

• Develop regulatory strategies/plans and compliance requirements and provide on-going support to cross functional project teams for regulatory issues
• Develop, execute and / or review studies for process revalidation strategies of Attribute and Variable specifications and their respective Performance Qualification and Characterization.
• Executed quality improvement research and studies.
• Played key role in new product launches by conducting thorough risk assessments and failure mode analysis, minimizing potential issues during production rollouts.
• Recorded findings of inspection process, collaborating with quality team to implement corrective actions.

• Develop, execute and/or review Installation Qualification Protocol, Installation Qualification Execution and Installation Qualification Report for Heat Sealers, Medical/Laboratory Refrigerator and Data Logger, Pull Testers, Isolators, Laminar Flow Hoods, Case Taper, Analytical Scales, Seal Strength Tester and other Custom Equipment
• Implemented New Manufacturing Layout, for new product process equipment.
• Enhanced product quality by designing and executing rigorous testing protocols for all manufactured items.

• Generated required inspection reports, defect reports and executed related inspection duties to ensure critical specifications were within specification to drive quality decisions
• Developed and conducted product sampling protocols to measure and evaluate component and final product inspections under specification requirements in manufacturing areas implemented within the facilities to determine product acceptability/rejection, PRB further inspection and/or immediate rework.
• Inspected quality of products, taking note of functionality, appearance and other specifications.
• Evaluated components and final products against quality standards and manufacturing specifications.
• Identified and helped resolve non-conforming product issues.
• Inspected outbound shipments and conducted random sampling of product quality.
• Trained and mentored junior inspection staff and interns to apply best practices and comply with quality control guidelines and regulations.
• Collaborated with production staff to establish and meet quality standards
• Assisted in training new Quality Inspectors, sharing knowledge of best practices and industry standards.
• Discarded and rejected products, materials and equipment not conforming with specifications.

• Developed First Time Quality (FTQ) documentation and Site Failure Modes and Effect Analysis (FMEA) through on site walkthrough assessments (Gemba) to identify and mitigate potential environmental, health and safety (EHS) issues into a 'Poka-yoke' or 'inadvertent error prevention' driven environment
• Established, managed and improve new and existing 'continuous' and 'one time' supplier accounts to ensure new systems, equipment and/or tooling implementation within Facilities.

• Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
• Evaluated new technologies and equipment upgrades to enhance overall process capabilities, ensuring market competitiveness.
• Develop, execute and/or review test method validation studies for final product inspection of Attribute, Variable and Destructive Test Method specifications and their respective Gage R&R studies.
• Write, review and approve process validation procedure documentation in support for IQ, OQ, PQ and/or PV activities for Computerized System Validations (CSV) implementation of new Cardiac Rhythm and Heart Failure (CRHF) Shield Assembly Manufacturing Cell Operating Systems (COS), such as: SOP , FTQ Verification, Software Backup and Restore Tooling and Fixturing , Verifications Preventive Maintenance /Calibration procedures and/or schedules, POD, SRS / URS, CSIOV, Traceability Matrix, Failure Modes and Effect Analysis.
• Provide support, train pertinent personnel and documented compliance verifications of Computerized Systems and/or equipment in for the CRT-P, Activa and Orion shields Assembly COS. Such equipment include: Fastener Resistance Spot Welder, Shield Laser Welder.