Vivian Aviles
South Chesterfield,VA
Summary
In my pursuit of career opportunities your company has become foremost. I consider myself to be a leader, therefore felt it imperative to investigate joining the ranks of your organization. This Resume provides an effective view of my career in where I have successfully engaged in roles of high complexity and responsibility for some of the most prestigious pharmaceutical companies. My experience background includes compliance roles as IT CSV & Compliance, Quality Assurance and Validation. My objective would be a career opportunity where my experience and education can be applied and where professional growth will be encouraged.
Overview
26
26
years of professional experience
Work History
QA validation Lead
Lonza Biologics, Inc.
Hayward, CA
08.2021 - 12.2024
- Directed validation activities for manufacturing equipment, utilities, and GxP computerized systems, ensuring adherence to regulatory standards and best practices.
- Administered requalification processes to guarantee ongoing validation and operational integrity of systems.
- Assisted validation team in developing strategies to improve processes and share best practices. Supported investigation of validation deviations and facilitated appropriate closure of corrective and preventative actions (CAPAs).
- Oversaw validation protocol reviews and summary report evaluations to guarantee alignment with regulatory standards and specifications. Led efforts to analyze associated data for compliance with acceptance criteria. Championed the development of comprehensive validation documentation.
- Assessed and validated qualifications of facilities, equipment, and utilities.
- Executed comprehensive qualification processes for computer systems to ensure compliance with industry standards.
- Conducted thorough validation of laboratory equipment to maintain operational integrity and reliability.
- Conducted comprehensive process validation to ensure compliance with industry standards.
- Performed detailed cleaning validation assessments, focusing on critical control points and quality assurance.
- Reviewed and updated validation SOPs to align with industry standards and best practices.
- Assessed change controls to ensure compliance with validation standards.
- Assessed periodic review and revalidation programs to enhance compliance and effectiveness.
- Collaborated with diverse project teams to ensure quality assurance standards were met.
- Collaborated with senior QA leadership to enhance operational efficiency through continuous improvement initiatives.
Manager, IT CSV
Intarcia Therapeutics
Hayward, CA
07.2019 - 06.2021
- Oversaw change control processes and CSV implementation for computerized applications and automation systems.
- Oversaw GxP and quality-focused strategies, providing essential support for the timely preparation and execution of lifecycle deliverables.
- Assessed and approved comprehensive validation deliverables, including user requirements, specifications, plans, protocols, SOPs, and summary reports, to maintain quality standards.
- Executed preparation and review of changes to validated systems through formal change control processes.
- Collaborated with Director of CSV to guarantee accurate execution of validation strategies.
- Oversaw compliance of all CSV deliverables with regulatory and quality policies and procedures.
- Analyzed and identified gaps in computer systems related to Part 11 and Annex 11, ensuring maintenance of validated status and data integrity.
- Contributed to investigations involving CAPA for GxP computerized systems to ensure compliance and operational integrity.
- Oversaw staff and contractors assigned to project teams, ensuring high-quality deliverables.
- Oversaw training initiatives for direct reports, ensuring access to essential tools and clear direction for successful validation task performance.
- Mentored and empowered direct reports to optimize teamwork and drive performance towards established goals.
- Conducted periodic performance reviews and formulated development plans to enhance employee growth.
- Facilitated regulatory audits and articulated company computer validation policies and procedures.
Senior Validation Engineer
PSC Biotech
Novato, CA
08.2018 - 07.2019
- Oversaw integration of artwork management system, ensuring alignment with organizational standards and user requirements.
- Executed comprehensive validation deliverables, including VP, CS, URS, IQ, OQ, PQ, TM, and VSR, and facilitated closure of related change control processes in TrackWise system.
- Designed and implemented comprehensive test script suites within HP ALM.
- Compiled and presented detailed weekly project status reports to project system owners.
Senior Engineer- IT Computer System Validation
Impax Laboratories
Hayward, CA
06.2015 - 08.2018
- Oversaw and directed LIMS project, empowering three implementation teams to achieve project milestones.
- Facilitated communication between business end-users and technical teams to identify user and system requirements.
- Assisted project teams in defining validation approaches and provided support throughout project lifecycles. Developed validation plans, test strategies, and test scripts. Created user acceptance checklists and compiled validation summary reports.
- Delivered weekly project updates to project system owners, ensuring alignment and transparency.
- Collaborated with systems owner and business analyst to establish pre-validation and validation environments for script execution.
- Evaluated and authorized validation protocol test cases before and after execution.
- Managed creation and closure of change controls in Trackwise system, ensuring compliance with regulatory standards.
- Executed internal computer systems validation SOPs and adhered to current regulations, including 21 CFR Part 11 and Annex 11, to review and approve validation protocols for Waters Empower software.
CSV Consultant
McNeil Pharmaceuticals, Inc.
Las Piedras, PR
01.2014 - 06.2015
- Facilitated development and execution of documentation to support CSV change control status within system development life cycle.
- Assisted in generating and executing documentation for Wonderware ArchestrA control system upgrade for Gelcap manufacturing machines. Supported development of retirement document, validation plan, user requirements, functional requirements, GxP risk assessment, technical specification, and traceability matrix.
- Evaluated and qualified local area network SCADA and PLC-controlled systems utilizing Allen-Bradley Rockwell Automation technologies.
- Oversaw comprehensive review and approval of validation documents to ensure compliance with CSV standards during Wonderware implementation.
- Analyzed and verified validation documents, ensuring accuracy and adherence to standards for new data center facilities.
- Delivered technical guidance and direction to resources during Wonderware implementation.
Quality Assurance, CSV
Janssen Pharmaceuticals, Inc.
Gurabo, PR
02.2010 - 12.2013
- Executed thorough quality reviews to maintain compliance with 21 CFR Part 11 requirements and GxP standards across all computer system validation procedures and documentation.
- Evaluated and approved CSV activities and documentation, ensuring adherence to compliance standards for spreadsheet validations and laboratory equipment operations.
- Oversaw audit processes and produced vendor assessment reports to ensure compliance and quality standards.
- Analyzed and verified critical validation documents, such as FAT, SAT, IQ, OQ, PQ, DR, and summary reports, to support the establishment of new parenteral facilities.
Validation Specialist, Instrumentation Area
Lilly Pharmaceuticals
Carolina, PR
01.2006 - 01.2010
- Oversaw auditing of laboratory equipment qualification documents, including IQ/OQ/PQ and final summary reports.
- Reviewed and confirmed accuracy of work orders and calibration records, enhancing reliability of maintenance documentation processes in Maximo.
- Scheduled and verified calibration and preventive maintenance activities to maintain compliance with established timelines.
- Organized monthly schedules for preventive maintenance of laboratory and manufacturing equipment.
- Conducted detailed IQ/OQ/PQ preparation for precise laboratory equipment calibration.
Validation Specialist
Wyeth Pharmaceuticals
Guayama, PR
01.2004 - 01.2006
- Executed implementation and validation processes for labware LIMS.
- Authored, initiated, and reviewed Standard Operating Procedures (SOPs) to ensure compliance with regulatory standards.
- Executed technical validation for configuration process protocols and test script execution within laboratory automation compliance enhancement and standardization project.
- Oversaw review and approval of validation documents authored by functional validation teams.
- Executed system administration duties and facilitated production support to ensure optimal performance in the instrument area.
- Assisted in documentation and data analysis for laboratory activities. Supported compliance with CGMP and CGLP standards. Operated laboratory equipment including HPLC, pH meter, Karl Fischer titrators, dissolution bath, and Millennium data acquisition system.
- Led qualification of HPLC system equipment by overseeing IQ, OQ, and PQ execution. Managed documentation and review of investigation reports to maintain regulatory compliance. Analyzed data to drive continuous improvement initiatives.
- Managed execution of IQ, OQ, and PQ for wave bioreactor, glucose analyzer, and refrigerator, ensuring optimal performance and reliability.
Validation Specialist
ICN Pharma
Humacao, PR
01.2003 - 01.2004
- Achieved successful analysis method transfer and validation support for cleaning processes, enhancing operational efficiency. Delivered effective validation of cleaning methods through proficient use of laboratory equipment, including HPLC. Resolved atypical and out-of-specification results through comprehensive investigations in raw material, finished water, and cleaning laboratories.
- Conducted thorough corrective and preventive actions to address issues identified during laboratory investigations.
Project Manager & Validation Specialist
Ortho Pharmaceuticals
Manati, PR
01.1999 - 12.2003
- Assisted teams in completing projects on schedule and within budget constraints. Supported project planning and execution by coordinating tasks and resources. Contributed to effective communication among team members and stakeholders.
- Coordinated project management activities at client site, focusing on resource allocation and scheduling for working paper initiatives.
- Directed and supported a group of 11 chemist validation specialists in executing validation protocols and maintaining quality assurance.
- Provided expert consultation and support to enhance resource effectiveness on working paper initiatives.
- Collaborated with cross-functional teams to implement validation protocols and enhance operational efficiency.
- Supported validation processes for transdermal patch system, enhancing product reliability and safety.
- Facilitated transfer and validation of analysis methods to enhance operational efficiency and data integrity.
- Documented and reviewed data analysis to ensure accuracy and reliability.
- Led investigation efforts for atypical and out-of-specification (OOS) results in laboratory settings.
- Conducted comprehensive documentation and review of data analysis processes.
- Facilitated laboratory analyst qualification processes and conducted comprehensive training for new personnel.
- Executed hands-on operation of various laboratory instruments to ensure accurate testing and analysis results.
- Facilitated process validation to ensure compliance with quality standards.
- Assessed and approved new quality standards revisions to maintain compliance and enhance finished goods quality.
- Conducted thorough review and update of SOPs to streamline operations and ensure adherence to industry standards.
Education
Bachelor of Science - Chemistry
Interamerican University of Puerto Rico
San German, Puerto Rico01-1998
Skills
- Quality Assurance (GxP Compliance)
- Computer System Validation (CSV/CSA)
- 21 CFR Part 11 & Annex 11
- Data Integrity (ALCOA)
- CAPA & Deviation Management
- Change Control Management
- SDLC & Validation Lifecycle (IQ/OQ/PQ)
- LIMS / Laboratory Systems Validation
- TrackWise / Veeva QMS
- IT Compliance & Risk Assessment
- Root Cause Analysis
- Cross-Functional Leadership
- Friendly, positive attitude
- Teamwork and collaboration
- Attention to detail
Languages
English
Spanish
Timeline
QA validation Lead
Lonza Biologics, Inc.
08.2021 - 12.2024
Manager, IT CSV
Intarcia Therapeutics
07.2019 - 06.2021
Senior Validation Engineer
PSC Biotech
08.2018 - 07.2019
Senior Engineer- IT Computer System Validation
Impax Laboratories
06.2015 - 08.2018
CSV Consultant
McNeil Pharmaceuticals, Inc.
01.2014 - 06.2015
Quality Assurance, CSV
Janssen Pharmaceuticals, Inc.
02.2010 - 12.2013
Validation Specialist, Instrumentation Area
Lilly Pharmaceuticals
01.2006 - 01.2010
Validation Specialist
Wyeth Pharmaceuticals
01.2004 - 01.2006
Validation Specialist
ICN Pharma
01.2003 - 01.2004
Project Manager & Validation Specialist
Ortho Pharmaceuticals
01.1999 - 12.2003
Bachelor of Science - Chemistry
Interamerican University of Puerto Rico