Vanessa Chiesl
Oceanside
Summary
Accomplished Validation Engineer with extensive experience at Genentech, excelling in regulatory compliance and process improvement. Proven track record of leading cross-functional teams to enhance product quality and reduce time-to-market by 20%. Strong problem-solving abilities and effective communication skills drive continuous improvement and successful project management.
Validation engineering professional with rich background in quality assurance and compliance. Known for driving successful validation projects and ensuring adherence to industry standards. Highly collaborative and results-focused, flexible in adapting to project needs and providing reliable support to teams.
Validation engineering professional equipped with solid foundation in process validation, quality assurance, and regulatory compliance. Known for strong focus on team collaboration, driving projects to successful completion, and adapting to evolving requirements. Skilled in developing and executing validation protocols, troubleshooting, and maintaining rigorous standards. Reliable team member with results-driven mindset and excellent problem-solving abilities.
Detail-oriented individual with exceptional communication and project management skills. Proven ability to handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for taking proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives.
Overview
25
25
years of professional experience
Work History
Principal Validation Engineer
Genentech
06.2019 - Current
- Led validation protocols for manufacturing processes, ensuring compliance with regulatory standards.
- Collaborated with cross-functional teams to identify and resolve validation discrepancies.
- Developed and executed comprehensive validation plans for new product introductions.
- Conducted risk assessments to enhance validation methodologies and improve operational efficiency.
- Reviewed and approved validation documentation, maintaining accuracy and consistency across projects.
- Spearheaded process improvement initiatives that streamlined workflows and reduced project timelines.
- Established strong working relationships with vendors ensuring smooth communication during project deployment.
- Generated validation plans for [Type] projects, setting specific temporal and budgetary goals for development and delivery.
- Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.
- Contributed to successful audits by providing detailed validation documentation and addressing any regulatory findings promptly.
- Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.
- Collaborated with cross-functional teams to resolve complex issues, resulting in reduced downtime and increased production output.
- Evaluated change control requests to assess potential impacts on validated systems, ensuring ongoing compliance with regulations.
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
- Streamlined the revalidation process by identifying opportunities for consolidation or elimination where appropriate.
- Provided technical expertise during the design phase of new equipment installation projects increasing efficiency.
- Developed comprehensive validation master plans to ensure alignment across all projects and stakeholders.
- Optimized manufacturing efficiency through the development of robust process validation protocols and execution of performance qualifications.
- Supported new product introductions by validating equipment, processes, software, and cleaning procedures as required.
- Assisted in creating a centralized repository for all validation documents streamlining access for future reference.
- Ensured regulatory compliance with FDA guidelines by conducting thorough validations and maintaining accurate documentation.
- Authored validation protocols for [Type] systems, verifying compliance with internal policies and external safety requirements such as [Area of Certification].
- Implemented continuous improvement initiatives for validation processes, leading to enhanced product quality and cost savings.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Drove corrective actions to accomplish project closure and recurrence control.
- Met tight deadlines to satisfy client demands and project timelines.
Validation Technical Manager
Genentech
10.2013 - 05.2019
- Led cross-functional teams to enhance product development processes and improve time-to-market.
- Implemented project management methodologies to streamline workflows and increase team productivity.
- Developed technical training programs for staff, enhancing knowledge retention and operational efficiency.
- Analyzed system performance metrics, driving improvements in software reliability and user satisfaction.
- Collaborated with stakeholders to define project scope, ensuring alignment with organizational goals and objectives.
- Mentored junior engineers, fostering skill development and promoting a culture of continuous improvement.
- Managed implementation of new technological improvements resulting in increased efficiency.
- Built trusted relationships with stakeholders through clear communication and collaborative problem-solving efforts.
- Completed projects [Number]% faster than expected, exacting cost savings of $[Number].
- Communicated cross-functionally with technology leaders across analysis, architecture, build, quality assurance, deployment and support teams on project execution.
- Developed technical strategies to align with business objectives, driving growth and innovation within the organization.
- Enhanced team productivity by implementing agile project management methodologies and streamlining workflows.
- Created comprehensive documentation of processes and procedures to ensure consistency throughout the department''s operations.
- Successfully managed multiple high-stakes projects concurrently while adhering to strict timelines and budget constraints.
- Finished projects up to [Number] months ahead of schedule and as much as $[Number]k under budget.
- Drove cost-saving measures by analyzing existing systems and infrastructure to identify areas for improvement and implement efficient solutions.
- Mentored junior staff members, fostering a supportive environment and promoting professional development.
- Led cross-functional teams for successful product launches, ensuring timely delivery and high-quality results.
- Communicated project status, delivering audience messages, and change management with clients.
- Managed budgets and resources effectively, optimizing resource allocation to maximize project outcomes.
- Conducted thorough risk assessments for each project phase, proactively addressing potential issues before they escalated into costly problems.
- Championed the adoption of cutting-edge tools and technologies to keep the organization at the forefront of industry trends and developments.
- Oversaw annual budget to handle supply, labor and maintenance needs.
- Developed and oversaw budgets for facilities and worked within cost restraints.
- Reviewed and oversaw construction and renovation projects.
- Prepared reports and schedules with accuracy.
Validation Engineer
Genentech
10.2012 - 10.2013
- Led validation projects ensuring compliance with industry regulations and quality standards.
- Developed and executed test protocols for product lifecycle stages and performance evaluation.
- Collaborated with cross-functional teams to identify process improvements and enhance efficiency.
- Mentored junior engineers in validation methodologies and best practices for documentation.
- Generated validation plans for [Type] projects, setting specific temporal and budgetary goals for development and delivery.
- Contributed to successful audits by providing detailed validation documentation and addressing any regulatory findings promptly.
- Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.
- Collaborated with cross-functional teams to resolve complex issues, resulting in reduced downtime and increased production output.
- Evaluated change control requests to assess potential impacts on validated systems, ensuring ongoing compliance with regulations.
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
- Developed comprehensive validation master plans to ensure alignment across all projects and stakeholders.
- Assisted in creating a centralized repository for all validation documents streamlining access for future reference.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Met tight deadlines to satisfy client demands and project timelines.
Validation Engineer
Genentech
09.2010 - 10.2012
- Established quality assurance protocols that improved overall product performance metrics.
- Streamlined validation procedures, optimizing test protocols to reduce time-to-market without compromising quality standards.
Validation Engineer
Mylan Pharmaceuticals
01.2007 - 06.2010
- Designed risk assessment strategies to mitigate potential issues during product development phases.
- Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
- Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
- Managed and inspected instruments and equipment for manufacturing [Product or Service].
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Developed validation protocols for software applications ensuring compliance with industry standards.
- Collaborated with cross-functional teams to enhance product quality and functionality.
- Developed comprehensive test plans, ensuring thorough examination of all critical system components.
- Authored validation protocols for [Type] systems, verifying compliance with internal policies and external safety requirements such as [Area of Certification].
- Drove corrective actions to accomplish project closure and recurrence control.
- Generated validation plans for [Type] projects, setting specific temporal and budgetary goals for development and delivery.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
Validation Engineer
Automated System Inc
03.2004 - 12.2007
- Assist in managing delivery of validation projects
- Author, review, approve, and execute validation documentation, including protocols, summary reports, procedures, and 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.
- Recording and reconciling project costs, and information required for final billing.
- Analyze and interpret data from qualification studies if it meets acceptance criteria.
- Troubleshooting customer and Ellab equipment.
Quality Engineer
Kimberly-Clark
12.2000 - 11.2003
- Developed and implemented quality assurance protocols to enhance product reliability.
- Conducted root cause analysis to identify defects and improve manufacturing processes.
- Led cross-functional teams in continuous improvement initiatives, boosting operational efficiency.
- Established quality metrics and monitoring systems to ensure compliance with industry standards.
- Trained and mentored junior engineers on best practices in quality control procedures.
- Collaborated with production teams to optimize workflows and reduce waste in operations.
- Evaluated supplier quality performance and recommended corrective actions as needed.
- Spearheaded audits to assess adherence to regulatory requirements and internal policies.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Facilitated training sessions for team members on quality management principles and best practices, enhancing overall competency levels within the department.
- Achieved significant reduction in waste, applying lean manufacturing principles to optimize resource usage.
- Initiated cross-functional team collaboration, integrating quality standards across departments to ensure uniformity in product excellence.
- Reduced product return rates, conducting detailed root cause analyses to identify and rectify manufacturing defects.
- Streamlined defect tracking process, enabling quicker resolutions and boosting customer satisfaction.
- Improved supplier reliability with thorough assessment and feedback mechanisms, fostering stronger partnerships.
- Fostered culture of continuous improvement, encouraging innovative solutions to quality challenges.
Education
Bachelor of Science - Chemical Engineering
Purdue University
West Lafayette, IN06-2000
Skills
- Regulatory compliance
- Process improvement
- Problem-solving abilities
- Task prioritization
- Self motivation
- Time management abilities
- Project management
- Continuous improvement initiatives
- Effective communication
- GMP compliance
- Critical thinking
Accomplishments
- Achieved [Result] by completing [Task] with accuracy and efficiency.
- Supervised team of [Number] staff members.
- Collaborated with team of [Number] in the development of [Project name].
Languages
Spanish
Native or Bilingual
Timeline
Principal Validation Engineer
Genentech
06.2019 - Current
Validation Technical Manager
Genentech
10.2013 - 05.2019
Validation Engineer
Genentech
10.2012 - 10.2013
Validation Engineer
Genentech
09.2010 - 10.2012
Validation Engineer
Mylan Pharmaceuticals
01.2007 - 06.2010
Validation Engineer
Automated System Inc
03.2004 - 12.2007
Quality Engineer
Kimberly-Clark
12.2000 - 11.2003
Bachelor of Science - Chemical Engineering
Purdue University