Nina Dellamonica
Lancaster,USA
Summary
Experienced Senior Validation Engineer with strong foundation in ensuring compliance and operational excellence. Adept at leading validation initiatives, optimizing processes, and ensuring regulatory adherence. Known for fostering team collaboration, achieving results, and adapting to dynamic environments. Key skills include quality assurance, risk management, and analytical problem-solving.
Overview
17
17
years of professional experience
Work History
Senior Validation Engineer
Biomerieux
07.2023 - 05.2024
- Developed and wrote validation Installation/Operation Qualifications (IQ/OQ) for equipment used in the manufacturing of medical devices
- Collaborated closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to establish validation plans for equipment as well as processes
- Executed validation team remediation activities for various equipment and processes
- Initiated, controlled, and executed validation processes and procedures for quality control of various test methods
- Collaborated in the preparation of the site’s validation master plan
- Prepared equipment for qualification studies and executed qualification and validation studies according to approved protocols and SOPs
- Developed and updated SOPs in accordance with cGMP regulations and trained the required users
- Managed validation activities which include developing documents, testing product, analyzing data, and summarizing reports
- Improved validation processes by implementing risk-based strategies and best practices.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Wrote and optimized test cases to maximize success of manual software testing with consistent, thorough approaches.
Senior Validation Engineer
Roche Molecular Systems Inc
04.2022 - 05.2023
- Developed and executed validation protocols for complex systems, ensuring compliance with regulatory requirements
- Initiated and completed OOS and CAPA investigations as required
- Led cross-functional teams to plan and execute validation activities, ensuring project timelines and deliverables are met
- Performed risk assessments and created validation strategies to mitigate potential risks
- Managed and maintained validation documentation, including protocols, reports, and standard operating procedures
- Communicated the quality status of materials and processes to the stakeholders
- Provided technical expertise and guidance to junior validation engineers, fostering professional development and knowledge sharing
- Supported cleaning, process, and test method validations
- Created rationale for TMVs
Senior Validation Engineer
Enhanced compliance Inc. RX
08.2018 - 12.2022
- Reviewed DHF (Design History File) documentation against clients QMS (Quality Management System) and applicable industry standards
- Acted as an SME (Subject Matter Expert) for product processing, cleansing, and steam sterilizing of medical device equipment
- Provided engineering and quality-related support as required
- Performed GAP assessment to ensure compliance with both EU and U.S
- Regulatory standards for various single-use and re-processable medical devices
Senior quality and Validation Engineer
Getinge Usa, Inc.
08.2018 - 04.2019
- Developed and implemented quality assurance strategies to ensure compliance with industry standards and regulations
- Led validation activities for new product development, including creating protocols, conducting tests, and analyzing data
- Collaborated with cross-functional teams to identify and resolve quality issues, driving continuous improvement initiatives
- Managed and maintained validation documentation, including protocols, reports, and standard operating procedures
- Provided technical guidance and training to junior engineers and team members, fostering a culture of quality and excellence
Re-processing and Val. Study Director
Nelson Labs
12.2015 - 04.2018
- Oversaw re-processing validation studies
- Managed laboratory analysts and ensured personnel working on studies assigned were properly trained
- Participated in and defended multiple studies during internal and external regulatory (FDA, ISO, etc.) audits
- Implemented quality control measurements and practices throughout the laboratory
- Assumed responsibility for analysis, interpretation, documentation, and reporting of data
- Understood raw data and interpreted calculations from data
- Ensured data integrity was maintained
- Worked with sponsors to ensure testing was done according to their specifications and within applicable standards
Lead Microbiologist
Intermountain Healthcare
02.2007 - 01.2016
- Developed and implemented microbiological testing protocols to ensure compliance with industry regulations and standards
- Oversaw a team of microbiologists, providing guidance and training to ensure accurate and timely testing results
- Managed laboratory operations, including procurement of equipment and supplies, maintenance of laboratory facilities, and budgeting
- Conducted research and analysis to identify and address microbiological issues, developing innovative solutions to improve product quality and safety
- Collaborated with cross-functional teams to develop and implement quality control measures, ensuring adherence to established procedures and protocols
Education
Master's - Healthcare management
Western Governors University
Salt Lake City, UT05.2012
Bachelors - Microbiology
Weber State University
Ogden, UT05.2010
Skills
- FDA
- GMP
- Data Analysis
- Data Collection
- Laboratory Equipment
- Process Validation
- SME
- ISO
- QA
- Microorganisms
- Project Management
- Microsoft office
- CGMP
- Leadership
- Statistical analysis techniques
- CAPA investigations
- Equipment qualification
- Quality management systems
- Environmental monitoring
- Test method validation
- ISO 13485 compliance
Timeline
Senior Validation Engineer
Biomerieux
07.2023 - 05.2024
Senior Validation Engineer
Roche Molecular Systems Inc
04.2022 - 05.2023
Senior Validation Engineer
Enhanced compliance Inc. RX
08.2018 - 12.2022
Senior quality and Validation Engineer
Getinge Usa, Inc.
08.2018 - 04.2019
Re-processing and Val. Study Director
Nelson Labs
12.2015 - 04.2018
Lead Microbiologist
Intermountain Healthcare
02.2007 - 01.2016
Master's - Healthcare management
Western Governors University
Bachelors - Microbiology
Weber State University
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