Responsible for validation/qualification, maintenance of the validated state for Drug Substance manufacturing cleaning processes and equipment in a highly matrixed organization. Served as a technical SME supporting departmental functions; served as a validation specialist on cross-functional and multi-site teams. ● Streamlined GMP decisions by leading the implementation of Excel spreadsheet validation per network practices. ● Managed and ensured the validated state of equipment and processes at all stages of the validation lifecycle through protocol development and execution, summary report preparation and approval, periodic review and risk management documentation (PHA). ● Ensured on-time release of commercial and clinical products through management of cleaning validation across multiple production campaigns.● Ensured regulatory compliance and assessment of impact to existing processed through ownership of Change Control Records using the Trackwise and Veeva quality management systems. ● Streamlined contactor outputs by acting as single point of contact for validation contractors.● Improved operational efficiencies and effectiveness by distilling complex processes into readable, usable functional diagrams, flow-charts and narratives.Junior Developer (React JavaScript, Redux and Typescript)• Developed features for in-house web application (Barista 2.0) used by Process Engineering for tracking of pool volumes and campaign yields. Junior Developer (Pandas, scikit-learn, and matplotlib)• Developed features for a machine learning/artificial intelligence application AGORA (Automated Genetically Optimized Raman Analytics) used for analysis of in-process cell culture Raman spectra. • Configured a Sphinx site (hosted on GitHub Pages).

Responsible for establishing and maintaining the validated state for a suite of lab equipment in a QC lab environment. Wrote and executed commissioning and qualification protocols. Acted as a vendor liaison.● Improved validation execution time by 10% by Leading the commissioning and qualification of a new Kaye Validator 2000 for use in a QC lab environment.● Improved operational effectiveness by eliminated redundant and unnecessary process steps through the implementation of a Milli-Q Water System.● Increased bandwidth for ELISA by leading the commissioning of an ELISA plate washer.● Ensured correct operational usage while maintaining regulatory compliance by developing and delivering Standard Operating Procedures for lab equipment.

Equipment validation specialist in Quality Control• Established and maintained the validated state of QC lab equipment by performing Validation of Controlled Temperature Environments using the Kaye Validator 2000.• Contributed to the compliance of laboratory equipment by performing periodic review.

Micro-Virology Laboratories - QC Analyst (2004-2007)Abgenix - Environmental Monitoring Technician (2004 - 2004)Applied Bio Systems - Validation Associate (2001 - 2001)Caliper Technologies - QC Laboratory Tech (2000 - 2000)Inhale Therapeutic Systems - Clinical Manufacturing Operator (1998 - 2000)Alza - GMP Manufacturing Operator (1998 - 1998)

Media Prep and Support of a large scale DNA sequencing operation• PCR-sizing Assay in support of cDNA library production• Media kitchen: Preparation of growth media, solutions, buffers• Preparing PAGE gels in support of DNA sequencing operation