• Designed dynamic Tableau and PowerBI dashboards for financial analysts and supply chain leadership to investigate and understand drivers within product categories and brand segments.• Partnered with analysts to document legacy processes, and prescribe/unify new business processes that enabled consistency and efficiency in financial reporting.• Used DVW Alteryx Connector to automate SAP ECC queries and codify/standardize complex FP&A financial close processes. • Coached analysts and contractors in SAP functionality, automation, data visualization, and good data science practices.• Supervised intern on FP&A functions and taught automation concepts using KNIME for capital expense reporting.

• Consolidated monthly and quarterly financials on $1.2Bn inventory of consumer products.• Contextualized management reporting to leadership, escalating and mitigating risks. Partnered with lines of business to drive financial commitments.• Budgeted and forecasted direct procurement spend for raw materials and finished goods. • Prepared Budget Variance Analyses and distilled primary drivers to share with business-partners and leadership.• Developed standard costing processes for finished good purchases from external manufacturers.• Automated monthly and annual fiscal activities using ETL, data wrangling and visualization tools (e.g., R/RStudio, Alteryx, and PowerQuery), which reduced cycle times, improved accuracy and contextualized data for greater business insight.• Established FP&A functions for the consumer health spin-off from JNJ. Defined functional requirements for financial consolidation tools and designed and executed UAT for system validation.• Audited J&J's enterprise function responsible for leasing agreements on medical devices and corporate vehicles.

• Coached contractors in writing protocols/reports, conducting investigations, and analyzing data, which improved the capability, productivity, and flexibility of a team supporting technology transfer studies of liquid OTC products.• Automated and validated a novel use of existing equipment for a filling campaign, resulting in a 50% increase to plant throughput. • Developed risk assessment methodologies for validation studies, leading to an efficiency savings equivalent to performing five validation studies on commercial equipment.• Championed an extensive investigation into raw material degradation impacting a product’s Critical Quality Attribute (CQA). Generated short-term action plan to meet product launch schedule and long-term project plan to remediate equipment to engineering specifications. • Implemented science-based control limits through stability studies and Continued Process Verification monitoring, which allow for continuous evaluation of process performance and potential quality risks.• Used regression analysis and ANOVA statistical tools to investigate a process shift, identifying a source of special cause variation in method preparation by the QC laboratory.• Self-taught expert in the Minitab macro language. Coded macros to rapidly perform monthly monitoring of critical commercial process data, allowing efficient and accurate trending of data.

McNeil Consumer Healthcare (January 2014 - December 2015): Hyde Engineering Team Site Lead• Advised Hyde E+C’s five consultants and co-managed 15 contractors responsible for development and validation of cleaning processes, playing a major part in the consent decree restart plan for the Fort Washington facility.• Directed consent decree project schedules for cleaning activities and coordinated cross-functional teams of engineers, operators, mechanics, and quality assurance inspectors in a 24/7 3-shift operation.• Created visual, metric-based tools, which enabled a large project team to focus on critical-path activities.• Benchmarked performance data to manage project timelines, improving cycle times and forecasting accurate project dates.• Designed cycles for Clean-In-Place and Clean-Out of-Place systems with “Faster Forward” principles, enabling rapid development of cycle efficiencies and flexible load patterns.• Created annual project lists, detailed scope of work proposals, interviewed contractors, and tracked project spend rates.Integra LifeSciences (March 2013 to January 2014): Cleaning Validation Consultant• Managed a four-person cleaning validation team for process equipment used to make 510(k) and PMA medical devices, remediating FDA Form 483 observations and culminating in the closure of a Warning Letter.• Partnered with QA and Operations to create easy-to-use cleaning record templates, which ensured the readability and right-first-time (RFT) completion of GDP records.• Defined and refined the strategy for a cleaning monitoring program for assessing long-term efficacy.• Authored and implemented change controls for process equipment, modernizing aspects to current best engineering practices.

• Commissioned and qualified cold-chain storage systems and integrated vial filling line (i.e., vial washer, depyrogenation oven, and filling machine) ahead of schedule, allowing early licensure of the new facility by Therapeutic Goods Administration (TGA).• Compiled a robust set of development data used in a risk-based process validation strategy, reducing the number of studies for validation while satisfying the compliance obligations.• Upskilled peers in documentation practices used in the real-time capture of critical execution steps during validation runs, resulting in greater right-first-time execution and sound validation packages for regulatory agencies.

• Managed a team of five validation engineers supporting four live-virus vaccine product franchises, enabling the team to perform initial and annual validation of manufacturing process equipment, in addition to supporting capital projects.• Obtained subject matter expertise in SIP, steam sterilizers, dry heat ovens, CIP and COP systems within aseptic manufacturing facilities, becoming an integral team member for validation studies, capital projects, audits, and investigations.• Led the validation strategy for a plant-wide vaccine manufacturing restart following a process non-conformance that impacted 10+ vaccine process franchises. Recognized by senior leadership for saving millions of dollars in cost avoidance.• Engaged with regulators during on-site inspections conducted by international agencies (specifically, FDA, MHRA, EU, TGA, WHO), demonstrating the satisfactory state of departmental validation systems while seamlessly supporting day-to-day activities.• Administrated the departmental document management system, QCTS – TrackWise. Liaised with IT on User Requirement Specifications (URS) for qualifying regulatory-driven and business-driven enhancements in compliance with Title 21 CFR Part 11.

• Generated Design of Experiments (DOEs), compiled data and analyzed results using regression analysis, whereby data served as an input to Functional Requirements Specifications (FRS) for an automated halogen lamp assembly line.

• Studied bench-top reactor parameters for altering the morphology of a biodegradable polymer, collaborating with research partners on desired characteristics for various implantable medical devices.