Nick Lafronz-Emberger Email & Phone Number

Atlanta, GA, US

Hatboro, Pennsylvania, US

Tokyo, JP

New York, New York, US

• Planned and executed remediation work as a direct response to regulatory audits.
• Generated and conducted risk assessments for line, tank, and lyophilizer cleaning validation for regulatoryagency compliance.
• Generated and executed project plans for line and tank process and cleaning validation.
• Performed ADE cleaning calculations as a response to a regulatory audit. Identified impacted productsand wrote project plans for re-validation.
• Trended and evaluated hold times to eliminate gaps within documentation in support of remediation.

Tokyo, JP, JP

• Collaborated closely with Engineering/Process Engineering for activities and documentation related to Commissioning and Qualification programs during start-up and commissioning of the related equipment and utilities
• Defined CQV testing strategies through the implementation of validation and commissioning plans for cleaning of the fractionation and purification systems
• Functioned as the cleaning validation SME on cross-functional teams including Manufacturing, Warehouse, QC, and Micro departments
• Managed, scheduled, and executed cleaning development and validation plan for the Fractionation Department
• Drafted and executed unsoiled and soiled cleaning cycle development protocols to establish chemical wash out curves and cleaning cycle effectiveness
• Responsible for the support of development and completion of documentation on protocols, Validation Master Plans, and Validation Summary Packages

Heerlen, Limburg, NL

• Provide support and guidance for validation studies and quality systems for other North America facilities
• Successfully prepare API facilities for an FDA inspections, identifying quality gaps and validation concerns
• Provide feedback, recommendations, and training on Quality Systems
• Use Lean Six Sigma tools to support sites with Root Cause Analysis and process controls
• Prepare IQ/OQ/PV validation protocols and validation project plans for production and cleaning processes to comply with ICH Q7 and CFR part 110
• Prepare summary reports for validations and follow up with recommended actions as needed

Heerlen, Limburg, NL

• Performed IQ/OQ validation studies and PV on various equipment and processes
• Trained in LEAN 6 Sigma Green Belt; Applied tools and training to implemented process improvements
• Performed deviation studies and composed deviation and validation summary reports
• Installed and defined operating conditions for new equipment
• Troubleshot production issues to clearly define operating parameters and increase first time right production
• Developed training and SOPs for production operators

San Diego, California, US

Executed development protocols to ensure cleaning criteria were metReviewed developmental and verified data packs post executionPrepared data packs and summary reports for approvalPerformed rinse and swab sampling for COP cleaning development

Paris, France, FR

Executed development protocols to ensure cleaning criteria were metReviewed developmental and verified data packs post executionPrepared data packs and summary reports for approvalPerformed rinse and swab sampling for COP cleaning development

Researched new chemicals and presented findings on viability in the marketplace Investigated pricing and competitive markets for materials

London, England, GB

Formulated and created new motor oil blends

New York, New York, US

Developed sample batches of anti-perspirant aerosols and deodorants for product research, and consumer and analytic testing

Master Of Science (Ms), General Management

Bachelor Of Engineering (B.E.), Chemical Engineering