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● Supported development of best-demonstrated validation practices within the validation department, based on current industry practices and guidelines ● Responsible for onboarding new hires, contractors and mentoring junior members of cleaning validation team ● Supported continuous improvement within the validation department, as evidenced by decreased cleaning cycle time

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• Manage local validation studies and timelines, to capture any changes and new processes • Develop cleaning and validation SOP templates for production facilities to localize

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• Audited production and warehouse facilities to ensure they met ICH Q7, ISO9001and FSSC22K standards• HACCP trained; Worked with Food Safety Team to develop HACCP plans for site• Worked with vendors in order maintain and improve process equipment• Worked closely with production operators to ensure proper cGMPs were followed through production by review of batch records

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