Validation Engineer

ANDREW LAPOINTE

774-***-**** **********@*****.***

Summary

Validation Engineer with three years of experience in the biopharmaceutical industry. Focus areas include

cleaning and process validation. Specific areas of expertise include:

CIP/COP Resin Lifetime

• •

Validation Lifecycle SIP

• •

I/O/PQ Process Performance Qualification

• •

Experience

Lonza Biologics, Hopkinton, MA 2010-Present

Validation Engineer II (promoted April 2013)

Provide validation support of clinical and commercial manufacturing with an emphasis on cleaning and process

validation. Projects and accomplishments include:

• Managed cleaning validation program under direction of the SME, successfully validating fermentation,

purification, and media preparation equipment CIP and COP cleaning procedures for five processes.

• Optimized approach to glasswasher validation through a risk-based approach to qualification,

decreasing time, resources, and allowing greater flexibility for manufacturing during routine operations.

• Generated and executed resin and membrane lifetime studies for over ten unit operations across three

products.

• Developed tool to simplify real time qualification tracking, project status, and data management for

validation projects.

• Assessed compliance gaps in validation policies and procedures by comparing documents to industry

guidance document ICH Q7.

• Continually improved cleaning validation philosophy by defining cleaning requirements for resin

contact equipment, aligning validation and product changeover TOC swab locations, implementing

continual monitoring of cleaning procedures, and strengthening OQ requirements for CIP cycles.

Validation Engineer I (Hired full-time April 2011)

Generate I/O/PQ protocols and final reports and support senior staff with various projects including cleaning

and process validation protocol execution, data compilation, and deviation and change control closure. Projects

and accomplishments included:

• Worked with cleaning validation SME to develop and implement clean hold study strategy using risk

based approach for the Hopkinton site.

• Designed and executed experiments to determine root cause of repeated bioburden failures encountered

during cleaning validation.

• Led client interactions to resolve major/critical deviations.

Validation Engineer Intern (via contract August 2010)

Executed autoclave, depyrogenation, and equipment steam-in-place (SIP) qualifications. Performed temperature

mapping for cGMP cold rooms and incubators. Compiled data for process, cleaning, and resin lifetime

performance qualification protocols.

Education

B.S.E., Chemical Engineering, University of Connecticut, Storrs, CT (2010)

Technical Summary

Kaye Validator 2000/KL, Veriteq, Laboratory Information Management System (LIMS), TrackWise,

Documentum, Aspen Plus

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