KAREENA TAURO

***** *** ***** **., *** H*, Fountain Valley, CA - 92708 aczlf1@r.postjobfree.com Cell: 425-***-**** SUMMARY

Validation engineer with 5+ years of experience in the pharmaceutical industry. Developed skills in validation while maintaining industry GMP and GDP standards in addition to gap assessment and remediation for various forms of equipment and processes. Displayed ability to adapt quickly to various tasks and operate under pressure while ensuring strong traceability of validation documents. Proven track record of creative problem solving and effective communication in an innovative FDA regulated environment.

TECHNICAL SKILLS

Validation: Planning and execution of IQ, OQ, PQ, CV, PV, PPQ, MVP and SOPs. Knowledge of cGDP, cGMP, cGLP, CCR, ECR, Deviations, IR, CAPA Processes and Regulatory Guidelines.

Cell culturing: Maintenance, freezing and thawing of EPCs, NHLFs, MRC-5s, SW-620s, SW-480s and A-549s. Cell counting and media preparation.

Tissue generation: Fibrin and collagen gel formation with cell embedment.

Microscopy: Bright field, inverted, phase contrast, fluorescence microscopy, laser confocal microscopy.

Advanced Laboratory Skills: Immunofluorescence staining, ELISA, immunodiffusion, chromatography and cell staining.

Basic Laboratory skills: Bacterial gene cloning, DNA isolation and purification, primer designing, PCR, recombinant protein expression and purification, gel electrophoresis and immunoblotting.

Computer skills: MS Office (Word, Excel, PowerPoint, Project), MasterControl Navigation, Database searches

(NCBI, PDB), alignment software (BLAST, CLUSTALW), drug-protein docking software (Hex), image editing software

(Image J), Photoshop.

LEADERSHIP SKILLS

Project management experience with consultant staff management, project setup, tracking and reporting.

Strong collaboration and interpersonal skills making for an invaluable team player.

Excellent analytical and creative problem solving ability with meticulous attention to detail.

Ability to communicate details effectively with strong presentation skills. EXPERIENCE

Standard Homeopathic Co. (SHC)/Hyland’s, Los Angeles, CA – Validation Engineer III February 2017 – To Date Engaged in equipment, process and cleaning validation at manufacturer of medicines. Position Highlight: Kick-started and streamlined Cleaning Validation activities to meet FDA standards. Equipment Validation:

Responsible for generating, overseeing and conducting validation activities for mixing, tableting and packaging equipment used for production of solid, semi-solid and liquid formulations.

Generation of high level project and equipment related master validation plans.

Responsible for gathering and properly leveraging documentation from equipment manufacturers in order to generate and execute validation protocols.

Generation, execution and final report submission of equipment installation (IQ).

Generation, execution and final report submission of equipment qualification (OQ).

Generation, execution and final report submission of equipment performance qualification (PQ).

Classes of equipment handled include but not limited to - powder and liquid mixers; tableting machines; pulverizers; filling machines; capping machines; banding machines; labelers; debossing machines and shrink tunnels.

Coordination of scheduling and deliverables for successful VMP application.

Creation and implementation of SOPs regarding usage of equipment.

Inspection on stability and integrity of tablets, compressed tablets, caplets, ointments and liquid formulation for equipment performance purposes and optimization of processes. Cleaning Validation (CV):

Generation and execution of cleaning cycle development and campaign cleaning processes.

Planning and execution of CV protocols and continuous monitoring of cleaning processes in a cGMP facility.

Optimization of manual cleaning processes to minimize time and cost.

Classes of equipment worked on include but not limited to - powder and liquid mixers; tableting machines; pulverizers; de-dusting machines; drying machines; production containers such as pots, drums, vessels, tanks, totes; production utensils; laboratory glassware.

Interpretation of PACE studies and application of multiple pharmaceutical grade detergents and combination detergents towards cleaning experiments and validation protocols.

Analysis on DI Water Systems, TOC Systems, Microbial testing.

Creation, revision and training of SOPs relating to cleaning of equipment. Process Validation:

Evaluation of potential process weaknesses and failures. Performing GAP analysis for documents and processes.

Generation and execution of validation protocols for new and existing manufacturing processes. Other:

Responsible for pre/post validation execution activities, including planning of capability and engineering/experimental studies, resolving of deviations and analysis of lab results for determination of limits and acceptance criteria.

Generation and execution of product hold time studies for determination of stability and expiry dates.

Initiation of change control processes for implementation of validation developments based on ongoing deviations, investigation reports (IR) and Corrective and Preventative Action (CAPA).

Serving as a liaison between R&D, Quality and Manufacturing to ensure adherence to regulations and SOPs.

Ensuring validation efforts align with up-to-date FDA guidelines.

Conducting design and engineering meetings and tasks for future production processes. SHC/Hyland’s via PSC Biotech – Team Lead & Validation Engineer II October 2011 – January 2017 Established provider of state-of-the-art compliance solutions to life sciences companies. Position Highlight: Managed consultant staff to meet critical project milestones. Optimized efforts to effectively achieve business goals.

Leading team of multiple members through continued client support for over 2 years.

Ensuring project and business goal alignment with stakeholders.

Interfacing with client subject matter experts in order to facilitate project timelines.

Preparing and managing project timelines for on-time execution of deliverables.

Managing individual engineers by utilizing each member’s unique strengths in meeting overall project goals.

Instructing and leading cross-functional teams on validation activities while meeting project milestones.

Training, developing, and supervising new engineers on day to day tasks.

Coordinating technical reviews, organizing data, and regularly communicating project updates to management. Prelude Corporation, Laguna Hills, CA - Engineering Intern June 2010 – December 2010 Start-up engaged in the development of a molecular diagnostic tool for the detection of pre-invasive breast cancer. Position Highlight: Exercised extensive research oriented and interpersonal skills.

Responsible for searching, reading, reviewing, and preparing written summaries and bibliographies of literature related to identification of patient sets, prognostic/predictive markers, and other information relevant to Ductal Carcinoma In Situ (DCIS).

Involved in developing partnerships and collaborations with pathologists, oncologist, surgeons and other experts in the field of breast cancer to aid in product development. RESEARCH EXPERIENCE

University of California, Irvine, CA - Research Assistant January 2010 – August 2011 At the Cardiopulmonary Transport and Tissue Remodeling Lab: Characterizing Cell Viability and the Impact of Oxygen Tension in a Cell Spheroid System.

Culturing cell spheroids of endothelial, fibroblast and tumoral nature in the range of 100-300μm radius at different oxygen concentrations to determine the oxygen diffusion limit and impact on the construct.

Conducting Live – Dead staining to study morphological and functional changes and behavior within spheroids.

Working extensively with wide field optical microscopy, confocal microscopy and two photon microscopy for imaging and tracking of cell spheroid systems.

PSG College of Technology, Coimbatore, Tamil Nadu, India Decolorization of Azo Dyes using Pseudomonas aeruginosa August 2008 – May 2009

Studying the increased capacity of P. aeruginosa to decolorize dyes; created a consortium of bacteria having an increased dye decolorization capacity for use in bioremediation of water contaminated with textile effluents. Effect of Single-Nucleotide Polymorphism (SNP) on Drug Binding with EGFR June 2008 – October 2008

Adopting Bioinformatics tools to study the change in drug receptor binding in the presence of an SNP; suggested use at diagnostic centers and clinical trials on patients having SNP to determine the efficacy of the drug. Cloning of Putative Flowering Genes in the Tomato Plant June 2007 – October 2007

Performing comparative analysis on available flowering genes and identified new candidate flowering genes by in silico analysis.

TEACHING EXPERIENCE

University of California, Irvine, CA - Teaching Assistant January 2011 – June 2011

Serving as teaching assistant to Introduction to Biomedical Engineering and Introduction to Biomedical Imaging. EDUCATION

Master of Science in Biomedical Engineering – University of California, Irvine September 2009 – September 2011 Bachelor of Technology in Biotechnology – PSG College of Technology, Coimbatore, India August 2005 – May 2009

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