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ATANU SEN

Emeryville CA 1-305-***-**** adyzkk@r.postjobfree.com

Summary

Accomplished Validation Engineer with 7 years' experience catering to FDA and CLIA regulated healthcare and pharmaceutical Fortune 200 and 500 clients. Experience in cost-savings, production, manufacturing and providing technical deliverables. Successful in providing tactical and operational leadership, cleaning validation, computer system and software validation (CSV), IT interface and cloud based LIMS, CRM application validation, instrument and process/method validation, authoring impact & risk assessments, SOPs, IQ, OQ, PQ, implementation of new procedures. Skills

Equipment validation, Cleaning Validation, CSV, Software qualification Experience

VALIDATION ENGINEER 12/2022 - Current

Grifols Diagnostics - Emeryville, California

Validation activities related to FUE and computerized systems.

Validation plans, protocols, test scripts and reports.

Process design/control strategy development, technology transfer, equipment/utilities commissioning & qualification, process performance qualification (PPQ), continued process verification (CPV), process control/risk management, and product decommissioning.

Qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification), cleaning validation, and process validation.

Development and execution of IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.

Validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, routine monitoring, technical assessment reports

Cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization, validation using bioburden, conductivity, rinse and swab sampling

Temperature mapping qualifications

Periodic requalification and revalidation

Gap assessment/closure, corrective actions, and compliance remediation.

QMS: Documentum Compliance Manager (DCM)

VALIDATION ENGINEER 10/2019 - 11/2022

Abbott Laboratories - Santa Rosa, California

Cost-saving projects (~$500,000/year).

Software Validation

Lab instrument integration and interface with LIMS.

Implemented STARLIMS with PWNHealth Network.

New material qualification/verification during supply chain issues and vendor change.

Automation using Hamilton liquid handler.

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Validation & implementation of Alinity i instrument for COVID-19 antibody testing.

Validation of Enzyme Immunoassays on chemistry analyzers.

Technical SME for production floor troubleshooting.

QMS: Agile PLM

VALIDATION ENGINEER 05/2022 - 10/2022

Gilead Sciences, Inc. - Santa Monica, California

Validation of GMP computer server and cloud-based CRM applications.

Impact and risk assessments, validation protocols and other software design lifecycle (SDLC) documents.

QMS: GVault

VALIDATION SCIENTIST 04/2016 - 10/2019

Abbott Molecular Diagnostics - DesPlaines, IL

Cleaning Validation for lyophilizers, CIP, reagent filler, glove-box using bioburden, conductivity, rinse and swab sampling.

Qualification of manufacturing equipments - Pouch sealer, plate sealer, reagent filler.

Team member for Alinity m instrument CE mark acquisition.

Collaborated cross-functionally with Design transfer, QA & Manufacturing for process development and Technology transfer.

Thermal mapping (using Kaye Valprobes) of warehouse, water bath, refrigerators.

Training manufacturing team operators for scale-up and technology transfer.

QMS: Smartsolve

RESEARCH INTERN 05/2013 - 08/2013

St. Jude Medical Inc - St. Paul, Minnesota

Worked in R&D Science & Technology Group, with polymeric materials and analyzed supplier data in cGMP setting.

Analyze, interpret and conclude from material characterization using FTIR, MTS, SEM, Raman, DSC, TGA, DMA.

Interface with Operations, R&D, Regulatory, and business units to support material risk assessment. Education

Clemson University – South Carolina Doctor of Philosophy (Ph.D) Bioengineering, 05/2015

University of Missouri - Columbia Master of Science (M.S) Bioengineering, 08/2008

Publications

Ho-JoonLee, Atanu Sen, Sooneon Bae, Jeoung Soo Lee, Ken Webb ‘The effect of network composition on cellular remodeling in PEG-diacrylate/hyaluronic acid semi-interpenetrating networks'; Acta Biomaterialia (2014)

Jeremy Zhang, Atanu Sen, Eun-Hee Cho, Jeoung Soo Lee, Ken Webb ‘Poloxamine/fibrin hybrid hydrogels for nonviral gene delivery'; Journal of Tissue Engineering and Regenerative Medicine (2014)

Atanu Sen, Syed Barizuddin, Maruf Hossain, Luis Polo-Parada, Kevin Gillis, Shubhra Gangopadhyay ‘Preferential cell attachment to nitrogen-doped diamond-like carbon (DLC:N) for the measurement of quantal exocytosis'; Biomaterials (2009), 30 (8), pp 1604-1612

Certifications

Six Sigma Quality Control Green Belt, Clemson University 2011

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