PROFESSIONAL SUMMARY:

• Lab Informatics technical professional with 16 years of experience in supporting global Lab operations and Lab informatics applications, from instrument qualification, connectivity, trouble shooting, periodic maintenance and IT application administration, support.
• Experience in supporting globally distributed labs (clinical, process and microbiology operation) of key players in the Life sciences industry.
• Experience in instrument and LAC/E qualification (IQ/OQ/PQ) and Computer System Validation (CSV) of LabSystems (UV - VIS, FTIR, XRD, NMR, TOC, AA, SprayVIEW…) and lab informatics applications
• Experience in GxP regulation requirements in lab operations and ERES regulatory requirements.
• Experience in Installation and Qualification of Shimadzu HPLC/GCs (Installed more than 150 HPLC/GCs)
• Lead the Lab Informatics application support services in onsite and offshore model for the globally distributed labs.
• Configuration, administration and support CDS software systems for user management, project administration, instrument connectivity, hardware trouble shooting.
• Develop and upgrade CDS software systems in an integrated Enterprise landscape and deployment to 30 global sites.
• Experience in creating instrument (IQ, OQ, PQ) and CSV artifacts (VP, Test Plan, RTM, VR).
• Expert in consolidating Confidential instances and migrating sites to a new configuration, includes infrastructure, projects, raw data, LAC/E’s, instruments and users.
• Expert in review and update of the lab and IT operational procedures (SOP’s) for new software releases and instrument upgrades
• Release management including site kick off’s, collaborated with different platform teams, external vendors and CDS technical teams.
• Change management for equipment and Lab Informatics applications in compliant with GxP requirements
• Scheduled and on demand operating system/anti-virus patch testing, distribution management for CDS application and data acquisition servers (LAC/E)
• Instrument driver management includes release assessment, instrument firmware validation, testing and deployment across global locations.
• Design, develop, test, validate and deploy of new custom fields in Confidential CDS to meet the business requirements.
• Developed Confidential CDS and Lab CoE competencies by coaching/ junior resources.
• Expert in leading testing team for Lab Informatics application upgrade and release testing activities (unit, system, integration, regression).

TECHNICAL SKILLS:

Vendors: Waters, Thermo Fisher Scientific, Agilent, Shimadzu, Perkin Elmer, Dionex, Malvern

Instrument Types: HPLC, UPLC, GC, GC/MS, LC/MS, UV-VIS, FTIR, XRD, NMR, TOC, AA, SprayVIEW

IT applications:

CDS Systems: Confidential, Chromeleon, Confidential CDS, ChemStation, Class VP, LC/GC solutions

ELN: NuGenesis SDMS & LMS

LES: SmartLab (BioVia)

LIMS: LabWare, Darwin

Tools: HP ALM (QC), Team Foundation Server (TFS), ServiceNow, Remedy, MIDAS (Documentum)

PROFESSIONAL EXPERIENCE:

Confidential

Applications: NuGenesis SDMS, SmartLab

Technical Subject Matter Expert (TSME)

Responsibilities:

• Leading team technical front in delivering new and complex high-quality solutions to clients as per business requirements.
• Perform the impact analysis of the new vendor release of the Lab Informatics applications (CDS - Confidential, ELN - NuGenesis/SmartLab, LIMS - Darwin) on the enterprise ISA S95 landscape where IT systems are seamlessly connected to facilitate digital manufacturing.
• Analyze the new interface features, scientific calculations and infrastructure requirements. And translate them into necessary documentations for all system development life cycle phases (Analysis, Design, Development, Testing and Maintenance) .
• Implement the new vendor release in the global environments, perform the impact analysis, troubleshoot the installation technical issues, collaborate with the vendors and establish an error free deployment and upgrade process.
• Design and develop features related to new requirements (security, compliance, interface, custom fields) and create the respective design artifacts per the customer QMS process requirements.
• Assess the existing analytical instrument types (HPLC, GC, IR, UPLC etc..) and the impact of the operational instrument drivers by comparing the current and future state of the Confidential application.
• Review the scientific data (Chromatogram’s, IR chart etc..) to assess the instrument operation in the new releases and issue resolution.
• Develop Installation Verification Instructions (IVI’s) in the QC ALM to deploy the lab informatics application across 35 global manufacturing facilities.
• Review, create/update the operational artifacts (System Overview, Security Design, Configuration Specification, Disaster recovery) and application support procedures (SOP’s) for the current and new version of the lab informatics applications and maintain in electronic document management system, Regulus.
• Assess the new advanced analytical instrument compatibility, operation and control through Confidential CDS system.
• Review, create and update the testing artifacts (unit, integration and system test scripts) for each vendor release in QC ALM
• Develop and maintain the application installation modules in Team Foundation Server (TFS).
• Collaborate with the global external IT service providers and prepare a roll out plan to deploy the validated lab informatics applications to the 35 manufacturing sites.
• Interact with the onsite and offshore teams in translating customer requirements, delivery time lines, design and development of artifacts and collaborating with the globally distributed customer technical teams.
• Deploy the new releases to the global manufacturing sites per the agreed time line by executing the approved IVI’s and the quality deliverables.
• Provide IT application maintenance support to the end users across all manufacturing facilities by following the Incident management, service requests and change management processes in ServiceNow.
• Evaluate the operating system patches in the global infrastructure (Windows 2008, Windows 7, Oracle 12, Red Hat Linux 7.3) and share the recommendations to the local site manufacturing IT organizations.
• Install and upgrade the instrument drivers in the laboratory acquisition servers (LAC/E’s) to enable the analytical chemists and scientists to use the new features of the instrument, control and operate the new instruments from the Confidential application hosted in Citrix environment.
• Confidential projects (about 4 TB data across 30 instances) migration from Confidential 2 physical servers to Confidential 3 virtual server ( MF & DB) with Waters Migration Tool (WMT)
• Automation of Confidential server builds (MetaFrame Servers, File Server and Database Server), reduces the build process in the deployment phase.
• Automation of Confidential upgrade process for LAC/E’s with Microsoft SCCM tool and PowerShell scripts to deliver and upgrade multiple LAC/E at same time.
• Automate testing (unit, system, integration) and installation instructions using UFT tool to reduce the development and deployment time.
• Install and qualify a new analytical instrument (HPLC, GC, UPLC, MS, IR etc…) in the quality control (QC) laboratories by following the vendor provided operational procedures and approved IVI’s in QC ALM.
• Analyze the incident, problem, service requests, change requests trend by applying cognitive and analytical skills to improve the IT service operations.
• Create the IT service organization artifacts for the enhancement requests, Project Requirement Document (PRD), Ongoing Enhancement Form (OEF) with the application specific technical details.
• Evaluate the data migration tools for the technical feasibility in the enterprise IT landscape and for scientific instrument data collected from the analytical instruments.
• Perform data migration activities using the approved data migration tools by executing the IVI’s in ALM and troubleshooting the technical issues.
• Lead the team in completing global instances build (DEV, SND2, CFG, TST) by collaborating with the infrastructure (Windows, Database), service enabling teams (Citrix, software package delivery) and vendor teams (Waters, NuGenesis product team).

Confidential

Applications: LabWare LIMS, Prosoft, Trackwise and LabSystems (LC/MS, UV-VIS, FTIR, XRD, NMR, TOC, AA)

Project Lead

Responsibilities:

• Project lead for applications Empower2&3, LIMS, LabSystems, Prosoft and Trackwise systems.
• SPOC for the Technical issues.
• Efforts estimation for enhancement projects and up-gradation projects at Singapore site.
• Up-gradation of Confidential 3 from Confidential 2 system.
• Reviewed and updated all the design documentation and validation artifacts, as required.( Quality Assurance Plan (QAP),Requirements Specification (RS), Creating System Configuration Specification (SCS))
• Instruments (HPLC, UPLC & GCs) firmware compatibility evaluation and update
• Empower3 and ICOP packaging installation
• Projects migration from Empower2 to Empower3 system
• Qualification of LACE boxes.
• Instrument (HPLC, UPLC & GCs) and LACE connectivity testing.
• Completing the testing validation artifacts
• Administration of Confidential 2 application
• User access administration
• Confidential Project administration
• Database maintenance and project table space
• Validation and qualification of Confidential LACE boxes
• Instrument and LACE communication/access issues
• ICOP packaging and testing
• LabSystem’s support:
• Administration and support for all LabSystem’s applications (XRD, MNR, UV-VIS, FTIR, NIR, etc.)
• Validation of new LabSystem - PC configuration and coordinating with user in protocol preparation and performing the validation as per SDLC.
• User access administration and Data backup for all the LabSystems
• Incident and problems management for Lab System’s PCs and applications.
• Assist business units with for performance monitoring and annual periodic review (PRR).
• Incident and Problem Management.
• Change Control Management
• Managing the support team (assigning the task, helping in technical issues and s)

Confidential

Applications: Confidential CDS, LabC21and SDMS

Offshore Service Coordinator

Responsibilities:

• Manage and support Empower2 and Confidential CDS system at GSK R&D and GMS centers with 24/7 support
• SPOC for Technical issues with the application.
• Incident and Change Controls Management for Empower2.
• Problem management for Empower2.
• Coordinating with vender for tire 3 issues
• Designing of User interface
• Confidential Application administrator
• User access and Project administration
• LAC/E validation, operational maintenance and troubleshooting
• LabC21 Interface between Confidential CDS and LIMS.
• Microsoft monthly Hot-fix testing for LACE boxes
• Monthly Service Review Meetings with client
• Managing onsite and offshore team.

Confidential

Applications: Shimadzu Class Agent Manager, LC Solutions, GC Solutions & Class VP

Offshore Service Coordinator

Responsibilities:

• System study and requirements gathering
• Installation of Shimadzu new HPLC /GC instruments and qualification (IQ/OQ/PQ).
• Installation of Shimadzu LC/GC solutions applications and qualification (IQ/OQ/PQ)
• Implementation of projects, documentation & validation of systems and of test results
• Implementation of Shimadzu Class Agent Network in Server and client systems
• Provide to new recruits.
• Assignment and evaluation of work to the group
• Trouble-shooting, Validation and Calibrations of Chromatography Data systems
• Repair and maintenance of equipment in the client location
• Quality check-up and verification