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Lead Technical Consultant Resume Profile

Professional Summary

  • Solid understanding in managing projects using a Software Development Life Cycle SDLC Planning, Development, Acceptance Installation, Operation, and Retirement.
  • Drove Excellence in delivery through Project Methodologies Waterfall, Agile and Scrum.
  • Proficient in creating and maintaining project charter, scope statements, plans, budgets, and schedules.
  • Seven plus years of experience in Pharmaceutical and Financial Industries Software Development, Web Development, Enterprise Desktop, Server Support and Release Management Projects.
  • Worked as Interim Program Manager established and cultivate relationships with senior IT and business executives to define and establish comprehensive solutions to meet market needs.
  • Publishing and conducting weekly communications/meetings detailing project status and progress, next steps, risks and issues to Stakeholders Internal External , Steering Committee, Business and Technical Team.
  • Certified SCRUM Master with SCRUM Alliance, proficient in reporting Velocity, monitoring progress burndown charts , retropsectives, mainting and trimming of product and sprint backlog and SCRUM coaching.
  • Knowledge of System Validation Skills, GxP GLP, GMP , 21 CFR Part11, Validation Protocol IQ, OQ, PQ .
  • Knowledge of Authoring, verifying validation documents, and executing test scripts for Pharma based companies. Such documents as Plans, Requirements, Qualifications, Matrices and Summary reports.
  • Strong Vendor Management skills, with onshore and offshore Vendor teams.
  • Strong analytical skills with thorough understanding of interpreting customer's business needs and implement them into application and operational requirements.
  • Proven track record delivering large, high level development initiatives - Managing complex deliverables from multiple on-site and off-site teams.
  • Provided technical expertise on information systems' designs and components to meet defined business needs and to ensure compatibility with enterprise and solution architectures.
  • Experienced with Release Management Activities
  • Experienced in identifying and managing project risks, issues, decisions, tasks, and change requests.
  • Experienced using project management and cost tracking tools MS Project 2010, Clarity PPM SAP, etc. .
  • Communicated succinctly, clearly, and effectively with business and technical people at all levels of an organization.
  • Proficient with effectively manage multiple tasks simultaneously across multiple projects with a geographically diverse workforce.
  • Managed teams in a highly matrixed and virtual environments.
  • Installed and configured commercial-off-the-shelf COTS packaged enterprise applications on client computers and application servers in a global environment.
  • Integrated new technology into manual semi-automated business processes.
  • Good understanding of large pharmaceutical R and D processes.
  • Ensured successful planning, coordination and execution of projects by maintaining strong controls in the applications development environment, including time, budget, risk, and quality management.
  • Knowledge of software virtualization technologies.

Technical Skills

  • Project Management Knowledge: Scrum Methodology, Agile and Waterfall Project Management, Change Management , Process Reengineering, Stakeholder Management, Budget Management, Process Maps/Road Maps and Vendor and Contract Management
  • QA System Validation Knowledge: GxP GLP, GMP , 21 CFR Part11, Validation Protocol IQ, OQ, PQ . Authoring, verifying validation documents and executing test scripts for Pharma based companies. These documents consisted of Plans, Requirements, Qualifications, Matrices and Summary reports.
  • Software: MS Project 2010 Server, Calrity PPM, SharePoint, SAP, Oracle, .Net 4.0 Framework, Unanet, Spectrum Treasury Management Software, Quest Software/Active Roles, ,Microsoft Office, Lotus Notes, Crystal Reports, PACS, Synapse, LastWord, , Lotus, VM, CSSD, MIS, MS Visio, Pacs, Landesk, Dameware, Patchlinks and Track IT.

Environments: Windows7, Windows XP, 2000, Server 2008R2 ,SQL2008, Active Directory, MCPs, UNIX, AIX / IBM S390, Exchange 2003, TCP/IP configuration, IIS configuration, Web Portal installs, Clustered and Farmed servers.

Professional Experience

Confidential

Project Manager

  • Manages relationships with internal and external service vendors to ensure superior service delivery for all application core technologies.
  • Managed external on-shore off-shore vendors.
  • Overseen Vendor selection by reviewing SOW's and RFP's for each project.
  • Authored Master Agreement that set Price Points for the selected vendor.
  • Gained the commitment of our vendors to assist and support the operations of the business.
  • Negotiated with vendor that helped both sides accomplish our goals.
  • Driven delivery through onshore/offshore vendor delivery model.
  • Initiated and drove process and system improvement opportunities to increase development efficiencies and quality and to decrease costs and time-to market, while advocating and encouraging nontraditional ideas.
  • Developed business cases to gain support, approval, and funding for projects.
  • Responsible for recruiting, training, developing, coaching and evaluating professional team to build a high performance team.
  • Held others accountable to established performance levels to achieve individual and group goals and maintain consistent practices across the organization.
  • Managed bi-annual release enhancements and CAPA related fixes to the Remetrex Safety and Product Quality Web Based Management systems.
  • Incorporated and coached SCRUM methodology SPRINT releases to continuously show the Business Stakeholders progress through the Development phases.
  • Worked with Product Owner and Team for Sprint Planning and Product Backlog creation and grooming.
  • Conducted Sprint Reviews demo which inspects the deliverables and gather feedback to adapt the plan for the succeeding Sprint
  • Conducted Sprint Retrospective with team and product owners to review and collaborate to improve processes for more successful and efficient Sprints.
  • Manged and reported Release Burndown and Velocity charts to measure the rate of deliver on running, tested features over time. Then used velocity to predict the rate at of future deliveries.
  • Conducted weekly team meeting and provided stakeholders with updates through project.
  • Conducted daily Scrum meetings with Product Owner and team members that captured 'What has been done', 'What is next to be done', and 'Are there any Impediments or Obstacles that will not allow team to achieve the current task'.
  • Managed the Cosmetovigilance Release project for the McNeil consumer which enhanced the Remetrex Safety System to enable Cosmetovigilance regulatory assessment and reporting.
  • Managed day-to-day operational aspects of the project within J J SDLC guidelines.
  • Daily Control and Monitor tasks such as Tracked project against plan, anticipated events which required contingency plans, recommend corrective action, and ensured stakeholders are kept informed.
  • Manage a team of IT CSV team in the development and execution of all validation documentation specific to the IT systems consistent with J J SDLC and IT Compliance standards.

Professional Experience Continued

  • Managed the Business to Business B2B connection requests and enhancements for external business partners, which entailed Business Risk Assessment, External Business Connection Security Agreement and Technical Questionnaire.
  • Provided Support for all Business to Business connections issues.
  • Followed J J SDLC process to ensure all project documents were aligned to support Project Deliverables.
  • Managed all SDLC and validation documents to be reviewed and approved in a timely manner to allow the release milestones and deliverables to be successful.
  • Managed the Vendor Development team to work with enhancements and new functionality that was incorporated into the existing system.
  • Aligned with Business Management to capture and finalize the requirements needed to be compliant with CAPA deliverables and new Regulatory protocols.
  • Worked closely with the CSV-QA Team to align all documents to the J J Consumer validation regulations and SOPs, which included review, authoring and approval of Compliance Analysis, Plan, URS, FRS, Test Protocols, Test Scripts, Exit Checklists, Summary Reports, etc

Confidential

Project Manager Business Planning Ops

  • Managed multiple projects using a Software Development Life Cycle SDLC Planning, Development, Acceptance Installation, Operation, and Retirement.
  • Managed day-to-day operational aspects of the project within MRL IT.
  • Documented and managed project scope, deliverables, risks, costs and budget.
  • Prepared project charter, plans at the task, milestone and resource level.
  • Publishing and conducting weekly communications/meetings detailing project status and progress, next steps, risks and issues to Stakeholders, Steering Committee, Business and Technical Team
  • Created a Release Management plan for ELN.
  • Planned and coordinated ELN releases builds and release schedules and provided capacity planning for all environments.
  • Ensured that the Change and Release Management policies were being adhered to by the technical analysts.
  • Worked closely with Business and Technical Analysts to coordinate releases.
  • Facilitate scrum ceremonies grooming, sprint planning, retrospectives, daily stand-ups, etc.
  • Enact change and continuous improvement increasing the productivity of Scrum teams by 15 and the quality of deliverables by 25 .
  • Empowered teams to self-organize and grow cross-functionality Protect team from over-commitment, manage backlog, prioritize resolution of defects/bugs as evidenced by the on-time delivery of major initiatives.
  • Met goal of addressing and resolving issues within 24 hours.
  • Manage the lifecycle of code development, from ideation to sprints to deployment Coordinate and manage code releases and shared APIs with other IT groups.
  • Communicate with other management, engineers, product managers and support specialists on product issues.
  • Track and communicate team velocity and sprint/release progress
  • Overseen the development of release and change management, activities, policies and procedures.
  • Directed and coordinated activities of project personnel to ensure project progresses on schedule and within budget.
  • Conducted vendor management, including reviewing vendor deliverables, holding vendors accountable for meeting timelines and milestones, etc.
  • Facilitated regular status meetings with project team.
  • Resolved and/or escalated issues in a timely fashion.
  • Built and maintained a positive, collaborative relationship across all disciplines, while ensuring that key business drivers are addressed.
  • Managed external on-shore off-shore vendors.
  • Help and coordinate vendor processes and methods to approve vendors.
  • Ensure to track, measure, report and evaluate vendor performance.
  • Troubleshoot all vendor problems and present to management as required.
  • Identify improvement areas internally as well as perform closely with all internal stakeholders to prepare solutions.
  • Identify and implement continuously enhance efficiencies associated with vendor management plus produce fulfillment.
  • Participate to formulate workflow processes, methods and policies for applying vendors.
  • Managed the Lab Wireless Upgrades: which provided the core infrastructure with the necessary technology to ensure the existing wireless network was able to supply coverage and redundancy for continuous business connectivity.
  • Managed the Cosmic Technology Process Mapping: Goal was to produce an architecture document that would Map Merck's Global Enterprise Reagent Management System ERM data flow. Implementing, identifying all and unknown interfaces.
  • Reviewed validation deliverables, based on system categorization and risk.
  • Knowledge of F.D.A standards, 21cfr11 procedures, Merck Information Security policies.

Professional Experience Continued

Confidential

Project Manager/ Lead Technical Consultant / Professional Services

  • Project Planning: Creation and management of a project plan throughout the duration of the project. This includes use of MS-Project, Excel, etc. in order to plan projects, monitor timelines, and coordinate deliverables.
  • Responsible for all phases of Spectrum Treasury Management Software deployment projects, from hardware specifications through software upgrade support.
  • Coordinate with external customer on gathering requirements and functionality that would best fit the business needs.
  • Customized Web Portals that allowed external end users to use financial software to manage personal finances, exercise options from 401k to trading.
  • Development: Work with developers, business analysts, and support staff in order to ensure that the solution meets the client's needs.
  • Organized and facilitated sprint planning, daily stand-up meetings, reviews, retrospectives, release planning, demos and other Scrum-related meetings.
  • Taught the team to create clear and concise epics/stories.
  • Instructed and modeled core Agile principles of collaboration, prioritization, team accountability and visibility ensured consistent application of scrum methodologies across the enterprise.
  • Worked with the engineering managers to identify cross-team dependencies and manage inter-team tasks Facilitated Scrum of Scrum for offshore teams in India.
  • Evangelized the benefits of Scrum to ensure its smooth adoption.
  • Assisted team with making appropriate commitments through story selection, sizing and task definition and participated proactively in developing and maintaining team standards, tools and best practices reducing development time by 35 .
  • Conducted Sprint Reviews demo which inspects the deliverables and gather feedback to adapt the plan for the succeeding Sprint
  • Conducted Sprint Retrospective with team and product owners to review and collaborate to improve processes for more successful and efficient Sprints.
  • Conducted weekly team meeting and provided stakeholders with updates through project.
  • Conducted daily Scrum meetings with Product Owner and team members that captured 'What has been done', 'What is next to be done', and 'Are there any Impediments or Obstacles that will not allow team to achieve the current task'.
  • Provided front-line client support for both technical and user questions regarding Spectrum. Business Analysis required working with a diverse set of users in order to understand their needs. Based on these requirements, determine how the users will use the system and what gaps may exist. This requires knowledge of the software and an understanding of how they work from Front to Back Office.
  • Knowledge of .Net 4. Framework, ensured that customer's infrastructure environment was properly configured for Code Access Security CAS , and validation and verification use and implementation of the Spectrum Treasury Management System.
  • Responsible for obtaining, pricing and implementing third party vendor software eg. Unanet, Goodsync and Crystal Reports to standardize with our software packaging.
  • Acquired an in-depth product knowledge in addition to technical knowledge concerning
  • software's database and architecture.
  • Managed on-shore and off-shore business and technical teams.
  • Ensure to collaborate with IT areas to assure vendor partners effectively manage plus contracts are completely leveraged.
  • Prepare processes for as well as manage analysis, selection and transition.
  • Monitor contractual agreements for all IT function's vendors.
  • Stimulate steady process enhancement to present increasing operational efficiency in entire business partner processes.
  • Support to explore expansion across new business lines.
  • Managed maintenance client relationships. This includes system support, new projects, system training and system upgrades.
  • Installed software on client servers navigate the existing environment to make sure that our software installs and performs to their specifications
  • Train technical staff at client site or via remote sessions on the installation process.
  • Installation of Prepared Release on Co-Location servers, provide access to FSS Support Person, who in turn works with the client on testing.
  • Liaise between client technical staff and FSS IT staff onshore offshore , relaying requests and solutions between the two departments.
  • Coordinate with other Professional Services staff on Upgrade work for clients.
  • Worked with the DBA's to upgrade to Oracle v.11g.
  • Client Communication: Act as the point person for communications with clients. This involves organizing conference calls and meetings as required.
  • Training: Coordinate and run training sessions as well as create material for end users.
  • Issue Management: Coordinate and monitor the issues list working with the Development Team in order to resolve the issues.
  • Troubleshooting: Coordinate troubleshooting efforts with myself and customers IT staff.

Professional Experience Continued

Confidential

Lab Support Engineer/ Project Manager/ Applications Services Associate

  • Project lead on wireless mobile workstations. Troubleshot wireless connectivity, made performance improvements and provided all maintenance work on 184 workstations..
  • Tracked all IT projects against technical project plan, anticipated risks and which required contingency and mitigation plans, recommend corrective action, and ensured stakeholders are kept informed.
  • Documented and managed project scope, deliverables, risks, costs and budget.
  • Prepared project charter, plans at the task, milestone and resource level.
  • Project Technical lead on Bluetooth balance systems. Configuration, test and deployment of 40 Mettler Toledo Bluetooth XP/XS Balances, Barcode scanners and printers. Conducted capacity testing to ensure that no interference or data loss had occurred.
  • Project lead on Deployment of VetPacs Digital imaging systems. Worked Sound Imaging to configure and deploy 2 Digital X-ray systems for lab. Provided Technical solutions for Data backup and PC hardware use.
  • Technical lead on Thinclient workstation deployment.
  • Contributed to capital and capacity planning decisions as well as new laboratory application requirements
  • Authored, verified, and executed validation deliverables for Pre-Clinical laboratory instrument systems. Such as Validation Plans, User and Functional Requirements, Installation Qualifications, Operational Qualifications, Performance Qualifications, Traceability Matrices and Validations Summary Reports.
  • Liaised between functional group, vendors and validation team for ongoing support and maintenance break/fix of new and existing systems while maintaining constant communication with Telecommunications, Desktop Integration Support, international sites, Server Support, and other IT organizations
  • Maintaining, administering and supporting a multi domain environment. Add and Delete and Move new user's domain access with Quest Software Active Roles.
  • Coordinated the development, implementation and validation for new analytical instruments, user applications, Laboratory Information Management systems and other software packages used in a validated state in accordance to 21 CFR Part 11 by Pre-Clinical areas
  • Knowledge of laboratory instruments such as HPLC, KTA chromatography system, Biomek Laboratory Automation workstations, Bio-Rad Chromatography and industrial microscopes and X-Ray systems.
  • Project Lead for Migration of high volume of systems over to new Trend Firewall Technology.
  • Provided daily Network / Computer / Desktop/ Scientific Instrument support for all Merck Research Labs.
  • Add, Deletions, Modifications of users in Active Directory.
  • Used proprietary software Merck Incident Management Merckury to track all help desk tickets.
  • Worked with outside vendors such as Agilent, Cybio and Zeiss to install new Lab equipment, software and system implementation.
  • Configured and Deployed new workstations/laptops to users with Merck's Lab image.
  • Removal and tracking of viruses throughout the Merck Plant.
  • Updated the MRL Lab PC Deployment Tracking database, and effectively track legacy system upgrades, replacements, and remediations.
  • Knowledge of F.D.A standards and procedures, Merck Information Security policies.

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