QUALIFICATIONS SUMMARY

• IT professional with 9+ years of experience in PLM
• 6+ years of experience as a Business / Systems Analyst and Software Validation expert in PLM application projects, for major Medical Device and Pharmaceutical industry customers
• Extensive experience in IT solutions for PLM projects, specifically Siemens PLM
• Expertise in Siemens PLM application, Teamcenter Unified, Teamcenter Express, with 9 years of experience
• Highly proficient in Teamcenter (Unified Tc9.1.2.2, Tc2007.1.7, Tc2007.1.5; Engineering v10 SR1 / 2007 MP2; Express V2, V3, V4)
• Experienced in Teamcenter upgrade from Unified 2007 to Unified 9.1.2.2
• Briefly worked with Dassault Systems' Enovia
• Experience in Agile and traditional Waterfall SLDC methodologies
• Proficient in documentation skills for FDA compliant applications used in medical device and pharmaceutical industry
• Proficient in the use of MS Office tools, like MS Word, MS Excel, MS Powerpoint, MS Project and MS Visio
• Proficient in processes for software quality analysis and validation, employed by healthcare, medical device and pharmaceutical industry customers
• Extensive knowledge of cGMP and GDP
• Extensive experience in 21 CFR Part 11 compliant quality assurance and in - depth knowledge of 21 CFR Part 11 guidelines
• Proficient in the use of HP Quality Center (versions 10 and 11)
• Experienced in MS Visual Studio 2005 and 2008, Eclipse 3.2
• Programming languages known: C, C++, Core Java, Java Swings, JSP, HTML, XML
• Very strong communication skills and ability to work independently and as a part of a team.
• Very strong technical writing skills, good report writing abilities

Business Technical Analyst

Confidential, Round Lake, IL

Responsibilities

• Analyze, define, design, and document business flows and processes
• Provide consultation to customers on business process redesign.
• Assist in the development of system documentation and training materials as well as training processes. Train others as appropriate on specific area of business or systems expertise
• Gather, understand and document business objectives, specifications and requirements
• Develop and execute unit/system test cases, scripts and plans.
• Define and articulate business rules required for data accuracy and consistency. Identify and resolve data quality issues. Act as the primary contact for the data management process between IT developers and the business.
• Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project.
• Identify and understand issues that may impact day-to-day operations
• Understand and follow appropriate SDLC, quality validation processes and application processes.
• Communicate status, solutions and concerns. Disseminate information in a timely manner within the team and across functions
• Provide cross-functional and business knowledge to develop business system and process alternatives.

Quality Lead

Confidential, Round Lake, IL

• Final-level review of system functional and design specification documents, test procedures and quality standards
• Final-level review of validation or performance qualification protocols for new or modified PLM and manufacturing processes or systems for pharmaceutical or other types of production.
• Develop validation master plans and standard operating procedures.
• Final-level review of the link between user requirements, functional and design specifications
• Direct software system testing and validation procedures, programming, and documentation.
• Guide project team members on skills required for the documentation of validation documents and qualification protocols required in an FDA compliant system for a Pharmaceutical industry
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Develop and manage work breakdown structure (WBS) of information technology projects.
• Monitor or track project milestones and deliverables.
• Submit project deliverables, ensuring adherence to quality standards.
• Monitor the performance of project team members, providing and documenting performance feedback.

Project Manager

Confidential

Responsibilities

• Develop and manage work breakdown structure (WBS) of information technology projects.
• Manage all project tasks to project schedule and ensure that schedule is updated. Use schedule to anticipate issues that may impact project delivery.
• Monitor or track project milestones and deliverables.
• Submit project deliverables, ensuring adherence to quality standards.
• Monitor the performance of project team members, providing and documenting performance feedback.
• System requirements elicitation with business SMEs
• Requirement prioritization in consultation with system owner
• Consult with SMEs about software system design and maintenance and gather requirements
• Expand or modify system to serve new purposes or improve work flow.
• Direct the development of system functional and design specification documents
• Direct the development of application User Manual for system end-users
• Final-level review of validation or performance qualification protocols for new or modified PLM and manufacturing processes or systems for pharmaceutical or other types of production.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Populate or maintain databases for tracking validation activities, test results, or validated systems.

Business/Systems Analyst

Confidential

Responsibilities

• System requirements elicitation with business SMEs
• Requirement prioritization in consultation with system owner
• Consult with SMEs about software system design and maintenance, gather requirements and define solutions
• Expand or modify system to serve new purposes or improve work flow (upgrade of Teamcenter from Unified 2007 to Unified 9.1.2.2)
• Develop, document and maintain system functional and design specification documents
• Final-level review of validation or performance qualification protocols for new or modified PLM and manufacturing processes or systems for pharmaceutical or other types of production.
• Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
• Develop and maintain link between user requirements, functional and design specifications, and created validation qualification protocols for systems implemented for Pharmaceutical industries
• Develop and direct software system testing and validation procedures, programming, and documentation.
• Populate or maintain databases for tracking validation activities, test results, or validated systems

Software Developer

Confidential

Responsibilities

• Analyze user needs and software requirements to determine feasibility of design within time and cost constraints.
• Modify existing software to implement new functionality and correct errors, as per customer requirements
• Confer with systems analysts, engineers, programmers and others to design system and to obtain information on project limitations and capabilities, performance requirements and interfaces.
• Develop and direct software system testing and validation procedures, programming, and documentation.
• Creation of user and admin manuals for the application software to help users and application administrators in usage of system

Systems Analyst

Confidential, Warsaw, IN

Responsibilities

• Confer with clients regarding the nature of the information processing or computation needs a computer program is to address.
• Develop, document and revise functional specifications, system design procedures, test procedures, and quality standards.
• Consult with management to ensure agreement on system principles.
• Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• Develop user manuals, training materials and procedures, and train users in the proper use of software.
• Provide staff and users with assistance solving computer related problems, such as malfunctions and program problems.
• Train staff and users to work with computer systems and programs.