PROFESSIONAL SUMMARY:

• Knowledgeable and sharp Project/Program Manager and IT Manager with extensive experience managing technical staff and teams within the Software, Infrastructure, Server, Network, Virtualization and Help Desk areas.
• Proven record of success leading all phases of diverse technology projects.
• Business strategist, planned and managed several projects aligning business goals with technology solutions.
• Manage project risks, track records of expenditure, costs, budgets, resource allocation, and technical teams up to eight (20) people while participating in all phases of the Project Life Cycle.
• Excellent communicator, able to leverage technical, business and financial acumen to communicate effectively with Stakeholders and teams.
• Expert in Waterfall and V Project Management methodologies and Agile Methodology.
• Able to interact with management and clientele in English and Spanish.

TECHNICAL SKILLS:

Project Management: Compliance with policies and procedures, Initiate, Develop, Control, Execute, Deliver, Maintain, Lessons Learned, Stakeholder Management, Cost Management, Risk Management, Quality Management, Communication Management, Resource Management, Corporate strategies

IT Project Lifecycle: Initiation, Planning, Requirements Analysis, Design Analysis, Traceability Matrix Cost and budgeting, Scheduling, Testing and deployment, Maintenance and support, Decommissioning

Value added leadership: Cross - Functional Team Management, Virtual Teams, Team building and mentoring, Stakeholders Management, Business and IT Planning, Vendor Management, Phase gate reviews

Tools: and Applications: MS-Office, MS Project, MS VISIO, Crystal Reports, ORACLE D Confidential Modeling, SCADA, ERP Systems (SAP R/3), DMS Systems (Documentum), MES, PLM Systems (TeamCenter)

Regulations: 21 CFR part 11, Part 820; EU CSV Annex 11, ISO 9001

WORK EXPERIENCE:

Confidential, Aguadilla, PR

Sr. Project Manager

Responsibilities:

• Coordinated multiple IT software and IT hardware (discretionary and contractual) capital projects within a large scale program, activities of associated project teams; tracks progress against established plans, reports results, and makes recommendations for alterations and/or updates to team manager.
• Reviewed, approved and submitted Capital Appropriation requests.
• Planned, managed scope, schedule, budget, testing, task assignment and resources with other cross-functional teams to ensure adherence to the agreed SOW.
• Reviewed cost-benefit analyses, NPV and ROI assessments that were used as the basis for decision-making on proposed projects. Used planning tools to generate/create, manage and track project quality and results.
• Designed, built and directed the work of project teams. Managed performance of team members, set expectations and motivated my team. Participated in the selection process of resources.
• Business focal point with my organization (engineering) with Corporate to understand corporate strategies and work with them to establish new solutions, always ensuring objectives aligned with their strategy.
• Successfully managed software and hardware capital portfolio with an annual budget of $8 to $10 Million.
• Successfully led and coordinated project teams of up to 20 members globally distributed which led to completing 95% of my projects on-time and under budget.
• Reviewed Monthly financial results and provided analysis for divisional budgets and forecasts to management.

Sr. IT Project Lead/Sr. Business Analyst

Confidential

Responsibilities:

• Helped assess performance, lead the development of improvement plans and was part of the team to multidisciplinary team to implement solutions ensuring continuous improvement of capabilities enterprise wide.
• Collaborated with Senior Management to identify risks and opportunities for the delivery of infrastructure and services through technology and innovation.
• Planned, managed scope, schedule, budget, testing, task assignment and resources with other cross-functional teams to ensure adherence to the agreed SOW.
• Responsible for establishing and enforcing IT metrics and goals to effectively communicate performance, productivity and goal completion.
• Led and managed multi-function resources across multiple large scale projects driving the development and implementation processes for the deployment of infrastructure for major engineering applications.
• Reviewed cost-benefit analysis to identify potential risks and opportunities
• Managed activities, resource capability, schedule, and budget to ensure cross company communications to facilitate product completion on schedule and within budget.
• Monitored and validated the enterprise’s compliance with its security policies, which includes but is not limited to Sarbanes Oxley Section (SOX).
• Helped support global teams in transforming business processes including QA and IT.

Confidential, San Germán, PR

Sr. SQC Engineer

Responsibilities:

• Developed and used business processes and strategies to provide analysis to management in identifying potential issues, areas of improvements and recommend actions.
• Provided CSV oversight for all computer validation projects ensuring that deliverables are completed following local, state and federal guidelines.
• Developed, updated and sustained CSV global processes.
• Managed activities, resource capability, schedule, and budget to ensure cross company communications to facilitate product completion on schedule and within budget for ERP Systems (SAP) implementation including Stakeholder, Change, Resources, Budget and Time Management. Modules deployed included Operations (Material Management, Production Planning and Quality Management), Financials (Supply Chain Management), HR () and Resource management.
• Supported the team in the execution of system audits and actively provided answers to member for clarifications in processes and technical matters.
• Became the subject matter expert and provided guidance on SDLC, cGMP regulations, standards and quality management systems (FDA CFR Regulations, ISO regulations).
• Led and managed multi-function resources across multiple large scale projects driving the development and implementation processes for the validation of infrastructure and applications (MES, Labs, IT).
• Hired, trained and managed third party resources/consultant in the on-time implementation/re-qualification of key applications/equipment.
• Successfully improved the CSV Methodology into a Lean Methodology, which provided a 10-20% reduction in deliverables and a 15-25% reduction in deliverables review and approval.
• Supported CAPAs and non-conformances..
• Applied project and program methodology, resource allocation plans, budgets, and requirements.
• Accountable for assuring that the business adhere to the IT System Development Methodology (SDM) for all IT implementations of new applications and infrastructure.

Confidential, Carolina, PR

CSQ Representative (Project Manager)

Responsibilities:

• Oversaw and provided QA support during the implementation, validation and changes for SAP/R3 and existing laboratory (LIMS) and manufacturing (MES) validated systems using Project Management tools and techniques. Ensured that metrics and key performance indicators aligned with corporate quality strategies.
• Managed and provided quality and compliance oversight on teams (input, review and approval) for the implementation, validation and maintenance of computerized (IT) systems (including SAP, LIMS) in accordance to established local, state and federal regulations (Part 11, GxP).
• Oversaw the Change Management process and quality of delivery of all SAP implementation related documentation.
• Managed activities, resource capability, schedule, and budget to ensure cross company communications to facilitate product completion on schedule and within budget for ERP Systems (SAP) implementation including Stakeholder, Change, Resources, Budget and Time Management. Modules deployed included Operations (Material Management, Production Planning and Quality Management), Financials (Supply Chain Management), and HR ( and Resource management) .
• Monitored and audited business units to ensure compliance with established processes and guidelines (FDA, GAMP, CFR, etc.)
• Part of a team that helped prepare and execute the ERP Global Technology Roadmap for the deployment of SAP R/3, while becoming the single point of contact in Quality matters for this deployment.
• Helped align IT Risk Management with enterprise-wide risk management.
• Worked with IT and Corporate stakeholders to assess performance of SAP R/3, led a team for the development of improvement plans and helped implement the solution ensuring compliance with corporate standards and needs.
• Planned, developed, reviewed and executed a program for annual exercises of low cost Disaster Recovery and Business Continuity Plans for laboratory and manufacturing processes to mitigate c Confidential strophic risks for the site’s infrastructure and applications.

Confidential, Hato Rey, PR

Computer System Validation Manager

Responsibilities:

• Successfully led validation projects of up to $1 Million completing 98% on-time and on-budget.
• Planned, Developed and Implemented validation projects in several pharmaceuticals in support of Risk Based Validation Programs like 21 CFR Part 11, Manufacturing Equipment, Laboratory and Computerized Equipment including the generation of Validation Plans, Requirements and Design specifications, IQ, OQ, PQ, etc. using Project Management tools and techniques.
• Reviewed cost-benefit analyses and ROI assessments that were used as the basis for decision-making on proposed projects
• Successfully managed internal resources in local and remote locations.

Confidential, Vega Baja, PR

Computer System Validation Manager

Responsibilities:

• Became the business facing role within the IT organization whose role was to understand business strategies to be able to provide solutions using new and current legacy ERP and new ERP (SAP R/3).
• Managed activities, resource capability, schedule, and budget to ensure cross company communications to facilitate product completion on schedule and within budget for ERP Systems (SAP) implementation including Stakeholder, Change, Resources, Budget and Time Management. Modules deployed included Operations (Material Management, Production Planning and Quality Management), Financials (Supply Chain Management), HR ( and Resource management .
• Helped align IT Risk Management with enterprise-wide risk management including SAP R/3 change priorities and resource workload in supporting requests.
• Developed and executed a comprehensive DR strategy/plan for the recovery of critical IT services (applications & infrastructure) in readiness for the possibility of a disaster. Coordinated annual exercises.
• Helped leverage technical expertise to help the development of the plan, execution, troubleshooting and resolution of user and technical issues.

Confidential, Dayton, OH and San Antonio, TX

Electronics Engineer/Computer Systems Scientist Manager

Responsibilities:

• Managed internal audits and risk assessment in support of computerized systems security and compliance with security policies and procedures.
• Assessed and suggested corrective actions and preventive actions on the findings.
• Created, deployed and maintained a concise Disaster Recovery and Vulnerability program to secure d Confidential in accordance to policies and procedures.
• Led a Project to create a flight simulator (Man-in-the-loop System Performance Evaluation Model) Using C++ and FORTRAN on which all related cockpit devices, systems and displays were available to a real AF pilot.
• Supported all activities related to software development life-cycle from Planning to Deployment and maintenance (SDLC) following Project Management Methodologies.
• Led a team on the planning, design, build and commissioning of a secured D Confidential Center.
• Formed a Help Desk operation, hired, trained and Managed all operations and employees of Help Desk area, including end user support, while implementing/establishing statistics, metrics and KPIs to improve response times of the Help Desk. Formulated and implemented Help Desk and IT infrastructure area metrics, stats, and Key Performance Indicators (KPIs) for all my direct reports while managing all shifts 24/7.