Engineer Management
Resume:
Eligio A. Cardona
Mayagüez, PR 00680
******.*******@*****.***
Cell.: 787-***-****
QUALIFICATION HIGHLIGHTS
Cost/Budget Management
GAMP 5
Source Code Review
Quality Assurance / Compliance
Team Leadership
IT Management
Regulated Industry (FDA, SOX)
Computer Systems Validation
CSV/Validation SME
System Development Lifecycle
Strategic Planning
Risk Management
Green Belt Certified
IT Infrastructure
Change Control Management
SAP Implementation
PMP Certification in progress
Fully Bilingual
Successful in the management of complex validation projects and authoring and/or reviewing validation documents.
Thoroughly understand industry standards and best practices computer system validation such as GAMP 5 and data integrity requirements.
Comprehensive knowledge of Validation lifecycles for Computerized Systems and Process Control Systems and aseptic processing, sterilization validation, Cleaning validation and equipment and utility validation.
PROFESSIONAL EXPERIENCE
Honeywell Aerospace, Aguadilla, PR 2007 – 2017
Sr. Project Manager – Engineering Testing Services, Capital Program Management Office
2014 - 2017
Coordinate multiple software and hardware (discretionary and contractual) projects within a large scale program. Coordinate the activities of associated project teams; tracks progress against established plans, reports results, and makes recommendations for alterations and/or updates to team manager. Review, approve and submit Capital Appropriation requests. Plan, manage scope, schedule, budget and resources with other cross-functional teams to ensure adherence to the agreed SOW. Manage risk, opportunities, change and communication Provide input on project planning, budgeting, scheduling, tracking and reporting of associated capital discretionary projects.
Selected Accomplishments
Successfully manage software and hardware capital portfolio with an annual budget of $8 to $10 Million.
Successfully led and coordinated project teams of up to 10 members globally distributed which led to completing 95% of my projects on-time and under budget.
Ensured that SDLC best practices were identified and followed.
Sr. IT Project Leader (Manager)/ Sr. Business Systems Analyst – Engineering Infrastructure
2007-2014
Led infrastructure, operations, and communications team efforts for the deployment of IT infrastructure for Aerospace Programs. Developed strategic plans and best practices and principles for Validation activities. Collaborated with Senior Management to identify risks and opportunities for the delivery of infrastructure and services through technology and innovation. Responsible for the adherence of Business Continuity and Disaster Recovery plans for IT infrastructure. Responsible for establishing and enforcing IT metrics and goals to effectively communicate performance, productivity and goal completion.
Selected Accomplishments
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.
Ensured that all best practices for SDLC were followed on all validation documentation and executions.
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).
Used planning tools to generate/create, manage and track project results.
Cordis, LLC (Johnson & Johnson), San Germán, PR 2006 – 2007
Senior SQC Engineer
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. Monitored progress of projects so goals and objectives were met on time and within schedule. Supported the team in the execution of system audits and actively provided answers to member for clarifications in processes and technical matters. As subject matter expert, provided guidance on cGMP regulations, standards and quality management systems (FDA CFR Regulations, ISO regulations). Became the subject matter expert on computerized systems SDLC. Managed and audited Source Code Reviews.
Selected Accomplishments
Led and managed multi-function resources across multiple large scale projects driving the development and implementation processes for the qualification and 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.
Prepared metrics for Monthly program reviews, as well as participating in management reviews.
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.
Lilly del Caribe, Inc., Carolina, PR. 2003 – 2006
CSQ Representative
Oversaw and provided QA support during the implementation, validation and changes for SAP/R3 and existing laboratory (LIMS) and manufacturing (MES) validated systems. Provided quality and compliance oversight (input, review and approval) for the implementation, validation and maintenance of computerized (IT) systems in accordance to established local, state and federal regulations (Part 11, GxP). Lead periodic reviews to ensure compliance of computerized systems. Provided oversight and collaborated with site leaders and resources in facilitating planning and support during validation and qualification activities. Evaluated and mitigated risks associated with validation and qualification of computerized systems to facilitate planning and support of testing and commissioning activities. Monitored and audited business units to ensure compliance with established processes and guidelines (FDA, GAMP, CFR, etc.)
Selected Accomplishments
Single point of contact for all Site Laboratory and Manufacturing QA activities.
Provided compliance expertise for a successful, on-time implementation of SAP R/3 application in the Supply Chain, Human Resources and Finance areas of the company. Performed Source Code Review.
Successfully supported validation activities on multiple sites across the island. Directed decommissioning of computerized software and hardware during site closures.
Helped align IT Risk Management with enterprise-wide risk management.
Led a multi-disciplinary team that defined metrics based on overall business objectives.
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 catastrophic risks for the site’s infrastructure and applications.
Mintanciyan Consulting, Inc., Hato Rey, PR 2001 – 2003
Computer Validation Engineer/Manager
Provided guidance and support to validation projects on several clients. Managed resources at the client sites. Became the subject-matte expert in Computer Systems Validation (CSV) topics.
Selected Accomplishments
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.
Successfully managed internal resources in local and remote locations.
Pfizer, Inc., Vega Baja, PR 1998 – 2001
Computer Engineer / Consultant
Selected Accomplishments
Provided compliance expertise for a successful, on-time implementation of SAP R/3 application in the Supply Chain, Human Resources and Finance areas of the company. Performed Source Code Review using Over-the-shoulder process.
Formed part of a multi-disciplinary team to successfully review and improve local and corporate CSV and QA standards.
Helped align IT Risk Management with enterprise-wide risk management.
Developed and executed a comprehensive DR strategy/plan for the recovery of critical IT services (applications & infrastructure) in readiness of a disaster. Coordinated annual exercises.
USAF, Wright-Patterson AFB/Brooks AFB 1987 – 1998
Dayton, OH /San Antonio, TX
Electronics Engineer (GS-0855-12) / Computer Engineer (GS-0854-12)
Computer Scientist (GS-1550-12) / Computer Specialist (GS-0334-12)
INFOSEC Engineer (Consultant)
Created, updated and maintained procedures governing the System Security management and configuration. Managed internal audits and risk assessment in support of computerized systems security and compliance with security policies and procedures. Coordinated with chain of command and help identified related risks. Assessed and suggested corrective actions and preventive actions on the findings. Created, deployed and maintained a concise Disaster Recovery and Vulnerability program to secure data in accordance to policies and procedures.
Selected Accomplishments
Led the implementation 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).
Led a team of engineers in annual and semi-annual exercises to ensure that all security policies, procedures and standards were met and enforced based on MIL Standards for IT secured environments. This saved over $2M annually on consultation fees.
Led a team on the planning, design, build and commissioning of a secured Data Center.
Held a Secret Security Clearance with NTK
Formed a Help Desk operation, hired, trained and managed staff in the delivery of services and support.
EDUCATION
Bachelor of Science in Computer Engineering
University of Puerto Rico, Mayagüez, PR Campus
Successful completion of 40 hours course in Project Management aligned to the PMI’s Project Management Body of Knowledge (PMBOK) Best Practices Guide. This course serves to satisfy one of the requirements of the CAPM and PMP certifications from the PMI
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