SUMMARY

• Knowledgeable and sharp CSV, Engineer and IT Manager with extensive experience leading validation activities within a GxP Manufacturing environment.
• 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 SDLC.
• Excellent communicator, able to leverage technical, business and financial acumen to communicate effectively with Stakeholders and teams.
• Expert in ensuring Compliance of Computerized systems with applicable regulations.
• 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

Regulations: 21 CFR part 11, Part 820; EU CSV Annex 11, ISO 9001, GAMP5

PROFESSIONAL EXPERIENCE

Confidential

Validation and Project/Program Management Consultant

Responsibilities:

• Responsible for developing and implementing validation strategies and documentation for various systems, including Manufacturing, Process, Packaging and Laboratory.
• Ensure that all systems and facilities comply with regulatory, quality and compliance policies.
• Provide leadership in the definition of requirement definition, quality assurance, risk mitigation and contingency planning following Project Development Lifecycle techniques.
• Provide project management technical guidance and oversight during the validation of CSV equipment.
• Author and execute validation documentation (i.e., Validation Plan, Requirements, IQ/OQ/PQ, etc.)
• Provide expertise in Risk Assessments and Technical Issues encountered during the validation execution.
• Interact with regulatory agencies during inspections to answer questions related to CSV and Process Validations (i.e., SDLC, etc.)
• Consult on low cost Disaster Recovery and Business Continuity Plans for laboratory and manufacturing processes to mitigate catastrophic risks for the site’s infrastructure and applications.

Confidential

Sr. Project Manager CPMO

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.
• Ensured adherence to all relevant regulatory and compliance requirements (SOX) in support of the Engineering organization.
• 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.
• Led the development of requirements, risk assessment, test plans, design, IQ/OQ/PQ tests and commissioning documentation.
• Helped staff accomplish results by communicating job expectations, planning their work, monitoring performance (job results), coaching and counseling, coordinating and enforcing policies, procedures and standards.
• 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.
• Communicated proactively with stakeholders and managed progress, issues and actions for resolutions.

Sr. IT Project Lead/Sr. Business Analyst

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

Sr. SQC Engineer

Responsibilities:

• 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 catastrophic risks for the site’s infrastructure and applications.
• 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.
• Developed and/or led the generation CSV documentation following corporate policies and procedures including Validation Plan, Requirements and Design (URS, RTM), Test plans and commissioning.
• Represented and supported the team in the execution of system audits and actively provided answers to member for clarifications in processes and technical matters.
• Led Risk Assessments and worked with internal customers to identify and implement improvements related to the SDLC which led to successfully improve the CSV Methodology (SDLC) into a Lean Methodology, which provided a 10-20% reduction in deliverables and a 15-25% reduction in deliverables review and approval.
• Led and managed multi-function resources across multiple large-scale projects driving the development and implementation of CSV processes for the validation of infrastructure and applications (MES, Labs, IT).
• Supported CAPAs and non-conformances.
• Applied project and program methodology, resource allocation plans, budgets, and requirements.
• Accountable for assuring that the business adheres to the IT System Development Methodology (SDM) for all IT implementations of new applications and infrastructure.