SUMMARY:

Highly skilled and experienced, self - motivated consultant, project/department manager, systems and software engineer. Experienced in corporate systems implementation, validation, regulatory compliance, department and business development and problem solving. Thrives in a challenging project environment.

TECHNICAL SKILLS:

• 21 CFR Part 11, 58, 210, 211, 820,
• EU Annex 11
• HIPAA
• Requirements Definition
• Agile/SCRUM Development Methodology
• Budgets/Estimates
• System Development Lifecycle (SDLC)
• Master/Project Planning
• Software Quality Assurance (SQA)
• Computerized Systems Validation (CSV)
• Standard Operating Procedures (SOP)
• Infrastructure Qualification
• Technical White Papers (TWP)
• Gap Analysis and Remediation
• Test Plans/Scripts
• General Principles of Software Validation
• Proposals
• GMP, GLP, GCP
• Risk Assessments
• Project Management
• System and Network Design and Implementation
• Remediation/CAPA Planning
• Technical Assessments
• Disaster Recovery Planning
• Compliance Assessments
• Validation Plans
• Return on Investment (ROI) Analysis
• Regulated Industries
• Automated Software Testing
• Timelines\WBS
• IQ/OQ/PQ
• Empower
• Building Management Systems
• Werum PAS-X MES
• Laboratory Notebooks
• LabWare LIMS
• LabVantage LIMS
• Scientific Data Management Systems (SDMS)
• Trackwise
• LAL Systems
• Documentum
• Biovia Accelrys LIMS / Discoverant
• Microsoft SQL Server
• SAP
• Dell workstations/laptops
• PeopleSoft
• Microsoft Exchange
• Confidential eCTD Systems
• Microsoft SharePoint
• Laboratory Systems (FT-IR, Spectrometers, Microplate readers, chromatography, etc.)
• QAD
• Network Infrastructure
• Confidential Confidential
• Process Control System (PCS)
• Outlook
• Fermentation Control Systems
• Oracle
• Empower
• Microsoft Office

PROFESSIONAL EXPERIENCE:

Systems Architect

Confidential, Santa Clara, CA

Responsibilities:

• Delivered Computer Software Validation services to Life Science Industry customers as a consultant.
• Drafted and managed the approval process for all SDLC documents required for FDA compliance.
• Organized, planned and managed all aspects of the validation projects.
• Developed project validation project resource requirements models for project planning.

Sr. LIMS Analyst

Confidential, Carlsbad, CA

Responsibilities:

• Administered a highly customized LabVantage LIMS used for genetic testing on human tissue samples from patients enrolled into oncology clinical trials for several leading pharmaceutical companies.
• Lead software development activities for system enhancements following company Change Control and SDLC procedures.
• Gathered user and functional requirements and authored system design documentation.
• Authored, executed and peer reviewed IQ and OQ test protocols.

Quality Assurance Manager

Confidential, Irvine, CA

Responsibilities:

• Managed QA activities for a SaaS portal that provides online GCP solutions for clinical trial protocol development, training and clinical trial data management.
• Developed SOPs and business processes for the company. Responsible for managing activities including System Development Lifecycle, Change Control, Problem Resolution and Deviation Management.
• Defended the company during vendor audits, reduced audit findings by 50%, authored audit responses and closed corrective action activities.

Quality Assurance Manager

Confidential, San Diego, CA

Responsibilities:

• Managed the QA department for a SaaS system that provides online training for practitioners involved in clinical trials.
• Developed SOPs and business processes for the company.
• Managed validation projects and change control approvals.
• Wrote project plans, IQ, OQ and PQ test scripts, and summary reports.
• Participated in system architecture development and audited existing validation projects and business processes.
• Defended the company during vendor audits, reduced audit findings by 80%, authored audit report responses and closed corrective action activities.

Sr. Software Validation Engineer

Confidential, San Diego, CA

Responsibilities:

• Lead the Computer System Validation activities for QAD enterprise resource programs, building management systems and infrastructure development projects.
• Implemented the change control process for IT application and infrastructure maintenance.
• Developed all aspects of the validation V-Model including SOPs, Risk Assessments, User Requirements Specifications, Design Specifications, Validation Plans, IQ/OQ/PQ Protocols, Requirements Traceability Matrices and Summary Reports.
• Lead working meetings as required to collect the information necessary for those documents.

Quality Assurance Engineer

Confidential, San Diego, CA

Responsibilities:

• Lead the Computer System Validation activities for SAP and PeopleSoft based enterprise application and infrastructure development projects.
• These projects included electronic device history records, cycle counts, installation logs, document management and IT infrastructure.
• Trained and coached end users to develop requirements and test script documents.
• Authored business and regulatory risk assessments, validation protocols and summary reports.
• Developed a project model for estimating project levels of effort.

Computer Validation Consultant / Project Manager

Confidential, San Diego, CA

Responsibilities:

• Provided consultation services from 1 month to 1 year for the following clients:

Validation Consultant

Confidential, Irvine, CA

Responsibilities:

• Assessed the client’s CSV direction to author SOPs and corporate standards.
• Performed user requirements analysis to author requirements and design documents for pharmaceutical manufacturing and laboratory systems.
• Authored test protocols and approved completed protocols.
• Authored validation summary reports.

Validation Consultant

Confidential, Mountain View, CA

Responsibilities:

• Validation of the Confidential module of a LabWare LIMS system.
• Authored test scripts.
• Performed dry-run and final execution of test scripts.

Validation Consultant

Confidential, Carson, CA

Responsibilities:

• Performed the validation remediation of a Werum PAS-X MES system.
• Analyzed existing validation for GMP compliance.
• Wrote the Gap Analysis Report and presented findings to C-level management.
• Developed and wrote the remediation plan to close compliance gaps.
• Managed execution of validation activities through project completion.

Validation Consultant

Confidential, Irvine, CA

Responsibilities:

• Performed a Computer Systems Validation assessment for 50 systems. Wrote regulatory impact and risk criticality assessments, validation assessments, 21 CFR Part 11 assessments and SOP assessments.
• Performed gap analysis and prioritized systems for remediation.
• The systems were pharmaceutical laboratory instrument control, manufacturing process control and environmental monitoring applications and related SOPs.
• The project required working with scientists, engineers, managers in many departments across eight divisions of the company.
• Specific systems include: Kaye, Empower, Calibration Manager, LIMS, Chemstation and CoreDossier.

Project Manager

Confidential, San Diego, CA

Responsibilities:

• Lead a network validation project for a company with 600 employees.
• The project required writing a risk-based assessment, gap analysis, qualification plans, test protocol documents, configuration management documentation, test scripts, summary reports and standard operating procedures.
• The network consists of more than 100 servers and several hundred workstations.

Validation Consultant

Confidential, South San Francisco, CA

Responsibilities:

• Wrote the Qualification plan, Network Design Specifications and Qualification Protocol for an IT Network Infrastructure qualification project.
• Supported protocol execution and summary report generation.
• The network supports clinical trials for four pharmaceutical products.

Project Manager

Confidential, San Diego, CA

Responsibilities:

• Lead a highly urgent network qualification project in preparation for an FDA audit.
• The project required qualification plans, test protocol documents, configuration management documentation, test scripts, gap risk analysis and summary reports for a 500 node network be delivered and approved in three weeks.
• The network supports a GMP manufacturing facility for two pharmaceutical products. The project required the supervision of 5 of the client’s staff and was completed on time and under budget.

Sr. MIS Manager

Confidential, San Diego, CA

Responsibilities:

• Re-engineered the technical architecture for a Pharmaceutical Development Laboratory with 150 users under FDA IT regulations. Developed the IT business strategy, wrote the master plan, budget and schedule. Present them to senior management and obtained approval. Projects included replacing the plant cabling, switching, routing, server, operating system, and telephone architectures. Managed the IT Change Control procedure using Trackwise.
• Engineered the technical architecture for a newly acquired Pharmaceutical Manufacturing facility to support 100 users under FDA IT regulations. Developed the IT business strategy, wrote the master plan, budget and schedule for the build out. This project required supervising 1 employee and 2 contractors.
• Managed computer software validation projects for cGxP systems. These projects required building the project team, reviewing and approving validation plans, test protocols, configuration management documentation, test scripts and summary report.
• Managed the implementation of corporate applications including PeopleSoft, Confidential, Documentum and Trackwise. Compared business processes against application processes and wrote business cases for changes to the applications and business processes.