SUMMARY:

• Senior Validation Engineer with over 15+ years experience in the regulated pharmaceutical, Biotech and Medical Device industries.
• Extensive and progressive experience in Validation, quality and compliance in Confidential regulated manufacturing facilities.
• Possesses outstanding organizational and communication skills.
• Proven ability to perform individually or as a member of multi - disciplinary groups and cultures.
• Acted as Project Lead for all phases of SDLC related activities with deep knowledge of cGMP and Confidential techniques, including 21 CFR Part 11.
• Performed technical writing activities for Process Operational Manuals, SOPs and various other publications.
• Extensive experience in Aseptic and Sterile manufacturing environments, manufacturing and Medical Devices.

PROFESSIONAL EXPERIENCE:

Confidential, San Francisco, CA

Senior Validation Engineer

Responsibilities:

• Provide Regulatory Compliance / Quality Assurance to ensure Illumina’s computer system validation deliverables software and processes for Medical Devices are thorough, complete and developed in a manner consistent with Illumina’s and in a manner acceptable to various health authorities.
• Review and approve documents for computer system and process validation and Change Control projects related to Drug Safety Electronic Computer systems for Medical Devices
• Provide Regulatory Compliance / Quality Assurance to ensure Gilead’s computer system validation deliverables are thorough, complete and developed in a manner consistent with Gilead’s SOP’s and in a manner acceptable to various health authorities.
• Review and approve documents for computer system validation and change control projects related to Drug Safety Electronic Computer systems.
• Responsible for Review and Approval of all CSV documentation related to ARISg Suite and associated systems validation documentation for Gilead Global,
• Responsible for review/Approval of all Change Control activities related to ARISg Suite for Roche Global,including ARISg Suite upgrade to v6.6 and Oracle 10 upgrade to Oracle11.0, and Confidential management.

Confidential, San Francisco, CA

Senior Validation Engineer

Responsibilities:

• Project lead for evaluation, installation, validation and implementation of Confidential system, Electronic Lab Notebook (ELN), and upgrades of ARISg and Livelink.
• Responsible for Change Control process for various projects.
• Authored relevant SDLC documents for validation of system (Validation Plan, Requirements documents, IQ, OQ, PQ, UAT scripts and review and approval of same).
• Resolved testing deviations, responsible for Confidential, performed Risk and Gap analysis.
• Reviewed and performed Gap analysis of all IT department SOPs for compliance with Part 11 and Annex 11, and updated existing or authored new SOPs as necessary.
• Project lead for evaluation, installation, validation and implementation of various enterprise programs.
• Responsible for Change Control process for various projects.
• Authored relevant SDLC documents for validation of system (Validation Plan, Requirements documents, IQ, OQ, PQ, UAT scripts and review and approval of same).
• Installed, implemented and validated HP ALM (Quality Center and the e-sig module.
• Resolved testing deviations, responsible for Confidential, performed Risk and Gap analysis.
• Followed Confidential 820, Part 11 requirements.
• Worked with Documentum, SharePoint and Adobe document systems.

Confidential, Birmingham, Al

Senior Validation Consultant

Responsibilities:

• Develop Quality Testing program for Validation & Certification of Clinical Laboratory methods and Instruments to meet CSLI and Confidential regulations
• Install and validate Statistical software (COTS) to employ in Quality program
• Authored various Project Plans, Validation Protocols, test cases and reports for qualification and validation
• Very capable with Documentum and SharePoint.

Confidential

Sr. Business Analyst / Validation Engineer

Responsibilities:

• Evaluated customer modified Oracle Business Service Module for impact of new modules and validation requirements to meet 21 CFR Part 11.
• Authored Test Plan and test scripts for validation execution, dispositioned executed scripts, performed Risk Analysis, Compiled Trace Matrix and authored Testing Summary Report.

Confidential, Cambridge, MA

Sr. Test and Transition Lead

Responsibilities:

• Lead in planning, implementation and validation of Global Learning Management System, including data migration from multiple sources into new LMS.
• Lead in creating Function and Business Requirements
• Supervised technical writing group in preparation of SDLC deliverable documentation, including Validation Plan, testing scripts and relevant SOPs and Work Instructions.
• Lead in Testing and Validation for consolidation of company multiple data centers into a global central data center, including validation of off-site Disaster Recovery facility.
• Resolved testing deviations, responsible for Confidential, performed Risk and Gap analysis.
• Followed c 820, Part 11 and applicable Confidential requirements (9001 + 13485, 14971, 62304.)
• Validated upgrade for Documentum and also used SharePoint and Adobe.

Confidential

Sr. business Analyst

Responsibilities:

• Lead in upgrade and validation of LiveLink (Open Text) from v5.1 to v9.3
• Lead in installation and validation of ARISg from v5.3 to v 6.1.
• Responsible for all SDLC related documentation for IQ, OQ, PQ and UAT including authoring or reviewing scripts, data migration plans and facilitating final execution and authoring Validation Reports.
• Resolved testing deviations, responsible for Confidential, performed Risk and Gap analysis.
• Followed Confidential 820, Part 11 and applicable Confidential requirements (9001, 14971 and 13485).

Confidential, San Diego, CA

Sr. Validation Engineer

Responsibilities:

• Participated in evaluation and selection of Drug Safety Program and provided recommendation.
• Gathered configuration requirements involving workflows, data distribution and Study reports.
• Authored Functional and Business requirements documents and assisted IT with Design specifications.
• Team leader in installation of ARISg including authoring Validation Plan, all testing scripts, Risk Assessment and Gap Analysis.
• Authored all Summary reports, TM and Final validation reports.
• Responsible for creating and setting up Change Control system for company use.
• Resolved testing deviations, responsible for Confidential, performed Risk and Gap analysis.
• Followed Confidential 820, Part 11 and Confidential (9001, 14971 and 13485) requirements.
• Authored SOPs and Work Instructions necessary for ARISg to meet regulatory requirements.
• Authored and facilitated ARISg training for Drug Safety department members.
• Introduced company’s first paperless process for review and approval of all documents using Documentum and SharePoint for document management and e-signature.

Confidential, Corona, CA

Sr. Technical Writer/Validation Engineer

Responsibilities:

• Participated in evaluation and selection of Drug Safety Program and provided recommendation.
• Gathered configuration requirements involving workflows, data distribution and Study reports.
• Authored Functional and Business requirements documents and assisted IT with Design specifications
• Lead in validation of Labware LIMS system to in corporate into company regulated computer system.
• Lead in implementation and validation of major enterprise system software/hardware upgrades including TrackWise and LiveLink. Authored SOPs, training manuals and Work Instructions.
• Lead in validation of various network and infrastructure systems and software.
• Resolved testing deviations, responsible for Confidential, performed Risk and Gap analysis.
• Followed Confidential 820, Part 11 and Confidential (9001 and 14971) requirements.
• Managed vendor audit program, and Change Control system.
• Provided technical assistance and was Lead in company transition from manual in-house document system to newly created EDMS system.
• Authored Project plans, validation plans and supervised entire validation process (SDLC) including review of all documents, writing summary and final validation reports.

Confidential, Sylmar, CA

Sr. Consultant Engineer

Responsibilities:

• Created and implemented policies and procedures, and training program (Quality System) for Medical Device manufacturer to comply with Confidential MDR program.
• Advised on responding to MDR complaints
• Followed Confidential 820, Part 11 and Confidential requirements.

Confidential, Thousand Oaks, CA

Sr. Technical Writer

Responsibilities:

• Authored and published SOPs, Validation templates and procedures for Regulated Information Systems Quality department for GMP/GLP/GCP global unity. Facilitated efforts of 5 off-site divisions to bring documents into global unity.
• Authored SOPs for validation of COTS and CRS systems including Confidential Part 11 requirements. Created and implemented document management and storage system.
• Created templates for all phases of validation effort for Regulated IS department, including Validation Plan, Requirement/Design Specification, IQ/OQ/PQ, as well as summary reports and testing procedures.
• Established SDLC and Change Control procedures.
• Co-authored Disaster Recovery policies and procedures for corporate IT department.
• Conducted Risk Management evaluation of procedures for Quality department.

Confidential, Wallingford, CT

Sr. Technical Writer

Responsibilities:

• Authored over 200 SOPs and OIs for BioSafety Level-3 facility to ensure proper cGLP. Authored Lockout/Tag out documents for all equipment and systems at facility. Created and implemented manual database (MS Access) for storage and retrieval and searching of company’s procedures.
• Developed and implemented Change Control procedures for division. .

Confidential, Kalamazoo, MI

Sr. Technical Writer

Responsibilities:

• Manager and Lead Technical Writer for Pharmaceutical Technical Services (PTS) Group. Provided technical writing and validations to meet company’s quality validation requirements.
• Authored various validation protocols, product specifications, SOPs, engineering studies. Authored Line Trial and Validation Protocols for sterile and non-sterile validations analyzed data and authored final reports. Facilitated multi-discipline validation teams.
• Developed hierarchy and served as Administer for Documentum. Conducted department training for Documentum.

Confidential, Everett, WA

Technical Writer

Responsibilities:

• Provided consulting and technical writing to meet company’s requirements for cGLP and Confidential certification and Confidential Part 11 compliance.
• Designed and initiated implementation of a complete Confidential and cGLP compliant documentation system for clinical testing laboratory including implementation of manual document storage and retrieval database. Designed SOP formats and supervised writing of documents.

Confidential, Spokane, WA

Technical Writer

Responsibilities:

• Originated style guide for Technical Writing group. Authored in excess of 100 Process Operation Manuals used for operator training and certification. Authored SOPs and other publications as required. Designed template and authored Confidential documentation for more than 400 pieces of equipment and power sources. Wrote manuals for use in Europe, Asia, Africa and USA.
• Authored and facilitated companywide Six Sigma training program and other training programs