SUMMARY STATEMENT

Experienced Project Manager and Engineer with a strong, diverse technical background. Demonstrated success in various quality-oriented positions within the Pharmaceutical, Medical Device, Internet Technology, Aerospace and Engineering fields. Quality driven with an uncompromising commitment to integrity and ethics. Flexible and supportive of change, have utilized Operational Excellence / Process Excellence / Six Sigma tools and methodologies to optimize and improve processes.

PROFESSIONAL EXPERIENCE

Confidential

Principal Engineer

• Responsible for support of production operations, implementing cost and process improvement projects and modifications to enhance performance of existing products Class I and Class II medical devices in accordance with site procedures, cGMP and regulatory standards / guidelines including FDA Quality System Regulation 21 CFR Part 820 and ISO 13485 Quality Standard . Establish and manage project deliverables and scheduling of system life cycle.
• Lead and manage validation projects for new equipment and systems. Write change requests, protocols, and reports supporting validation activities for new equipment, processes, major maintenance and corrective actions.
• Author and maintain Site Validation Master Plan, in conjunction with validation project schedules and status.
• Streamline operations through revision of manufacturing work instructions reduced hose lot rejects by 58 .
• Contributed to site integration to GEHC's Quality Management System in 2011. Perform impact assessments to production non-conformances use TrackWise tool to address non-conforming product or processes, complete investigations and CAPAs in response to audits and production rejects.
• Led successful validation for a new expandable hose extrusion line and the addition of a new co-extruder to convert an existing line to produce Dual Lumen hose. Projects resulted in a 25-50 increase in production capability for each hose type.
• Collaborate with QA, QC and Document Control groups in reporting of metrics and technical training efforts. Serve as department representative on Engineering Change Control Board and Document Change Control Board.
• Augmented site Environmental Health Safety program as owner of EHS Element Management of Change and Preventive Maintenance, improving score from 1.3 to 4.5 maximum score: 5.0 .

Confidential

Quality Investigator

• Reviewed backlogged investigations and collaborated with Apotex employees toward resolution and closure, resulting in a greater than 25 reduction in open records.
• Facilitated work and engaged with cognizant parties to ensured completion of change control activities and Corrective and Preventive Actions CAPAs in response to investigations.
• Ensured adherence to GMP practices, site operating and validation procedures for closure of investigations.
• Reviewed batch records and test/maintenance data to support investigations and root cause determination.

Confidential

Senior Project Manager

• Oversaw revised validation procedures in conjunction with a Lean Six Sigma / Process Improvement project that resulted in greater than 50 reduction in time/labor required to qualify critical laboratory instruments.
• Reduced supervisor's workload by providing daily progress tracking and status updates on multiple projects, reporting critical path issues, anticipating potential roadblocks and managing conflict resolution.
• Served as department representative for site Safety Committee, conducting safety audits, training, and awareness sessions. Compiled and reported safety training records for department, and trained teams on cGMP.

Confidential

• Authored, maintained Site Validation Master Plan VMP for the Biotech division supporting commercial products. Ensured validation projects adhered to regulatory requirements comprising FDA and European Guidelines, 21 CFR Code of Federal Regulations , current Good Manufacturing Practices cGMPs , corporate policies and site SOPs.
• Serving as Project Manager supporting Validation / Technical Services in capital projects and engineering initiatives for site's polysaccharide manufacturing unit, promoted to also supervise 3-4 Project Managers overseeing validation efforts in separate vaccine production areas, QC Laboratories and Clinical Research Development.
• In 2008, was nominated and assumed Regulatory Project Manager role for Wyeth's first ever electronic document submission package for European and US market approval of company's improved pneumococcal vaccine product, Prevnar 13. This represented the largest product filing in US history. Worked with authors, reviewers and approvers, including QA and Regulatory Affairs, at various sites to manage document lifecycles.
• Collaborated with cross-functional teams across 6 sites, communicated open items and issues to lead Project Manager to mitigate delays and streamline efforts to ensure adherence to an aggressive CMC filing schedule.
• Played lead role in the successful preparation, review and final approval of validation documents and reports from department, representing over 25 of completed deliverables for Pearl River site.
• Authored validation plan documents, providing support to manufacturing and QC laboratory departments on project planning matters. Compiled and maintained validation project schedules across production and test areas supporting marketed product, as well as Clinical Research Development R D .
• Reported on status of validation project completions and adherence to Site VMP schedules. Identified projects in jeopardy of missing targeted deliverables, developed and executed action plans to alleviate business and compliance risks.