Deborah Drew Email & Phone Number

Principle consultant providing validation engineering and project management contract services. Recognized as a leading expert on autoclave usage and the instructor of the PDA’s course on Technical Report No. 1 (2007) Revision, Validation of Moist Heat Sterilization Process: Cycle Design, Development, Qualification and Ongoing Control.• Full Spectrum Validation Support (IQ / OQ / PQ / Process Validation)• Small and large molecule formulation• Sterile and non-sterile product presentations• Shipping, Facilities and Utilities• Training and employee development activities

Boulogne Billancourt, Fr

This managerial position was responsible for overseeing the engineering and validation group for a manufacturing facility in a multi-tenant building. • Overall responsibility for management of energy, security, facilities & equipment including maintenance and calibration of facilities, utilities, and manufacturing equipment within a multi-tenant building.• Managed two department budgets and a staff of five• Managed capital projects• Managed the site validation program

North Chicago, Illinois, Us

This managerial position was responsible for overseeing an engineering group as well as a metrology group. The engineering group’s responsibilities covered all aspects of AbbVie Bioresearch Center’s Utilities, Facilities, and Equipment validation program. The metrology group’s responsibilities covered manufacturing as well as laboratory equipment. General responsibilities included:• Managed 17 – 21 personnel that included engineers from entry to principle level, documentation specialist, a salaried calibration coordinator and non-exempt Technicians, as well as contract resources.• Managed Department Budget of over $1.5 million, including project proposals, capital expenditure requests, temporary/permanent headcount requirements, and long range planning to respond to demand and anticipated regulatory requirement changes.• Performed Resource planning, recruiting, and performance management to support organizational objectives along with employee development.• Developed department policies to comply with internal policies and external regulatory requirements. • Presented information to regulatory bodies (national and international) and customers during inspections/audits of the organization.Skills:Microsoft Office (MS Word, MS Excel, MS PowerPoint, MS Project, Outlook)Data Analysis

Abbott Park, Illinois, Us

This managerial position is responsible for overseeing an engineering group as well as a metrology group. The engineering group’s responsibilities covered all aspects of AbbVie Bioresearch Center’s Utilities, Facilities, and Equipment validation program. The metrology group’s responsibilities covered manufacturing as well as laboratory equipment. General responsibilities include:• Managing the Validation Engineering Group with 12 – 16 personnel that included Engineers from entry to principle level, Non-exempt Technicians, Documentation Specialist, and contract resources.• Managing the Metrology Group with 5 personnel that included a salaried calibration coordinator and non-exempt Technicians, as well as contract resources.• Managing Department Budget of over $1.5 Million, including overseeing the development of project proposals, capital expenditure requests, and temporary/permanent headcount requirements. Includes long range planning to respond to demand and anticipated regulatory requirement changes.• Resource planning, recruiting, and performance management to support organizational objectives along with employee development.• Developed department policies to comply with internal policies and external regulatory requirements. • Present information to Regulatory Bodies (National and International) and Customers during inspections/audits of the organization. • All work involved working in a team environment and presenting reports in both written and oral presentation forms.Skills:Microsoft Office (MS Word, MS Excel, MS PowerPoint, MS Project, Outlook)Data Analysis

Tokyo, Jp, Jp

This managerial position was responsible for managing all aspects of Shire HGT’s process and cleaning validation program. General responsibilities include:• Led the development of process and cleaning validation projects using cross functional teams from all stakeholder areas• Acted as a Subject Matter Expert on Food and Drug Administration (FDA) and international regulatory agencies’ regulations for validating processes and cleaning operations.• Developed regulatory (FDA, HC, Japan, EU) submission document (NDAs and MAAs) sections for new and existing drug products• During regulatory audits presented and defended organization documentation• Managed project resources and associated budgets

Durham, North Carolina, Us

Consulted with Pharmaceutical, Biotechnology, and Medical Device companies. Including finished Product and API Manufacturers. Support included:• Project and resource management including presenting information (written and oral) to Project Management Teams to facilitate decision making• Consulted and assisted clients to remediate consent decree and warning letter items• Performed deviation investigations, recommended resolutions, and completed/approved summary documentation• Reviewed equipment design and made recommendations on process requirements based on Industry Standards and Client Policies; Performed Development Work on Cleaning Processes; Assisted with the Development of SOPs and Master Batch Records.• Teaching: Performed formal training programs for sterilization and cleaning validation activities to clients’ employees• Sales generation activities including networking at seminars and conferences, cold calling, and contact development

Milford, Ma, Us

This Director level position led the formation of the Validation Department and Metrology Services Group during the transition from a Research and Development DNA Chemical Plant to an FDA licensed Active Pharmaceutical Ingredient (API) Manufacturing Plant for product launch. General responsibilities included:• Developed internal policies to comply with regulatory requirements. • Resource oversight including the management of sub-contractors as well as identifying permanent resource requirements, defining job descriptions, interviewing, and hiring personnel. Included long range planning of resource demands.• Project management activities, maintaining project budgets, putting together expense proposals, and negotiating contracts with contract companies.• Maintaining a safe work environment through training and coaching.

Durham, North Carolina, Us

Acted as a consultant auditing client’s equipment testing in preparation for a Regulatory Inspection. Assisted a biotechnology firm with equipment testing, and operational procedure development. Performed Cleaning Validation on lab supplies/equipment.

Cambridge, Cambridgeshire, Gb

Managed/Supervised groups that included up to four Senior Validation Engineers, Three Validation Engineers, Three Validation Technicians, a Document Reviewer, a Documentation Assistant, and contract services. Hired, retained, trained, and appraised department employees. Developed department job functions/descriptions with department personnel. The focus on the new job descriptions was to develop career paths for personnel.Coordinated priorities based on the Corporate Objectives with input from internal customers. Developed cost projections for major projects. Set department policies. Enhance department efficiencies through work on a Cycle-Time Team, which was an inter-departmental group. The scope of the team was to develop a new approach to site wide testing process to increase efficiency, decrease costs, and reduce head count requirements.Developed Project Master Plans; Present information to Regulatory Bodies and Customers during inspections/audits; Inspected/Audited subcontractors for compliance with company and industry standards; Designed, implemented, and managed testing (IQ, OQ, PQ) programs to obtain/maintain FDA licensing of manufacturing equipment and processes. All work involved working in a team environment and presenting reports in both written and verbal presentation forms for approval. Wrote/Performed Factory Acceptance Testing (FATs) for new equipment at vendor's facilities. Wrote/Reviewed Standard Operating Procedures (SOPs). Developed and Presented a public presentation on enhancements to cleaning processes which the company wanted to establish as an accepted industry standard.Worked on Change Control/Order Program. Reviewing proposed work to determine the impact on manufacturing equipment and processes. Worked on equipment acquisition teams writing equipment requirement specifications. Review equipment design proposals.Worked on International Corporate Guideline Team to develop worldwide polices.

Brentford, Middlesex, Gb

This was a management training program.Training Assignments:1st - Planning and Scheduling (In Philadelphia US Corp Head Quarters)Developed computerized Spreadsheets (Lotus 123) to assist in scheduling production for all US (including Puerto Rico) manufacturing plants. Generated reports on inventory positions. Communicated production schedule requirements to manufacturing sites.2nd - Packaging Supervisor (In Philadelphia Spring Garden Street Manufacturing)Supervised the 2nd shift packaging area (approximately 40 personnel) for finished product commercial presentations. Staff included operators and mechanics. Conducted reviews and coached employees. Maintained schedules and accountability of the packaging process. Worked with Quality Assurance personnel to maintain required specifications.3rd - Technical Operations – Corp. Engineering (In Philadelphia US Corp Head Quarters)Maintained records of the transition of the manufacture of products from Philadelphia, PA. Plant to Cidra, PR. Plant. Generated reports for tracking projects. Chaired project meetings. Performed runtime cost analysis to determine efficient production line design and one-step manufacturing impact projections.4th – Administration - Sterile Pharmaceutical Plant (In Conshohocken, Pa)Developed and presented seminars to all levels of employees on Continuous Improvement. Topics covered were the Malcolm Baldridge National Quality Award and Internal Customer-Supplier Relationships. Developed a plant self-assessment program for the Malcolm Baldridge National Quality Award Program. Participated as a member of the Continuous Improvement Steering Committee for the manufacturing site. Coordinated work on Cycle Time Improvement projects.

Brentford, Middlesex, Gb

This was an extended CO-OP position, while I attend Widener.Worked in the Maintenance Department reviewing service requests and assigning them to the proper trades. Communicated to requesters on priorities and status of work. Prepared annual budget requirements for the utilities for the entire facility by evaluating usage and working with utility companies to determine project cost increases. Support Department Manager with tracking work completion and assigned special projects. Worked with Safety personnel to address safety issues within Maintenance Department.Wrote and performed testing (IQ, OQ, PQ) for FDA licensing of manufacturing equipment and processes. Develop operating instructions (Standard Operation Procedures). Wrote and performed special studies to determine fault analysis and process improvements. Supervised and trained operational personnel assigned to testing projects. Developed computer integrated data analysis, preventive maintenance tracking, and standard operating procedure review tracking programs. All work included presenting information in written report form following company policies and current Good Manufacturing Processes. Acted as translator with equipment suppliers from Germany during installation activities.

Arlington, Virginia, Us

Clearance: TS/BIPRP QualifiedArmy Achievement Medal, Good Conduct Medal, Overseas Service Ribbon, 59th Ordinance Brigade Certificate of AchievementExtra Duties:• Energy Conservation Noncommissioned Officer (NCO)• Fire/Safety NCOHonorable Discharge

Bachelor Of Science - Bs, Mechanical Engineering

Master Of Business Administration - Mba, Business Administration And Management, General

Associates, Liberal Arts And Sciences, General Studies And Humanities