Experienced project manager with excellent client and multi- project management skills. Action-oriented with strong ability to communicate effectively with technology, executive and business audiences. Broad pharma and biotech project background including capital planning, scope, budget, construction project and schedule management, mechanical and HVAC system design.
Responsible for a variety of US and international capital projects. Managed budgets, schedules, contracts, contractors, and design teams as required to evaluate, construct and improve facilities, programs and systems. Managed scope, contracts and construction teams. Reported to executive management to inform, update and request capital as needed. Provided project management and engineering support for intra-site equipment transfer projects (relocating fluid bed, granulation, blending, packaging, bottling and labeling equipment) and management of multi-phase process equipment re-installation, commissioning, startup and validation. Provided project management, planning and direction for implementation of a validated global Computerized Maintenance Management System (Maximo) thoroughly integrated with SAP. Successfully managed the design, configuration and deployment of system at three sites Provided project management, engineering and document review for manufacturing facility expansions, new CDC Laboratories, Vivarium and Solid Dosage facilities in France. Developed Global Capital Policy, Capital Authorization Request Procedure and Project Management Guidelines. Served on the Quality Standards Review Committee, as well as the Crisis Management Team to establish QA/QC/EHS corporate Standards and SOPs. Provided system review and startup support to meet the building completion deadline. Supported the facility designs for HVAC and potent compound upgrades to CDC facilities. Initiated multi-level on-site French tutorial classes to improve communication with our French colleagues.
(Oct 2013 - Present) The forementioned position (and the department) was eliminated in 9/2013 after Cephalon was acquired by Teva. This event provided me the rare opportunity of paid time off to travel the world, climb Everest, meet and marry my husband, and care for my aging parents. As a result, I am ready and eager now to rejoin the engineering management arena with renewed energy and an even greater perspective of what adds value for my company, colleagues and customers.
Managed key PMO projects at ARI bio-pharmaceutical production site. Planned and executed first annual plant PM shutdown and implemented global Maximo (CMMS) system. Provided engineering expertise to all departments. Identified, prioritized, staffed and implemented process improvement projects to meet business objectives. Served as primary interface with project teams, stakeholders, project champions, sponsors, and executive governance steering committees. Created alignment between site and corporate management teams in manufacturing, process development, engineering, maintenance, utilities, EHS, QA, regulatory and validation departments. Produced tools, methodologies and training to facilitate best practices for project management and benchmarking. Executed multi- department business process streamlining sessions for process improvements and cost savings. Developed future state strategies, goals and objectives, metrics and associated budgets.
Managed capital projects ranging from $2MM to $20MM each. Organized and planned engineering and construction of specific project assignments, defined project scopes, established budgets and schedules, coordinated design teams and programmed space requirements for pharmaceutical research and manufacturing. Approved A&E design firms, consultants, contractors, and vendors and obtained commitment of resources and capital from upper management. Managed teams from concept to commissioning, validation, and turnover. Coordinated utility shutdowns and tie-ins and enforced site safety program. Oversaw validation, reviewed documentation and protocols, and ensured design compliance with building codes, cGMP, regulatory, and company policies and procedures.
Consulted to management of Bayer Biological Products Manufacturing Facility (plasma /sterile filling processing plant) in engineering compliance by identifying FDA regulatory trends, determining possible impact on sterile and non- sterile facility and processes, and advancing relevant and critical technical project proposals to successful completion.
Managed capital projects from $0.6MM to $14MM in pharmaceutical research and manufacturing. Organized and planned engineering and construction, defined project scopes, established budgets and schedules, selected and managed design and construction teams. Projects varied from pharmaceutical technology research lab and manufacturing renovations to central utility plant and clean steam boiler expansion, vivarium, office building renovation and penicillin facility decontamination.
Designed industrial HVAC and piping systems for major pharmaceutical airline, food and newspaper clients. Developed energy studies, coordinated design layouts between engineering disciplines, prepared specifications and conducted QA design coordination checks.
Concentration in HVAC
Student Government Vice President
51 credits earned toward M.B.A.
(expected completion 12/15)
ISPE, ASHRAE, PDA, SWE, HBA
Advanced level of fluency in French
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