Daniel Perez, Pmp Email & Phone Number

Brentwood, Tn, Us

Provide leadership to the Engineering Project Management organization responsible for building newregulated Supply Chain Centers worldwide. Recruited, manage and provide performance feedback for one Project Engineer.Completed the design and construction of a €7MM GMP facility in Belgium for cryopreserving starting materials used for the manufacture of Cell and Gene Therapies.Completed the facility layout and developed full process design drawings for a new 3,000 sqft Logistic Center in Stevenage, UK.Support the design and construction of new facilities in Paris, France and Santa Ana, California to support logistics, biostorage and GMP manufacturing supporting cell and gene therapies. Manage over $30MM in capital for projects.

Brentwood, Tn, Us

Chief Architectural and Process Designer of new FDA regulated Supply Chain Centers worldwide.Managed the conceptual development, architectural design and process design of two new 25,000 sqft Logistics & Biostorage Supply Chain Centers in the United States. Completed the facility layout and developed full process design drawings for a new 2,500 sqft Logistic Center in Singapore and a 3,500 sqft Logistic Center in Sydney, AUS.Developed drafting program to prepare Facility Layouts, 3D modeling of Facilities as well as 3D Bill of Materials drawing packages for all processing cells used at all new and existing facilities in the Cryoport Systems network. Modeled over 1000 parts/components for processing cells.

Irvine, Ca, Us

Lead plant engineer supporting all capital projects planning and execution, quality systems and GMP lifecycle documentation generation, equipment and system troubleshooting and process improvement initiatives.Completed $750K project to install a new Purified Water Generation and Distribution System, a new Pure Steam Generator and sanitary process piping allowing for increased clean utility capacity. Developed installation layout, installation & qualification strategy and developed & executed all lifecycle documents including URS, FS, SDS, TM, IOQ and PQ. Developed new P&ID drawings and added calibration & maintenance into CMMS system.Completed $160K project to install 4 new Air Compressors and a new 1000L Bulk Nitrogen Storage Tank. Established installation and qualification strategy and developed and executed all lifecycle documents including URS, FS, TM, IOQ and PQ. Developed new P&ID’s drawings along with new CAD title block for company.Completed changes to the machine PLC ladder logic as well as other mechanical improvements to an Aseptic Vial Filling and Capping Line to reduce in-process reject rates from an average of 15% to below 5%. Developed new procedure for set-up, operation and changeover of the line and provided training and coaching to operators. Provided leadership to 3 facility shutdowns, developing and obtaining approval for a shutdown plan & a shutdown final report, establishing requirements for placing and returning the facility from shutdown conditions, developing work schedules for contractors and creating a controlled binder with all the shutdown related documentation.

Bethlehem, Pa, Us

Managed the development and implementation of a capital program to double the capacity for a high profit product platform as part of the overall growth strategy of the US business. Developed a capacity model to determine current capacity and the requirements to double production capacity. Established a phased 5-year/~$70MM capital plan to meet strategy including equipment, facility, utility, qualification, process validation and test method validation requirements.Managed $6MM first phase project for the purchase, and installation of a new IV container making line. Completed FAT, installation, startup, training, SAT, SOP’s development as well as all Equipment Qualification and Process Validation documentation. Developed equipment installation layout and completed facility modifications required for installation of new equipment. Developed and managed change control for project.Obtained approval for $12.5MM phase two project to re-develop the container platform as well as design and purchase a brand new Form, Fill and Seal IV Container Line to manufacture the new IV container.

New Brunswick, Nj, Us

Supported the implementation of the Site Capital Master Plan by conducting assessments of facility and utility system and executing associated projects from concept through completion Developed scope, established business case, obtained capital funding approval ($2MM) and completed design of a new Compressed Air System. Established User requirements including ISO Air Quality criteria, selected new equipment suppliers and installation contractors, established sanitary construction guidelines and established a plan to install and transition to new system without interrupting manufacturing operations.Developed scope, established business case and obtain approval for the design of new HVAC system to provide air to a Compounding area. Successfully managed an 11-day Plant Shutdown from project list development through Lessons Learned close out meetings. Managed weekly planning meetings before shutdown as well as daily meetings during shutdown to successfully complete all projects and initiatives. Ensured all contractors and project managers adhered to shutdown specific rules and assured that a clean plant was turned over to Operations as per Planning Department’s deadlines.

Hayward, Ca, Us

Developed and implemented Equipment and Facility related Capital Projects as well as provided technical and engineering design support to the Hayward, CA manufacturing facility.Completed capital project to build three new airlocks to separate non-rated corridors from GMP hallways. Installed new terminal HEPA filters in each airlock, provided instruments to measure differential pressure and completed air balancing of HVAC.Completed a control upgrade of three tablet presses to include weight control capabilities as well as CFR Part 11 compliance.

Provided technical and engineering project management support to five manufacturing sites in the United States. Hired and supervised a staff of three Project Managers with direct responsibility over a portfolio of over 50 capital projects totaling over $30 million. Responsible for team's day to day operations, project loading and assignment and performance management.Completed $7.5 million remodel of manufacturing operations at California facility, resulting in a 15% increase in capacity and the transfer of high profit products in support of Cost-of- Goods-Sold reduction strategy. Expanded R&D product development capabilities and provided an increase in capacity for future commercial manufacturing by completing $2 million remodel of manufacturing operations at California manufacturing facility.Designed and developed database to manage Project Portfolio department which allowed managers to track cost, cash flow, timelines and provided the ability to create detailed reports based on senior management needs. Conducted high-level engineering evaluations of over 35 new products, providing estimated cost and schedule per possible manufacturing site to senior management and contributing to development of 3-year capital budget plans.

Developed and implemented capital projects in support of five manufacturing sites in the US. Supervised up to two contract employees.Led project to relocate and install manufacturing equipment supporting the transfer of high volume and high profit products from a closed Puerto Rico facility to a remodeled CA facility. Earned Technical Operations Recognition Program Achievement Award in 2008 for this project.Averted possible customer supply issues of products being transferred by closely supervising contractors and reducing equipment installation schedule by 3 weeks. Completed installation of equipment in support of new product line introduction at a New York manufacturing facility. Supported aggressive completion schedule by reducing equipment startup time by 56%. Earned Technical Operations Recognition Program Achievement Award in 2009 for this project.

Developed and implemented capital projects for four manufacturing sites in the US and R&D operations. Supervised up to five contract employees at a time. Promoted from Engineer I to Engineer II in 2005.Managed $10 million expansion, which resulted in an increase of 50% in capacity for the Product Development group at California facility.Spearheaded negotiations with international equipment vendor to purchase pharmaceutical equipment, saving more than $200K under asking price.Completed $3 million expansion manufacturing operations at a Puerto Rico facility to transfer the top grossing oral contraceptive product in-house, saving the company up to $5M per year in operating costs for the product.Introduced new equipment and launched new Gum manufacturing facility in New York which centralized all manufacturing operations and increased the manufacturing capacity by 40%.Implemented new technologies and completed $550K upgrade of two weighing rooms in Puerto Rico facility, resulting in significant reduction in airborne contaminants and associated exposure to manufacturing operators. Technology was rolled out company-wide.Completed over 20 studies to determine seal parameters for blister packaging machines at a Puerto Rico facility, leading to an 85% decrease of related customer complaints.

New Brunswick, Nj, Us

Managed the capital appropriation process supporting corporate and local goals and provided project management support to three manufacturing departments.Developed new capital appropriation process that reduced the approval cycle time on local requests by 45% and minimized rework, reducing rejected projects by 25%.Completed a two week Johnson and Johnson Process Excellence Green Belt Training. Supported changeover reduction Project that helped reduce by 25% the time required for minor cleanings between manufacturing batches in compression machines. Succeeded in transforming tableting area by eliminating 11 presses and introducing four technologically advanced presses, which allowed a reduction in headcount of five persons and a reduction in the departmental budget of 20%.

Bs, Industrial Engineering Technology

Mba, Project Management