Peter Gil Email & Phone Number

Raleigh-Durham, North Carolina Area

Provide support for Computer Systems Validation (CSV) activities for corporate initiatives and to provide support to affiliate sites and assist in developing global standards and validation strategy.

Lynchburg, Virginia Area

I teach Biology 101 and Creation Studies in Spanish and English. Currently working on a full translation to Spanish of Creation Studies CRST290 course.

Forest, Va

Forest, Va

Extensive hands on GMP validation generalist with experience managing projects, driving schedule, vendors, deliverables, as well as performing detail deliverable generation work product. Initial role was Computer Validation Specialist and was promoted to successively higher levels of responsibility. Managed all aspects of FDA regulated qualification activities for all process equipment, packaging (including first high-speed serialized bottling line for Teva worldwide), facilities and computer systems at the Forest, VA site (largest solid-dose manufacturing facility for Teva North America)Authored URS, FDS, DDS, Risk Assessment and Validation Project Plans. Authored documents and performed Factory Acceptance Testing, Site Acceptance Testing, Commissioning, Installation/Operational Qualification, Performance Qualification, Computer Systems Validation including 21 CFR Part 11 for many types of process and packaging equipment, facilities (HVAC, USP water, clean compressed air) and Building Automation/Monitoring systems associated with solid-dose pharmaceuticals manufacturing.List of specific systems is as follows:• Automated packaging lines (bottle and blister-pack) including Serialization• Tablet presses (including double-sided, core-coating and multi-layered)• Encapsulators (including beads, tablets and micro-tablets with vision)• Fluid Beds• Hi-coaters• Rotating blenders of many types (V, double-cone, cross-flow, bin)• High Shear Granulators• High speed vision inspection systems (InspeCap, InspecTab)• Tablet Imprinters• Extruders• Mills of various types• Ovens of various types including vacuum ovens• Stability chambers, cold storage units and warehouses• Lyophilizers• Automated Parts Washer• High speed Tablet and capsule weight sorters• HVAC, Clean Compressed Air and Water Systems: USP Deionization systems and Hot sanitized, Reverse Osmosis with EDI systems

Lynchburg, Virginia Area

Same role as Senior Staff Engineer at Ericsson. The Manufacturing Technology group, of which I was a part, was sold to Flextronics. The job function did not change.

Lynchburg, Virginia Area

Provide data extraction, statistical analysis and training support for the cellular phone verification group whose function is to take new products from design to high volume manufacturing.• Developed several applications using Cornerstone and CEL (nearly thirty thousand lines of code) that facilitate data extraction from an Oracle database and create a number of statistical reports including process capability, defect paretos and process behavior charts that also enable quick and efficient sharing of data between the Verification group and R&D.• Provided installation support, maintenance, technical support, training, and continual enhancements to Cornerstone based applications running in a networked MS-Windows NT 4.0 environment in Virginia, North Carolina, Mexico and Brazil.• Provided consulting to engineers in Design of Experiments (DOE), Six Sigma and basic statistical techniques.• Completed Ericsson Quality Management Institute Six Sigma Black Belt training.

Boynton Beach, Fl

Quality Information System developer and administrator for Motorola Paging Products Group World Headquarters.Principle engineer responsible for the design, development and implementation of the quality information system used to monitor all major aspects of the manufacturing process (nearly fifty thousand lines of code). This system was adopted at several Motorola facilities including Mexico and Puerto Rico.Provided installation, maintenance, support, training, and enhancements to all RS/1 based applications running in a networked HP-UX and MS-Windows NT 4.0 environment for Boynton Beach and other Paging facilities worldwide. (Developed and delivered 40-hr training course in Spanish for Mexico & Puerto Rico facilities.)Developed Real–Time data gathering systems, Control Charting, alert notification via e-mail and pagers and reporting applications to monitor major product and process parameters. Involved in process characterization efforts, training, and consulting of engineers in Design of Experiments (DOE), Six Sigma and other formal problem solving techniques.Completed Motorola University Six-Sigma Black Belt training.

Orlando, Florida Area

Managed the technical aspects of third party relationships with vendors acting as value-added resellers, cooperative marketing partners, distributors and system integrators as well as new customers. Responsible for developing integrated manufacturing solutions as well as joint product demonstrations and training, answering RFP's and assisting the customer with all technically related issues before, during and after the sale.

Miami, Fl

Responsible for all aspects of product development, from design of specifications to preparation of manufacturing protocols and scientific reports. Improved time to market and product quality by using advanced software tools for statistical data analysis and design of experiments. Part of a team that developed Radial Partition Immunoassays for Thyroxine (T4) and Triiodothyronine (T3) in blood serum (published).

Doctor Of Philosophy (Phd-Abd), Biochemistry

Ph.D. Biochemistry (ABD)

Bachelor Of Science (Bs), Chemistry

Activities and Societies: B.S. Chemistry B.S. Chemistry (Pre-med)