Bill Beck Email & Phone Number

Union City, California, United States

Fremont, Ca.

Redwood City, Ca.

Generate Turn-Over-Packages and develop / execute User Requirements, Functional Specifications, test protocols, traceability and final reports for custom equipment and control systems. The systems are used for micronization, annealing and spray drying to produce respirable particles.

Fremont, Ca.

Three month validation project with Delta Project Management-Develop traceability matrix, execute test protocols and final reports for a Guava Cytometer and a Biacore T200 molecular interaction analysis system.

Foster City

Four month validation project with Delta Project Management-Develop / execute User Requirements, Functional Specifications, test protocols, traceability and final reports for Isolators, Environmental Controlled Room.

Spencer, In. And San Jose, Ca.

• Develop / execute User Requirements, Functional Specifications, test protocols, traceability and final reports for complex systems with software.
• Successfully interacted with vendors to troubleshoot software and mechanical issues with equipment.
• Resolved various deviations by working closely with Quality Assurance.
• Assured that regulatory requirements for equipment and electronic records/signatures are properly defined and implemented.

Carlsbad, CA

• Developed and executed IQ’s and OQ’s on Tablet Coaters, Blenders, Tableting machines, Capsuling machines and utility systems. Involved in development of validation philosophies, strategies and plan.

Indianapolis, Indiana Area

• Execution of IQ’s and OQ’s on HVAC systems, which supply air to aseptic processing and filling areas. Operational testing of DPT’s, I/P’s, and Bladder (Flow Control) Dampers. Temperature and Humidity mapping and.
• Development and review of commissioning documentation in an Engineering Turnover Package. Writing Final Summary Reports.
• Participation in Final Q.A. Review and Approval.
• Execution of IQ’s and OQ’s for HVAC and utilities in an aseptic environment. This included Temperature and Humidity mapping, HEPA filter testing, Particle Count and Particulate Recovery tests.
• Executed IQ’s and OQ’s on a Collette Vacuum Dryer, Steris cabinet washer, and a Locally Controlled Environment (LCE). Performed Spray Device Coverage Testing using Riboflavin.

North Chicago, IL

• Authored and executed VMP re-validations for a chemical manufacturing facility including reactors, agitators, heat exchangers, pumps, centrifuges, walk-in freezers, and blender/dryers.
• Writing and execution of IQ’s and OQ’s for HVAC, utilities and differential pressure monitoring for aseptic rooms and general offices. Temperature and Humidity mapping w/ Kaye 2000 and temp/humidity chart recorders.
• Participation in Final Q.A. Review and Approval.

Indianapolis, Indiana Area

• Wrote User Requirements Specifications (URS), Functional Specifications, OQ’s, PQ’s and Traceability Matrices for computer control systems (at Eli Lilly) for HVAC.
• Performing audits and Gap analyses of the computerized process control and building automation systems utilizing corporate computer system validation (CSV) guidelines.

Indianapolis, Indiana Area

• Planned, directed and coordinated production assembly lines to improve manufacturing methods, work force utilization, workflow and design/layout of equipment. Wrote technical operating procedures for operators.