Working as a Validaiton Engineer at Roche Diagnostics. I work for the Facilities Engineering department.

Collected and documented customer requirements and worked with software development to implement requirements.Provided project status and schedule updates to clients, including time and financial updates.Performed software testing and documentation of testing results.Created a project plan identifying a detailed task list for roll out of a software application to multiple sites across the United States.Worked closely with customers, including executions of joint presentations.Analyzed data feeds, indicated errors and assisted in the cleansing of the data.

Developed and executed SCRs on PLC and HMI applications used to assemble medical devices.Performed validation remediation on various utilities and support systems for a medical device manufacturer.Developed and executed qualification protocols for various utility operations in a pharmaceutical/medical device environment.Managed multiple PLC and documentation projects with a four (4) person technical staff for a pharmaceutical manufacturer.Developed proposal and scope of work documentation (including project costs) for small and medium sized control system projects ($30K to $250K).Provided project status and schedule updates to clients, including time and financial updates.Updated PLC code based on changes to hardware and code functionality.Reviewed PLC source code for utility systems to determine code errors and departures from existing programming standards and made corrections.Created computer system validation (CSV) documentation for existing utility systems to bring the systems into compliance with current standards.Created HMI applications for new and existing control systems based on process requirements and existing area standards.Developed process simulations (simulation of I/O) for testing and validation purposes.Created HMI design documentation for an existing RSView application.Performed the source code review and detailed functional code inspection of the PLC code and HMI displays used to assemble a medical delivery device.Assisted in the creation of a vendor evaluation strategy to be used in the selection of a vendor providing delivery device assembly equipment.Assisted in the creation of various qualification and commissioning documents (FAT, DQ, PQ, and others) for pharmaceutical and medical device manufacturer.

Created functional requirements for various pharmaceutical operations (bioreactors, clarification systems, purification systems, CIP, SIP and other support systems).Designed training materials to be used in the instruction of operators, engineers, and other technical personnel concerning automation functioning, task requirements and general process knowledge.Aided in the modification of documentation based on the requirements for software testing, process changes, and validation.

Sized pumps, meters, and various in-line components for fluid transfer in dairy applications.Designed piping systems to ensure CIP cleanability and SIP steamability.Created matrix charts to control CIP circuit paths and to determine step lengths necessary for proper cleaning.Interacted with vendors of various pieces of process equipment in order to convey specifications, secure spare parts, and resolve product issues.Commissioned a new extended shelf life fluid milk plant, including the trouble-shooting of devices and processes.Conceived engineering solutions for problems encountered in the field during commissioning.Assisted in a modification project for a fluid milk plant including increasing the plant capacity.