Workng with Business Process Owners for Systems, Automation, Process, Shipping, Sterilization, Cleaning, QC, and CSV qualification/validation to develop a standard business processes across all of Roche’s thirteen Pharma/Biotech facilities. Configuring and validating a paperless validation tool (ValGenesis) to meet the business needs.

Manage a full time staff of fifteen to perform all facets of validation - automation, equipment, utilities, and cleaning.

Responsible for the generation, facilitation, coordination, and execution of all validation protocols for new or changes to existing automated systems. Oversee and coordinate the activities of the automation validation staff including development, counseling, mentoring and conducting Performance Evaluations. Responsible for the strategic development and technical direction of validation activities primarily associated with automated systems including generation of Validation Master Plans, Validation Project Plans, and Risk Management Reports. Present and defend the validation approach, philosophy and protocols to the FDA and other Regulatory Authorities during inspections. Collaborate with Quality, Manufacturing and Engineering on validation issues and engineering changes. Partner with other Genentech Sites and Corporate Validation to optimize the Validation Program and ensure policies and standards meet the needs of the site as well as regulatory and GAMP requirements. Manage teams of up to twenty contractors and full time employees to support site projects and Tech Transfers to Oceanside. Responsible for recruiting, on-boarding, and successful completion of validation of automation changes to meet aggressive schedules. Established quality metrics to achieve Class A certification and drive continuous improvement.

Managed a team of up to ten people for software development, software quality and service groups to develop, install and support bioprocess control software and systems based on Emerson’s DeltaV DCS. Developed and managed a budget of $2MM/yr for capital improvements and operational expenses. Developed cost estimates and licensing requirements for sales quotes. Reviewed customer requirements and worked with customers to configure off-the-shelf products to meet customer’s specific needs. Developed functional requirements, configuration specifications and test plans for DeltaV bioprocess control software. Worked with customers and marketing to determine new features to be added in quarterly releases. Scheduled and directed the development and testing of the new software features and releases . Lead audits by customers for adhearance to GAMP and standard procedures. Responded to customer complaints and managed the defect tracking system. Scheduled installations, demos, and service visits

Lead automation effort for new Vaccine Manufacture and Sterile Supply facility from concept to operation. Developed scope, estimate and schedule for all automation activities. Managed automation budget of $1.5mm and all automation resources including building and manufacturing systems. Developed and/or managed development of all required sytem life cycle documents for customized and configurable systems. Managed resources for DeltaV code development and testing. Utilized Lean and OEE techniques to minimize capital and operating costs.

Lead development of automation requirements and design for new High Shear tablet manufacturing equipment for new factories in Virginia, Italy and Singapore. Relocated to Singapore from June 2002-Dec 2003. Managed all manufacturing automation efforts from design to qualification including code development (PLC, HMI and Batch), structural testing, FAT, SAT, IQ, OQ, and PQ. Managed project change control and trained local employees on new systems. Selected and managed up to ten automation engineers and programmers for development and testing of software.

Validate, maintain and upgrade the automated inspection systems and other computer controlled equipment in the Sterile Operations area. Responsible for developing and qualifying product configurations, managing change control, troubleshooting material handling and machine vision problems, training mechanical personnel, and maintaining product standards. Also involved in installing new inspection systems, upgrading existing systems, and developing plans for future systems.

Supervised union employees engaged in manufacturing, filling, lyophilization, and inspection of pharmaceutical and biological products on multiple shifts. Responsible for motivating and training personnel, scheduling and assigning work, verifying formula requirements and equipment preparation, checking work performance, providing process knowledge and troubleshooting.

Responsible for providing supervision and direction for the control, maintenance, set-up, and change-over of production machinery and equipment and for proper maintenance of a aseptic production facility that included formulation, filling, sealing, inspection, lyophilization, washing and sterilization processes. Also responsible for providing prompt troubleshooting of malfunctioning equipment and software; and expeditious corrective action in order to reduce delays and disruptions to scheduled production. Generated and analyzed system trends and journals to assist production in problem resolutions and preventive maintenance.

Responsible for performing various quality inspections and audits in production areas for acceptable production characteristics and conformance to procedures and cGMPs.