Herbert Viola Email & Phone Number

Lodi, California, United States

Responsible for overseeing the day-to-day activities of the Calibration team to maintain the Cepheid asset quality program including the calibration, maintenance and repair of Production, Laboratory, and Facilities/Utilities instrumentation and equipment. Supervise the team to assure compliance with processes/procedures and applicable regulatory requirements to reduce risks and improve compliance and productivity.

Lodi, California, United States

-Lead Calibration Technician for Cepheid Lodi Calibration Department-Lead the day to day activities of the B2 (Consumable MFG) Calibration team.-Directly involved in conducting interview for potential calibration team members. Handle training and mentoring of newly hired Calibration Technicians-Serve as a lead technical resource to customers in the resolution of complex problems and technical issues.-Seek to improve the overall function of the department by anticipating problems and initiating appropriate actions to eliminate them.-Assist in qualification of equipment as needed.-Assist in analyzing new equipment to determine the calibration requirements.-Interacts effectively with peers, internal customers, and management to achieve desired outcomes.-When applicable, perform repairs of instrumentation necessary for maintaining production equipment, laboratory equipment and utilities.-Utilize and maintain secondary and working calibration standards. -Maintain work areas and equipment in a clean an orderly state.-Maintain detailed records of calibration activities and ensure all documentation meets quality and GMP requirements.-Responsible for the calibration and adjustment of equipment to specified tolerances using prescribed Standard Operating Procedures and manufacturer’s manuals.-Perform multi-discipline internal calibrations and simple measurement systems,coordinate with external Vendor calibration and maintain the calibration schedulewith all calibration documentations.-Test, repair and calibrate GX Infinity systems and GX 16 Instruments.-Coordinate and transact GX module via SAP transactions.-Creates purchase orders for necessary products and services.

Lodi, California, United States

-Perform various complex duties inclusive of calibration, testing, maintenance and repairs of electrical, mechanical, molecular diagnostic systems, electronic equipment and instruments in line with established SOP’s, quality and regulatory standards-Assist with the development and improvement of calibration maintenance programs, schedules, work instructions, SOP’s and operational procedures.-Effectively Plan onsite calibration service with external vendor in coordination with equipment/instrument owners to minimize production down time.-Maintain and proactively communicate upcoming calibration due event to internal customers for equipment/instruments requiring offsite calibration by external vendor-Maintain control and traceability related to instruments calibrated internally and by external vendor

Vacaville, Ca

 Collect, compile, measure, summarize, and record data gathered during calibration Recognize out-of-tolerance conditions, perform calibration troubleshooting, diagnoses and corrective action via adjustments, component replacement or correction aspects Effectively interact/collaborate with Manufacturing Operator, Maintenance, Engineering, QA and Validation Perform basic maintenance, troubleshooting and repair of process equipment  Filing / Archival of calibration records Manage priorities with minimal supervision, while ensuring that activities adhere to written procedures and regulations Deliver excellent customer service to internal customers and provide timely and accurate reports and metrics Review calibration procedures as needed to meet internal and external requirements Knowledge of electronics, mathematics, and measurement to calibrate inspection, measurement, and test equipment (IM&TE) Disciplines comprise: Mass, Temperature, Humidity, Vacuum, Length, Optics, Pressure, Dimensional, Force, and Flow to ensure measurement accuracy

Vacaville, Ca

 Perform setup, startup, operation, monitoring, cleaning, and troubleshooting of the Press (Korsch TRP-700 Trilayer/5-layer Tablet Press, Safeline Metal Detector)  Ensure tablets produced are within the product Batch Record specifications (Weight, Thickness, Hardness and Friability) Execute quality in-process testing, sampling, friability and visual inspections  Perform changeover process safely and efficiently Provide support on Protocols (Cleaning Validation, Experimental, IQ, OQ, PQ, Investigation) On a 6-Month Rotational Assignment for the Maintenance/Calibration Group as a Calibration Technician (Oct 2018- Apr 2019)

Vacaville, California

 Perform setup, startup, operation, monitoring, cleaning, and troubleshooting of the Press (Fette Compacting 3090i Tablet Press, PharmaFlex/Kraemer Deduster, CheckMaster and Sani-Matic)  Ensure tablets produced are within the product Batch Record specifications (Weight, Thickness, Hardness and Friability) Implement quality in-process testing, sampling, friability and visual inspections  Perform changeover process safely and efficiently Provide support on Protocols (Cleaning Validation, Experimental, IQ, OQ, PQ, Investigation)

Vacaville, California

 Perform dispensing of raw material in the Pharmacy to support Transdermal, OTC, and Solids Unit Operations Manage the daily schedule of dispensing activities based on priorities Prepare, locate, stage materials (including material movement), and batch records Coordinate with all Unit Operation onsite, Warehouse and Vault activities Perform MFG/PRO (Inventory Management System) transactions for all commercial manufacturing products and experimental runs.

Vacaville, California

 Perform set-up, startup, operation, maintenance, and troubleshooting of ALZA Compounding and Extrusion Equipment (AMK 110L/111L Extruder; Calendar/Laminator; Zenith Polymer Extrusion pump; Metler Toledo Oxygen Analyzer and Scale) Perform set-up, startup, operation and troubleshooting of ALZA Final Lamination/Slitting/Die-Cutting Converting Equipment (Mark Andy 2100/4100 Series) Support Process/Equipment Engineering and Maintenance Team in equipment upgrades and Lean Initiatives Provide information and support on investigations/audit related activities of procedures

Vacaville, Ca

 Perform set-up, assembly/disassembly, start-up, maintenance, and operation of ALZA Electro-Transport Assembly Line Equipment (HIBAR Metering Pumps, Lee Gel Mixers, Temperature Controllers, TR60 Four Side Seal Packaging Machine-Doyen/HarroHofliġer, Zone2 Automated Lamination and Assembly System-ATS/Kinematics, Zone1 Automated Bottom Housing Assembly System-ATS/Remmele, Curing Chambers-Despatch/Ransco) per SOP. Perform set-up, startup, operation, and troubleshooting of Pouching Unit Equipment (Circle 3, 6, 7 and Bodolay 2)

Vacaville, Ca

 Perform start-up and operation of equipments per SOP and Master Formulae/Package Order in addition to completing all documentations as required.  Perform cleaning of processing rooms and manufacturing equipments, and preparing controlled documents and materials Perform basic adjustments and corrective/ preventive actions to equipment and process as necessary Maintain housekeeping (5S program) of areas and equipment

Hercules, Ca

• Support new product launches by ensuring efficient transfers to Manufacturing• Assist Manufacturing Engineers in managing process improvement and equipment projects to improve yield, efficiency and equipment availability• Provide timely and efficient problem resolution ideas resulting in stable and more capable processes• Support implementation of SOP, documentations, validation protocols, and studies on assigned equipment

Hercules, Ca

Performs visual inspection, labeling and packaging of laboratory products used for diagnosis of patients and research in biochemistry and immunology. Tasks include following written standard operating procedure and utilizing good manufacturing practices.

San Francisco, Ca

Performs a variety of tasks in handling customer and ATM deposits in a labor-intensive, production environment that include receiving deposits from armored carriers, open and verify deposits, prepare adjustments to deposits as required, credit individual accounts, research medium to complex out-of-balance transactions and operate sophisticated currency counter equipments.