Experience

Omni Consulting

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior CQV Engineer

  • Feb 2023 - Present



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Validation Engineer

  • Jan 2014 - Jan 2023



Novartis

• Emeryville

• Validation Contractor

  • Apr 2012 - Dec 2012



BPC Plasma, Inc.

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Validation Engineer

  • Apr 2011 - Apr 2012



PharmEng Technology

• Canada
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Consultant of Bayer Berkeley and Bayer Emeryville

  • Nov 2008 - Nov 2010

  Developed validation protocols and generated final reports for spreadsheet validation. Performed laboratory instrument validation gap analysis. Developed validation plan, risk assessment, URS, and SDD for Empower 2 upgrade from Feature Release 2 to Feature Release 5. Developed and executed validation protocols for Empower 2 software validation on various assays. Compiled validation protocol reports for various assay validations. Developed and executed validation protocols for Sapphire LIMS application patches. Computerized Information System (CIS) and laboratory system validation with GAMP Part 11, FDA guidelines and regulations requirements for the Waters Empower Data Management System, HPLC workstation and other GMP system. Developed and implemented Validation Plans, User Requirements, Functional Requirements, Configuration Specification, IOQ and PQ Protocols, Traceability Matrix etc. deliverables. Developed and implemented Validation Plans, Protocols, and SOPs for Equipment/Instrument Validation such as HPLCs, UVs, Titrators etc. Revised assay SOP to include Empower custom summary report. Performed validation execution and validation document review. Show less



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technical Writer

  • Aug 2007 - Jan 2008

  Developed FMECAs for the equipment that manufactures Insulin strips. Developed and implemented Validation Plans, Protocols, and SOPs for Manufacturing. Equipment and Lab Instrument Validation. Developed the operational and preventative maintenance SOPs for manufacturing equipment. Organized equipment documentation for the turn over packages. Developed product specifications and process specifications. Developed FMECAs for the equipment that manufactures Insulin strips. Developed and implemented Validation Plans, Protocols, and SOPs for Manufacturing. Equipment and Lab Instrument Validation. Developed the operational and preventative maintenance SOPs for manufacturing equipment. Organized equipment documentation for the turn over packages. Developed product specifications and process specifications.



Amgen/Abgenix

• Bio-Chemical Technician

  • Aug 2003 - Jul 2007

  Process and cleaning validation and manufacturing support for bio-reactors, fixed tanks, autoclave and centrifuges. Assembled, disassembled, and performed preventive maintenance of valves, bio-reactors, fixed tanks, and centrifuges. Performed CIP and SIP of bio-reactors, fixed tanks, and centrifuges. Performed validation execution and validation document review. Batch production record and process SOPs drafting. Change control for the manufacturing process. Process and cleaning validation and manufacturing support for bio-reactors, fixed tanks, autoclave and centrifuges. Assembled, disassembled, and performed preventive maintenance of valves, bio-reactors, fixed tanks, and centrifuges. Performed CIP and SIP of bio-reactors, fixed tanks, and centrifuges. Performed validation execution and validation document review. Batch production record and process SOPs drafting. Change control for the manufacturing process.



LeeMAH Electronics

• Manufacturing Engineer

  • Jul 1993 - Sep 2002

  Previewed documentation and created manufacture processes for new product introductions. Acted as technical liaison - resolved technical and quality control issues. Conducted corrective action investigations and improved manufacture processes. Developed and modified manufacture process instructions using Visio and Power Point. Created operation instructions and preventive maintenance programs for various machines. Organized and set up a new production plant by arranging contractors to remodel the facility to obtain approval from City Officials. Managed the project by setting up schedules and meeting deadlines. Purchased new equipment, arranged delivery schedules, and set up and validated equipment. Interfaced with customers and resolved all technical, quality, and material issues. Show less