SKILLS & QUALIFICATIONS SUMMARY
- Twelve Years of Validation Process Management
- Thorough Knowledge of ISPE Baseline Pharmaceutical Engineering Guide and GAMP
- Initiative strategy development and implementation
- Bachelor of Science Degree(s) - Chemistry & Chemical Engineering
- Staff development and supervision
- Excellent communication: written and verbal
- Multi-lingual proficiency - English, Spanish and Portuguese
- Prioritization and multi-tasking
- Comprehensive computer literacy: Microsoft Office and AutoCAD
2008 - 2009 Validation Engineer, Confidential,
Performed temperature mapping for validation of ultra low freezers, refrigerators and incubators. Performed packaging and shipping validation for soft tissues, skin grafts and bone product.
2006 - 2008Validation Manager, Confidential
Support preparation of the chemistry, manufacturing and controls portion for CMC/CTD submissions. Create master validation plans and validation protocols including: process validation, equipment validation, media fill validation, cleaning validation, sterilization validation, and utility validation. Generate final reports for all validations plans and protocols. Manage the validation department, and coordinate with other departments to meet the production and validation needs of pilot plants with aseptic production facilities.
2002 - 2006Validation Engineer, Confidential
Prepared, executed, and generated reports in regard to commissioning plans, SAT, FAT, I/O hardware Loop Test, IQ/OQ/PQ and qualification plan of automated high speed solid and liquid filling machines, primary packaging equipment and cartoners. Developed calibration protocols, control and alarm tests using schematics, flow charts, P & ID charts and machine functional descriptions.
2001 - 2002Process Engineer, Confidential
Prepared, executed, and generated reports in regard to fill volume studies for aseptic vial and syringe products like Smallpox, Anthrax, hormones, protein conjugates, DNA vaccines, oligosacharides, and polypeptides. Generated and reviewed SOPs. Conducted terminal sterilization cycle development studies.
1997 - 2001 Technical Support Specialist, Confidential
Responsible for documentation and performance of IQ/OQ/PQ and Y2K. Comprehensive calibration and repair of analytical equipment such as HPLC, UV-VIS, GC, analytical balances, Karl Fischer titrators, FTIR, IR instruments, gas generators, and dissolution baths.
1996 - 1997 Research Assistant, Confidential
Maintained the integrated studies of Hammets constant to non-organic compounds such as silicates and borates by theoretical prediction of their ionization energies with the corroboration of experimental data, using mass spectroscopy.
Masters in Business Administration (MBA)
Bachelor of Science (BS) Degrees - Chemistry, Chemical Engineering, Purdue University emphasis: Environmental Engineering
1990 - Present American Chemical Society
2002 - Present International Society for Pharmaceutical Engineering (ISPE)