Cuong Nguyen Email & Phone Number | • BS in EE with 18 years plus of professional experience. • 18 Years of hands-on Computer System Validation, Manufacturing and Packaging Equipment Installation and Qualification, Test Method Validation, R&D, 21 CFR Part 11/ Part 820 Regulations, ISO 14971, and GAMP5. • Worked with many Automation and process systems like Track and Trace (Serialization), DCS, PLC, HMI, custom software systems etc. for unit operations like compounding, batching, cleaning, freeze drying, CIP, SIP, filling, packaging. • 8 years of lead/project management experience for computer system validation. • Interfaced directly with FDA during audits as a CSV subject matter expert at Boston Scientific and St. Jude Medical. • 5 years of Enterprise Resource Planning (ERP) software design, development, and validations. • 6 years of experiences in Remediation projects with extensive validation/QA/QE experience in a plant environment. Handled complete life cycle including IQ/OQ/PQ protocol creation, testing root cause analysis of system software errors after release to production, writing non-conformance and investigation reports, corrective (change control) and preventive action (CAPA), risk assessment, PFMEAs, etc. • 2 years of hands-on programming experience with PLC/SCADA/DCS etc. • 7 Years of experience in GxP Sterile Aseptic pharmaceutical Packaging with Bosch Packaging, Upsher-Smith Laboratories, and Pharmaforce (temperature mappings, cleaning validations) • 10 years of experience in GxP Medical Devices industry. • Working relationships with a many Pharmaceutical and Medical Devices client companies such as St. Jude Medical, Amgen, Eli Lilly, Roche, Boston Scientifics, Mallinckrodt, Genentech, Pfizer, J&J, Hollister-Stier, Merial, and Cardinal Health while working for Bosch • Excellent team player. Works well with management, vendors and production maintenance personnel. • Single, U.S. Citizenship. Open to relocate and travel as required.

Cuong Nguyen

• BS in EE with 18 years plus of professional experience. • 18 Years of hands-on Computer System Val...
Minneapolis, Minnesota, United States

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Cuong Nguyen’s Email cuong.nguyen@philips.com

Cuong Nguyen’s Phone Numbers +1 800-257-****

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Cuong Nguyen’s Location Minneapolis, Minnesota, United States

Cuong Nguyen’s Current Industry Philips

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Work Experience

Philips

Sr. Quality Engineer

2018-01-01 00:00:00 - Present

Monteris Medical

Sr. CSV Engineer

2017-04-01 00:00:00 - 2017-12-01 00:00:00

Pharmaforce

Sr. Validation Engineer

2016-03-01 00:00:00 - 2017-01-01 00:00:00

Johnson And Johnson

Sr. Validation Engineer

2015-09-01 00:00:00 - 2016-01-01 00:00:00

Cmn Validation Services

Validation Manager

2015-01-01 00:00:00 - 2015-06-01 00:00:00

Upsher Smith Laboratories

Sr. System Engineer

2014-02-01 00:00:00 - 2014-12-01 00:00:00

Southeast Asia Medical

Sr. Computer/Software Validation Enginner

2013-06-01 00:00:00 - 2013-12-01 00:00:00

Maetrics

Sr. CQT Engineer

2013-01-01 00:00:00 - 2013-05-01 00:00:00

Aerotek

Sr. System Validation Engineer

2011-11-01 00:00:00 - 2013-01-01 00:00:00

Stryker Medical

Sr. SW Validation Engineer

2010-03-01 00:00:00 - 2010-11-01 00:00:00

St Jude Medical

Sr. Hardware Manufacturing Engineer

2008-08-01 00:00:00 - 2009-10-01 00:00:00

Bosch Packaging Technology

Sr. Computer Validation Engineer

2003-03-01 00:00:00 - 2008-04-01 00:00:00

Boston Scientific

Automation System and Software Test Engineer

2000-06-01 00:00:00 - 2003-03-01 00:00:00

Mallinckrodt

Software Test Engineer

1996-06-01 00:00:00 - 2000-06-01 00:00:00

Skills

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Languages

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FAQ About Cuong Nguyen

Cuong Nguyen is located at
Minneapolis, Minnesota, United States

Cuong Nguyen is a • BS in EE with 18 years plus of professional experience. • 18 Years of hands-on Computer System Validation, Manufacturing and Packaging Equipment Installation and Qualification, Test Method Validation, R&D, 21 CFR Part 11/ Part 820 Regulations, ISO 14971, and GAMP5. • Worked with many Automation and process systems like Track and Trace (Serialization), DCS, PLC, HMI, custom software systems etc. for unit operations like compounding, batching, cleaning, freeze drying, CIP, SIP, filling, packaging. • 8 years of lead/project management experience for computer system validation. • Interfaced directly with FDA during audits as a CSV subject matter expert at Boston Scientific and St. Jude Medical. • 5 years of Enterprise Resource Planning (ERP) software design, development, and validations. • 6 years of experiences in Remediation projects with extensive validation/QA/QE experience in a plant environment. Handled complete life cycle including IQ/OQ/PQ protocol creation, testing root cause analysis of system software errors after release to production, writing non-conformance and investigation reports, corrective (change control) and preventive action (CAPA), risk assessment, PFMEAs, etc. • 2 years of hands-on programming experience with PLC/SCADA/DCS etc. • 7 Years of experience in GxP Sterile Aseptic pharmaceutical Packaging with Bosch Packaging, Upsher-Smith Laboratories, and Pharmaforce (temperature mappings, cleaning validations) • 10 years of experience in GxP Medical Devices industry. • Working relationships with a many Pharmaceutical and Medical Devices client companies such as St. Jude Medical, Amgen, Eli Lilly, Roche, Boston Scientifics, Mallinckrodt, Genentech, Pfizer, J&J, Hollister-Stier, Merial, and Cardinal Health while working for Bosch • Excellent team player. Works well with management, vendors and production maintenance personnel. • Single, U.S. Citizenship. Open to relocate and travel as required.

Cuong Nguyen currently works in the Philips |

No Languages Available

Cuong Nguyen has prior
experience in the following industries:
Monteris Medical | Pharmaforce | Johnson And Johnson | Cmn Validation Services | Upsher Smith Laboratories | Southeast Asia Medical | Maetrics | Aerotek | Stryker Medical | St Jude Medical | Bosch Packaging Technology | Boston Scientific | Mallinckrodt

Cuong Nguyen has the following professional experience:
Philips | Monteris Medical | Pharmaforce | Johnson And Johnson | Cmn Validation Services | Upsher Smith Laboratories | Southeast Asia Medical | Maetrics | Aerotek | Stryker Medical | St Jude Medical | Bosch Packaging Technology | Boston Scientific | Mallinckrodt