Stephen Yu

Stephen Yu Email and Phone Number

Retired
Stephen Yu's Location
Hockessin, Delaware, United States, United States
Stephen Yu's Contact Details

Stephen Yu personal email

n/a

Stephen Yu phone numbers

About Stephen Yu

Technical manager with a diversified experience in the pharmaceutical and food industries, managed engineering / maintenance team for major U.S. Corporations, and the ability to plan, implement and achieve strategic goals and objectives. Key talent and expertise:•Planning, organizing, and directing engineering organization.•Developing operational strategies, master planning and capital budget management.•Capital Project Management: engineering design, construction, commission and validation.•Risk Assessment and Risk Management Process.•Regulatory requirements: FDA and EU GMP, validation, environmental & safety, building codes etc.•Manufacturing and packaging process automation.•Lean transformation, six sigma tools, OEE metrics, and DOE methodology.•Biotechnology and aseptic process & facility design/construction.•High purity utility system design and operation.Specialties: •Pharmaceutical and biotech process / facility design.•Pharmaceutical regulatory compliance requirements•Technology transfer process•Risk assessment & Risk Management process

Stephen Yu's Current Company Details

Retired
Stephen Yu Work Experience Details
  • Bayesian-Consulting Llc
    Managing Director
    Bayesian-Consulting Llc Nov 2009 - Jan 2017
    Provide consulting services to BioPharm industry in risk management, process development, and GMP compliance. Develop Bayesian probabilistic risk model for financial service industry.
  • Be&K
    Principal Process Engineer
    Be&K Jan 2008 - Nov 2009
    London, Gb
    Architectural and Engineering company serving the biopharm industry.
    View
  • Astrazeneca Pharmaceutical
    Director, Production Engineering
    Astrazeneca Pharmaceutical Sep 2001 - Dec 2007
    Supervise a group of project managers for implementing capital projects in production sites.

Stephen Yu Skills

Validation Gmp Change Control Fda Technology Transfer Six Sigma Process Simulation Biotechnology Pharmaceutics Manufacturing R&d V&v Process Control Quality Auditing Design Of Experiments Engineering Chemical Engineering Project Management 21 Cfr Part 11 Regulatory Affairs Lifesciences Capa Medical Devices Quality Assurance Quality Management Root Cause Analysis Computer System Validation Sop Quality System Process Engineering Pharmaceutical Industry Quality Control Aseptic Processing Process Optimization Biopharmaceuticals Regulatory Requirements Commissioning Gxp Iso 13485 Hazop Analytical Chemistry Gamp Cross Functional Team Leadership Vaccines Regulatory Submissions Iso Chemistry Commercialization

Stephen Yu Education Details

  • New York University
    New York University
    Chemical Engineering

Frequently Asked Questions about Stephen Yu

What is Stephen Yu's role at the current company?

Stephen Yu's current role is Retired.

What is Stephen Yu's email address?

Stephen Yu's email address is st****@****eca.com

What is Stephen Yu's direct phone number?

Stephen Yu's direct phone number is +130236*****

What schools did Stephen Yu attend?

Stephen Yu attended New York University.

What skills is Stephen Yu known for?

Stephen Yu has skills like Validation, Gmp, Change Control, Fda, Technology Transfer, Six Sigma, Process Simulation, Biotechnology, Pharmaceutics, Manufacturing, R&d, V&v.

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