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Jenni Chi

Validation Engineer III

Senior Validation Engineer at Hyland's, Inc.

Greater Los Angeles Area

Section title

Jenni Chi's Email Addresses & Phone Numbers

Jenni Chi's Work Experience

Hyland's, Inc.

Validation Engineer III

May 2013 to Present

PolyPeptide Laboratories

Validation Supervisor

September 2009 to May 2013

PolyPeptide Group

Validation Specialist II

November 2001 to September 2009

Jenni Chi's Education

Bachelors of Science

Bachelor of Science (BS) Biology

University of California, Riverside

Bachelor of Science (BS) Biology General

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Innovative
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Based on our findings, Jenni Chi is ...

52% Left Brained
48% Right Brained

Jenni Chi's Estimated Salary Range

About Jenni Chi's Current Company

Hyland's, Inc.

• Develop and generate validation protocols associated with equipment, systems, and processes • Directly and indirectly support the execution of validation protocols (IQ/OQ/PQ/CVP), including the collection of samples, data, and completes protocol attachments • Directly and indirectly compiles and analyzes validation data and prepares reports • Ensures that Validation management is notified of deviations from protocol criteria,...

Frequently Asked Questions about Jenni Chi

What company does Jenni Chi work for?

Jenni Chi works for Hyland's, Inc.


What is Jenni Chi's role at Hyland's, Inc.?

Jenni Chi is Validation Engineer III


What is Jenni Chi's personal email address?

Jenni Chi's personal email address is j****[email protected]


What is Jenni Chi's business email address?

Jenni Chi's business email addresses are not available


What is Jenni Chi's Phone Number?

Jenni Chi's phone (**) *** *** 314


Who are Jenni Chi's colleagues?

Jenni Chi's colleagues are Looks Geeganage, J.P. Borneman, Carlos Valencia, Renee Beren, and Annie Chen


About Jenni Chi

📖 Summary

Validation Engineer III @ • Develop and generate validation protocols associated with equipment, systems, and processes • Directly and indirectly support the execution of validation protocols (IQ/OQ/PQ/CVP), including the collection of samples, data, and completes protocol attachments • Directly and indirectly compiles and analyzes validation data and prepares reports • Ensures that Validation management is notified of deviations from protocol criteria, supports the identification root causes and resolutions • Coordinates the scheduling of validation protocol executions and testing with affected departments and personnel; this includes Manufacturing, Quality Assurance/Control, and Maintenance. From May 2013 to Present (2 years 8 months) Validation Supervisor @ • Developed and generated equipment and cleaning validation protocol • Performed the validation and writing the summary report • Performed calibration and scheduling preventative maintenance with outside contractors • Managing schedules with production regarding calibration and validation work • Supervised and reviewed the work of new trainees • Revising and implementing validation procedures, execute validation change controls and oversee documentations From September 2009 to May 2013 (3 years 9 months) Validation Specialist II @ • Developed and generated equipment and cleaning validation protocol • Performed the validation and writing the summary report • Performed calibration and scheduling preventative maintenance with outside contractors • Managing schedules with production regarding calibration and validation work • Revising and implementing validation procedures, execute validation change controls and oversee documentations From November 2001 to September 2009 (7 years 11 months) Validation Engineer/Supervisor @ • Supervised and trained the Process Validation group that consisted of 3 to 4 employees • Reviewed, edited and signed validation protocols and reports • Updating/discussing with management of project status, presenting presentations/training sessions, problem solving and schedule planning  Specific Tasks and Projects included: • Developed a Performance Qualification (PQ) protocol and summary for the fogger machines new disinfectant fogging solution • Executed a PQ validation and generated the summary report on the assembly line that was relocated • Developed a Process Validation (PV) protocol and summary on new medications manufactured (i.e. compounding to filling process) • Generated Revalidation protocols for existing medications due to changes • Executed Cleaning Validation and generated summary reports for the new medications (implementations of the finished validation projects to its corresponding SOP(s)) • Developed PQ protocol and summary report along with executing the PQ for four assembly manufacturing lines (i.e. Uro-Jet assembly line, Dilute-A-Jet assembly line, etc) • Revised the protocol and SOP for the Gamma Dose Audit method, executed the process and generated the summary reports for each category audited • Generated and reviewed all cleaning validation reports initiated • Generated addendums to protocols that need re-validating • Generated summary reports for Filter Validations From May 2000 to November 2001 (1 year 7 months) Validation technician @  Performance of work included: • Wrote protocols and summary reports • Execution of written protocols with group members  Projects included: • Writing Performance Qualification (PQ) protocol and summary report along with executing the PQ for the LOJ assembly lines • Writing Process Validation (PV) for the new Cozzoli machine medications • Data analysis for facility’s stopper oven validation  Collaborated projects included: • Execution of Autoclave and Despatch ovens • Cleaning validation executions • Execution of TOYO molding machine execution From November 1999 to May 2000 (7 months) Bachelor of Science (BS), Biology @ Bachelors of ScienceBachelor of Science (BS), Biology, General @ University of California, Riverside Jenni Chi is skilled in: Validation, Sop, Six Sigma, GMP, Lean Manufacturing, V&V, CAPA, Change Control, Cleaning Validation, Quality System


Jenni Chi’s Personal Email Address, Business Email, and Phone Number

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In a nutshell

Jenni Chi's Personality Type

Introversion (I), Sensing (S), Thinking (T), Perceiving (P)

Average Tenure

3 year(s), 3 month(s)

Jenni Chi's Willingness to Change Jobs

Unlikely

Likely

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