Fiscal Year

2023

Case Number

A-23055-05665

Case Status

Withdrawn

Received Date

2023-02-24

Decision Date

2023-03-10

Refile

N

Original File Date

2023-01-01 08:01:36

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Rani Therapeutics, LLC

Employer Name Slug

rani-therapeutics-llc

Employer Address 1

2051 Ringwood Ave

Employer Address 2

Employer City

San Jose

Employer City Slug

san-jose

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

95131

Employer Phone

4084573701

Employer Number of Employees

166

Employer Year Commenced Business

2012

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Bella Vazquez

Employer Contact Address 1

2051 Ringwood Ave

Employer Contact Address 2

Employer Contact City

San Jose

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

95131

Employer Contact Phone

408-457-3701

Employer Contact Email

bella@ranitherapeutics.com

Agent Attorney Name

Nicole A Tahtouh

Agent Attorney Firm Name

JEWELL STEWART PRATT PC

Agent Attorney Phone

415 434-1161

Agent Attorney Address 1

456 Montgomery Street

Agent Attorney Address 2

Flr 19

Agent Attorney City

San Francisco

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94104

Agent Attorney Email

nicole@jspvisa.com

PW Track Number

P10022092031606

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

Level III

PW Wage

122408.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-02-02

PW Expiration Date

2023-06-30

Wage Offer From

122408.00

Wage Offer To

140000.00

Average Salary

131204.00

Wage Unit of Pay

Year

Worksite Address 1

2051 Ringwood Ave

Worksite Address 2

Worksite City

San Jose

Worksite City Slug

san-jose

Worksite State

CALIFORNIA

Worksite Postal Code

95131

Job Title

Quality Assurance Engineer

Job Title Slug

quality-assurance-engineer

Minimum Education

Master's

Major Field of Study

Biomedical Engineering, Chemical Engineering, Chemistry, or related.

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

See H.14.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

From Section C. 19 Rani Therapeutics, LLC FEIN 611677171 is the Employer, and successor in interest to Rani Management Services, Inc FEIN 843605036, a wholly owned subsidiary of Rani Therapeutics, LLC. Note, the beneficiary was moved to Rani Therapeutics, LLC payroll in October 2022. As the successor in interest of Rani Management Services, Inc, Rani Therapeutics, LLC conducted all recruitment efforts under the name of Rani Therapeutics, LLC also known as Rani, as permitted under the regulations.br br Note to clarify Boxes F.2. and F.3. Prevailing Wage Information The SOCONET code assigned by the Department of Labor in the prevailing wage determination is 172112, Industrial Engineers. The determination included an additional note stating the six digit SOC code is assigned with the extension 172112.02 Validation Engineers.br br From H.10B. Identify the job title of the acceptable alternate occupation quality assurance andor engineering experience in the medical device, biopharmaceutical, andor pharmaceutical industry.br br Experience above must include 3 years with the NCMR Process to investigate and resolve nonconformances for Device Design, Device Process and Materials, and supplier nonconformance SCAR. Background owning CAPA investigations, identifying root cause, and implementing corrective actions. Experience above must include 3 years authoring technical documents, including Master Validation Plan MVP, IQ, OQ, and PQ protocols and reports. Experience above must include 3 years performing and approving Test Method Validation TMV. Knowledge of Design Control activities, including Verification and Validation, in accordance with 21 CFR Part 820. Understanding of statistical techniques for data analysis, including Statistical Process Control SPC and Design of Experiment DOE. Experience above must include 3 years developing and implementing statistical sampling plans. Background developing or approving risk management documents in accordance with ISO 14971, including Risk Management Plan, DFMEA, and PFMEA. Background reviewing and approving Manufacturing Process Instructions MPIs, Lot History Records LHRs, components and assembly drawings specifications. Background reviewing and approving protocols for the Installation, Operation, and Performance Qualification of equipment used for manufacturing and bioanalysis. Experience above must include 3 years reviewing and approving Engineering Change Controls through the ECO process.br br None of these skills can be acquired in a reasonable period of onthejob training.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2022-09-20

SWA Job Order End Date

2022-10-25

Sunday Edition Newspaper

Y

First Newspaper Name

The Mercury News

First Advertisement Start Date

2022-09-25

Second Newspaper Ad Name

The Mercury News

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-02

Employer Website From Date

2022-09-22

Employer Website To Date

2022-09-29

Professional Organization Ad From Date

2023-01-01 08:01:36

Professional Organization Advertisement To Date

2023-01-01 08:01:36

Job Search Website From Date

2022-09-22

Job Search Website To Date

2022-09-29

Employee Referral Program From Date

2023-01-01 08:01:36

Employee Referral Program To Date

2023-01-01 08:01:36

Local Ethnic Paper From Date

2023-01-01 08:01:36

Local Ethnic Paper To Date

2023-01-01 08:01:36

Radio/TV Ad From Date

2023-01-01 08:01:36

Radio/TV Ad To Date

2023-01-01 08:01:36

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

CHEMISTRY

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

CLEVELAND STATE UNIVERSITY

Foreign Worker Education Institution Address 1

2121 EUCLID AVE.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CLEVELAND

Foreign Worker Education Institution State/Province

OH

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

44115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Nicole A Tahtouh

Preparer Title

Associate Attorney

Preparer Email

nicole@jspvisa.com

Employer Information Declaration Name

Bella Vazquez

Employer Information Declaration Title

Vice President of Human Resources