Fiscal Year

2024

Case Number

A-22356-78175

Case Status

Certified-Expired

Received Date

2023-01-03

Decision Date

2024-01-31

Refile

N

Original File Date

2024-01-01 00:38:43

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

NorthStar Medical Radioisotopes, LLC

Employer Name Slug

northstar-medical-radioisotopes-llc

Employer Address 1

1800 Gateway Blvd

Employer Address 2

Employer City

Beloit

Employer City Slug

beloit

Employer State

WISCONSIN

Employer State Slug

wisconsin

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

53511

Employer Phone

6083138000

Employer Number of Employees

300

Employer Year Commenced Business

2007

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Adrienne Carney

Employer Contact Address 1

1800 Gateway Blvd

Employer Contact Address 2

Employer Contact City

Beloit

Employer Contact State/Province

WISCONSIN

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

53511

Employer Contact Phone

6083138113

Employer Contact Email

acarney@northstarnm.com

Agent Attorney Name

Melina Villalobos

Agent Attorney Firm Name

Ogletree, Deakins, Nash, Smoak Stewart, P.C.

Agent Attorney Phone

919-789-3241

Agent Attorney Address 1

8529 Six Forks Road

Agent Attorney Address 2

Forum IV, Suite 600

Agent Attorney City

Raleigh

Agent Attorney State/Province

NORTH CAROLINA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

27615

Agent Attorney Email

melina.villalobos@ogletreedeakins.com

PW Track Number

P10022158253134

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

90667.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-20

PW Expiration Date

2023-06-30

Wage Offer From

107000.00

Wage Offer To

120000.00

Average Salary

113500.00

Wage Unit of Pay

Year

Worksite Address 1

1800 Gateway Blvd

Worksite Address 2

Worksite City

Beloit

Worksite City Slug

beloit

Worksite State

WISCONSIN

Worksite Postal Code

53511

Job Title

Senior Validation Engineer

Job Title Slug

senior-validation-engineer

Minimum Education

Bachelor's

Major Field of Study

Science

Required Training

N

Required Experience

Y

Required Experience Months

72

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Engineering any, or related field of study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

4

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

72

Accept Alternative Job Title

In the job offered or related occupation.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Applicants must have demonstrated experience withbr br Pharmaceutical industry in a Qualification or Validation role;br Working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment;br Statistical Analysis;br 21 CFR Part 11, 21 CFR Part 210 and 21 CFR Part 211;br Computer System Validation, EquipmentInstrumentUtility Qualification and Process Validation;br RiskBased Approach to commissioning and qualification such as ISPE and GAMP 5;br Waterfall model and VModel;br Executing protocols using automated test management tools such as HP ALMApplication Lifecycle Management;br Performing Risk Assessments, Data Integrity Assessments, and Gap Assessments.

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

2022-10-24

SWA Job Order End Date

2022-11-28

Sunday Edition Newspaper

Y

First Newspaper Name

Wisconsin State Journal

First Advertisement Start Date

2022-10-30

Second Newspaper Ad Name

Wisconsin State Journal

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-11-06

Employer Website From Date

2024-01-01 00:38:43

Employer Website To Date

2024-01-01 00:38:43

Professional Organization Ad From Date

2024-01-01 00:38:43

Professional Organization Advertisement To Date

2024-01-01 00:38:43

Job Search Website From Date

2022-10-30

Job Search Website To Date

2022-11-13

Employee Referral Program From Date

2024-01-01 00:38:43

Employee Referral Program To Date

2024-01-01 00:38:43

Local Ethnic Paper From Date

2022-11-02

Local Ethnic Paper To Date

2022-11-02

Radio/TV Ad From Date

2022-11-03

Radio/TV Ad To Date

2022-11-03

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

CHEMICAL ENGINEERING

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

THE UNIVERSITY OF DAYTON

Foreign Worker Education Institution Address 1

300 COLLEGE PARK

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

DAYTON

Foreign Worker Education Institution State/Province

OH

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

45469

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Melina Villalobos

Preparer Title

Attorney

Preparer Email

melina.villalobos@ogletreedeakins.com

Employer Information Declaration Name

Adrienne Carney

Employer Information Declaration Title

Manager, Human Resources