Fiscal Year

2020

Case Number

A-19340-91705

Case Status

Certified

Received Date

2019-12-06

Decision Date

2020-04-24

Refile

N

Original File Date

2020-01-01 08:22:34

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SHIRE PHARMACEUTICALS LLC

Employer Name Slug

shire-pharmaceuticals-llc

Employer Address 1

300 SHIRE WAY

Employer Address 2

Employer City

LEXINGTON

Employer City Slug

lexington

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2421

Employer Phone

617-588-8356

Employer Number of Employees

49578

Employer Year Commenced Business

2004

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Paul Lambert

Employer Contact Address 1

650 East Kendall Street

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

617-588-8655

Employer Contact Email

paul.lambert@shire.com

Agent Attorney Name

Jennifer A Hoskin

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2132

Agent Attorney Address 1

135 S LaSalle Street

Agent Attorney Address 2

3425

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

jhoskin@zulkiepartners.com

PW Track Number

P10018348674193

PW SOC Code

17-2199

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

124904.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-04-23

PW Expiration Date

2019-07-22

Wage Offer From

125000.00

Wage Offer To

138100.00

Average Salary

131550.00

Wage Unit of Pay

Year

Worksite Address 1

500 Shire Way

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Computer System Validation Analyst

Job Title Slug

computer-system-validation-analyst

Minimum Education

Bachelor's

Major Field of Study

ENGINEERING, SCIENCE, OR A RELATED FIELD

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

60

Accept Alternative Job Title

BIOMEDICAL SYSTEMS VALIDATION ENGINEER OR RELATED POSITION

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

WILL ACCEPT ANY LEVEL OF EXPERIENCE IN THE FOLLOWING SKILLS INTERPRET AND APPLY PRODUCT SPECIFICATIONS, TECHNICAL DATA, POLICY STATEMENTS, REGULATIONS INCLUDING SDLC, 21 CFR PART 11, ANNEX 11, GXP, CSV, USP 1058 FOR VALIDATION OF COMPUTERIZED AND LABORATORY SYSTEMS IN REGULATED ENVIRONMENT; PROVIDE COMPLIANCE OVERSIGHT THROUGH PROJECT LIFECYCLE, INCLUDING DESIGN, DEVELOPMENT, IMPLEMENTATION, SUPPORT AND ENHANCEMENT PHASES; PERFORM RISK ASSESSMENTS TO DETERMINE TESTING SCOPE, DEFECT ROOT CAUSE ANALYSIS AND RISK MANAGEMENT FOR GXP SYSTEMS; ASSESS QUALITY SYSTEM ELEMENTS FOR VALIDATION INCLUDING CAPAS, CHANGE CONTROLS, DEVIATIONS, AND GMP INVESTIGATIONS.

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

2019-06-24

SWA Job Order End Date

2019-07-26

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2019-06-30

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-07-07

Employer Website From Date

2019-06-24

Employer Website To Date

2019-07-30

Professional Organization Ad From Date

2020-01-01 08:22:34

Professional Organization Advertisement To Date

2020-01-01 08:22:34

Job Search Website From Date

2019-06-30

Job Search Website To Date

2019-07-14

Employee Referral Program From Date

2020-01-01 08:22:34

Employee Referral Program To Date

2020-01-01 08:22:34

Local Ethnic Paper From Date

2019-07-01

Local Ethnic Paper To Date

2019-07-01

Radio/TV Ad From Date

2020-01-01 08:22:34

Radio/TV Ad To Date

2020-01-01 08:22:34

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

Bachelor's

Foreign Worker Information: Major

ENGINEERING

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

VISVESWARAIAH TECHNOLOGICAL UNIVERSITY, BELGAUM

Foreign Worker Education Institution Address 1

SHAVIGE MALLESHWARA HILLS, KUMARASWAMY LAYOUT

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BANGALORE

Foreign Worker Education Institution State/Province

KARNATAKA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

560078

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Jennifer A Hoskin

Preparer Title

Associate

Preparer Email

jhoskin@zulkiepartners.com

Employer Information Declaration Name

Paul Lambert

Employer Information Declaration Title

Global Mobility Manager