Fiscal Year

2022

Case Number

A-21118-79357

Case Status

Certified-Expired

Received Date

2021-06-18

Decision Date

2021-11-08

Refile

N

Original File Date

2022-01-01 10:23:57

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BLUEBIRD BIO, INC.

Employer Name Slug

bluebird-bio-inc

Employer Address 1

60 BINNEY STREET

Employer Address 2

Employer City

CAMBRIDGE

Employer City Slug

cambridge

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2142

Employer Phone

6178037712

Employer Number of Employees

1090

Employer Year Commenced Business

1992

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Margaret A King

Employer Contact Address 1

60 Binney 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

617-335-9939

Employer Contact Email

mking@bluebirdbio.com

Agent Attorney Name

Irma I Dias

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

8573054467

Agent Attorney Address 1

100 High Street

Agent Attorney Address 2

3rd Floor

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2110

Agent Attorney Email

packardteam@fragomen.com

PW Track Number

P10020175675417

PW SOC Code

17-2199

PW SOC Title

Validation Engineers

PW Skill Level

Level III

PW Wage

119766.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-12-18

PW Expiration Date

2021-06-30

Wage Offer From

119800.00

Wage Offer To

0.00

Average Salary

119800.00

Wage Unit of Pay

Year

Worksite Address 1

60 Binney Street

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Computer System Validation Project Engineer

Job Title Slug

computer-system-validation-project-engineer

Minimum Education

Master's

Major Field of Study

Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Affairs, Computer Science, Pharmaceutical Sciences, or a related technical field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

Experience as a Computer System Validation CSV lead.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Experience must includebr br Three 3 years in each of the following experience may be gained concurrentlybr Working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8910, and EU Annex 11br Developing validation documentation Validation Plan, Requirements documentation, configuration specifications, IQOQPQ protocols, traceability, or reportsbr Utilizing Microsoft Word, Excel, PowerPoint, or similar applicationsbr Providing CSV guidance to a software implementation team Quality, IT CSV, IT, and Business Ownerbr br Two 2 years in the followingbr Working within a pharmaceutical Quality Management System change control, development of SOPs, or GDP including Veeva Vault QualityDocs or Veeva Vault Quality Management System QMSbr br Experience may be gained before, during, or after issuance of advanced degree.

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

2021-02-16

SWA Job Order End Date

2021-03-19

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-03-07

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-14

Employer Website From Date

2022-01-01 10:23:57

Employer Website To Date

2022-01-01 10:23:57

Professional Organization Ad From Date

2022-01-01 10:23:57

Professional Organization Advertisement To Date

2022-01-01 10:23:57

Job Search Website From Date

2021-03-12

Job Search Website To Date

2021-03-25

Employee Referral Program From Date

2021-02-09

Employee Referral Program To Date

2021-03-09

Local Ethnic Paper From Date

2022-01-01 10:23:57

Local Ethnic Paper To Date

2022-01-01 10:23:57

Radio/TV Ad From Date

2022-01-01 10:23:57

Radio/TV Ad To Date

2022-01-01 10:23:57

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

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Irma I Dias

Preparer Title

Attorney

Preparer Email

packardteam@fragomen.com

Employer Information Declaration Name

Maggie King

Employer Information Declaration Title

Senior Global Mobility Specialist