Fiscal Year

2020

Case Number

A-19039-71467

Case Status

Certified-Expired

Received Date

2019-02-25

Decision Date

2019-10-21

Refile

N

Original File Date

2020-01-01 07:07:32

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

600

Employer Year Commenced Business

1992

NAICS Code

541710

FW Ownership Interest

N

Employer Contact Name

Cathleen A Mandel

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

972-948-5776

Employer Contact Email

cmandel@bluebirdbio.com

Agent Attorney Name

Rhonda Tietjen

Agent Attorney Firm Name

Ross Silverman Snyder Tietjen LLP

Agent Attorney Phone

617-542-5111

Agent Attorney Address 1

50 Congress Street

Agent Attorney Address 2

Suite 200

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2109

Agent Attorney Email

rt@rsstlawgroup.com

PW Track Number

P10018211913586

PW SOC Code

17-2112

PW SOC Title

Industrial Engineers

PW Skill Level

Level IV

PW Wage

121451.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2018-11-05

PW Expiration Date

2019-06-30

Wage Offer From

125000.00

Wage Offer To

0.00

Average Salary

125000.00

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

Manager, Process Validation

Job Title Slug

manager-process-validation

Minimum Education

Master's

Major Field of Study

Pharmaceutical Mfg, Biomedical Eng., or other technical field related to biopharma production

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

8

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Any occupation in which applicant can gain experience listed in H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

WILL CONSIDER ANY APPLICANT WITH A SUITABLE COMBINATION OF EDUCATION, TRAINING, AND EXPERIENCE.br H.10B Must have MS in pharmaceutical manufacturing, biomedical engineering, or other technical field related to biopharmaceutical production and 5 years of industry experience with clinical and commercial GMP biologics manufacturing. Experience must include working with cGMP guidelines relevant for process validation and product manufacturing; working within multiproduct facility; providing technical expertise to support manufacturing operations including interaction with CMOs; process validation experience using riskbased approach such as FMEA or PHA; project management; and experience with GMP biomanufacturing protocol development and execution; experience with interactions with health authorities and quality functions during inspections and audits; experience with developing and implementing process monitoring program; experience with single use technology including extractableleachable assessment; and direct experience working in classified GMP biomanufacturing environment. We will also accept a BS and 8 years of experience stated above.br H.12 PLEASE NOTE that the requirements bear a reasonable relationship to the occupation of Industrial Engineer, in the context of the pharmaceutical industry and are essential to perform the job in a reasonable manner. This is a Managerlevel position within our organization, and all of our Managers have at least the education and experience listed in the minimum requirements. We would not hire anyone who did not possess these credentials. This employee must have the indepth, complex, and theoretical understanding of process validation, gained through a university degree, in order to provide the level of process performance, quality control, and quality assurance support required of this position. As this employee is responsible for ensuring the success of the Process Performance Qualification campaign leading to commercial manufacture, his technical skills must be excellent. Because of the nature of this position, the advanced responsibilities it entails, the highly specialized duties specific to the tightly regulated pharmaceutical industry, and the serious consequences of any manufacturing, handling, or validation errors in the production of our pharmaceutical products, we have determined that a combination of a university education and extensive handson experience is necessary. We have determined that a Masters degree and 5 years of experience, or a Bachelors degree and 8 years of progressively responsible postdegree experience are the minimum qualifications necessary to perform this position. Please note that we have developed alternate requirements to increase our applicant pool.

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

2018-12-10

SWA Job Order End Date

2019-01-10

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2018-12-09

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2018-12-16

Employer Website From Date

2020-01-01 07:07:32

Employer Website To Date

2020-01-01 07:07:32

Professional Organization Ad From Date

2018-12-10

Professional Organization Advertisement To Date

2019-01-09

Job Search Website From Date

2018-12-10

Job Search Website To Date

2019-02-09

Employee Referral Program From Date

2020-01-01 07:07:32

Employee Referral Program To Date

2020-01-01 07:07:32

Local Ethnic Paper From Date

2020-01-01 07:07:32

Local Ethnic Paper To Date

2020-01-01 07:07:32

Radio/TV Ad From Date

2020-01-01 07:07:32

Radio/TV Ad To Date

2020-01-01 07:07:32

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

PHARMACEUTICAL MANUFACTURING

Foreign Worker Years of Education Completed

2010

Foreign Worker Institution of Education

STEVENS INSTITUTE OF TECHNOLOGY

Foreign Worker Education Institution Address 1

1 CASTLE POINT TERRACE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

HOBOKEN

Foreign Worker Education Institution State/Province

NJ

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

7030

Foreign Worker Experience with Employer

N/A

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Rhonda A Tietjen

Preparer Title

Attorney

Preparer Email

rt@rsstlawgroup.com

Employer Information Declaration Name

Erica Veilleux

Employer Information Declaration Title

HR Representative