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Case Number: A-22129-52139

Fiscal year: 2023

Fiscal Year

2023

Case Number

A-22129-52139

Case Status

Certified

Received Date

2022-06-09

Decision Date

2023-02-13

Refile

N

Original File Date

2023-01-01 08:07:37

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Arranta Bio MA LLC

Employer Name Slug

arranta-bio-ma-llc

Employer Address 1

650 Pleasant Street

Employer Address 2

Employer City

Watertown

Employer City Slug

watertown

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2472

Employer Phone

(631) 449-8086

Employer Number of Employees

160

Employer Year Commenced Business

2019

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Ashley Spangler

Employer Contact Address 1

650 Pleasant Street

Employer Contact Address 2

Employer Contact City

Watertown

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2472

Employer Contact Phone

(631) 449-8086

Employer Contact Email

ashley.spangler@arrantabio.com

Agent Attorney Name

Rhonda A 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

P10021120276780

PW SOC Code

17-2199

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

162032.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-01-12

PW Expiration Date

2022-06-30

Wage Offer From

171700.00

Wage Offer To

0.00

Average Salary

171700.00

Wage Unit of Pay

Year

Worksite Address 1

650 Pleasant Street

Worksite Address 2

Suite 230

Worksite City

Watertown

Worksite City Slug

watertown

Worksite State

MASSACHUSETTS

Worksite Postal Code

2472

Job Title

Senior Validation Manager

Job Title Slug

senior-validation-manager

Minimum Education

Bachelor's

Major Field of Study

Pharmaceutical Engineering, Biochemical Engineering, or related field

Required Training

N

Required Experience

Y

Required Experience Months

96

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

Any occupation that gains experience required 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 OR EXPERIENCEbr br H.10B Must have BS in pharmaceutical engineering, biochemical engineering, or related field and 8 years of experience in latephase or commercial biotechnology GMP manufacturing operations including experience in the following cell culture or fermentation, purification, and lyophilization; working with FDA regulations 21 CFR part 11, 210, 211, 600 and corresponding EU regulations; working with ICH Q7 Q8, Q9, Q10 and other international regulatory requirements; preparing and following through on contingency plans; and managing a Site Validation Master plan and deliverables. We will also accept an MS degree and 5 years of experience.br br H.12 PLEASE NOTE that the requirements bear a reasonable relationship to the occupation of Validation Engineer, in the context of the pharmaceutical industry and are essential to perform the job in a reasonable manner. This is a Senior Validation Manager position all of our Sr Managers have at least the education and experience listed in the minimum requirements, and we would not hire anyone who did not possess these credentials. PLEASE NOTE that these requirements are consistent with our job ladder, as Validation Engineers require BS3 or MS1; Sr. Validation Engineers require BS5 or MS3; and Sr. Validation Managers require BS8 or MA 5. 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 providing leadership to manage the site validation of equipment, utilities, computer systems, cleaning, and processes, 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

2022-03-18

SWA Job Order End Date

2022-04-18

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2022-02-13

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-02-20

Employer Website From Date

2022-02-14

Employer Website To Date

2022-02-25

Professional Organization Ad From Date

2023-01-01 08:07:37

Professional Organization Advertisement To Date

2023-01-01 08:07:37

Job Search Website From Date

2022-02-08

Job Search Website To Date

2022-03-08

Employee Referral Program From Date

2023-01-01 08:07:37

Employee Referral Program To Date

2023-01-01 08:07:37

Local Ethnic Paper From Date

2023-01-01 08:07:37

Local Ethnic Paper To Date

2023-01-01 08:07:37

Radio/TV Ad From Date

2023-01-01 08:07:37

Radio/TV Ad To Date

2023-01-01 08:07:37

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 ENGINEERING

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

Ashley Spangler

Employer Information Declaration Title

Talent Engagement Manager