Fiscal Year

2021

Case Number

A-20112-45344

Case Status

Certified-Expired

Received Date

2020-06-18

Decision Date

2020-12-22

Refile

N

Original File Date

2021-01-01 08:55:47

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

COVANCE, INC.

Employer Name Slug

covance-inc

Employer Address 1

206 CARNEGIE CENTER

Employer Address 2

Employer City

PRINCETON

Employer City Slug

princeton

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8540

Employer Phone

609-452-4550

Employer Number of Employees

21247

Employer Year Commenced Business

1997

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Irina Bobrovnikov

Employer Contact Address 1

10 Moore Drive

Employer Contact Address 2

Employer Contact City

Durham

Employer Contact State/Province

NORTH CAROLINA NC

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

27709

Employer Contact Phone

9842452447

Employer Contact Email

US&CanadaImmigration@Covance.com

Agent Attorney Name

Joshua S Mirer

Agent Attorney Firm Name

Robinson Cole LLP

Agent Attorney Phone

8602758344

Agent Attorney Address 1

280 Trumbull Street, Floor 28

Agent Attorney Address 2

Agent Attorney City

Hartford

Agent Attorney State/Province

CONNECTICUT

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

6103

Agent Attorney Email

jmirer@rc.com

PW Track Number

P10020080422955

PW SOC Code

15-1199

PW SOC Title

Software Quality Assurance Engineers and Testers

PW Skill Level

Level IV

PW Wage

94598.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-06-16

PW Expiration Date

2020-09-14

Wage Offer From

113110.00

Wage Offer To

0.00

Average Salary

113110.00

Wage Unit of Pay

Year

Worksite Address 1

8211 SciCor Drive

Worksite Address 2

Worksite City

Indianapolis

Worksite City Slug

indianapolis

Worksite State

INDIANA

Worksite Postal Code

46214

Job Title

Validation Engineer III

Job Title Slug

validation-engineer-iii

Minimum Education

Bachelor's

Major Field of Study

Life Science

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmaceutics, Operations Research, Technology or a related field.

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

Progressive experience in the Business, Validation and Regulatory field.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must possess the following at least 5 years of experience with FDA and 21 CFR Part 11 Electronic Records, Electronic Signatures regulations and how they apply to software validation; at least 5 years of experience with regulatory compliance requirements in the pharmaceutical and drug development industry GXPs; at least 5 years of experience working within and maintaining risk based methodologies; at least 4 years of experience with associated validation concepts and governing industry standards 21 CFR Part 11, GAMP HIPAA, ISO9000; at least 4 years of experience of Clinical Trial Operational Processes, Biochemical concepts and Terminology for Clinical Trial Applications; at least 4 years of experience in validating COTS, custom COTS, inhouse developed, and Xaas systems; at least 4 years of experience with traditional waterfall model and iterativeagile development methodologies and experience with business process modeling and requirements management tools Jama, JIRA, Visio, HP ALM, and TopTeam; at least 4 years of experience with various validation methodologies SDLC, and their implementation; at least 3 years of experience in Clinical Labs, FDA GXP regulated industry such as pharmaceutical, CRO, medical device, biotechnology or related industry; and at least 2 years of experience in formally documenting business requirements.

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

2020-03-20

SWA Job Order End Date

2020-04-24

Sunday Edition Newspaper

Y

First Newspaper Name

Indianapolis Star

First Advertisement Start Date

2020-04-19

Second Newspaper Ad Name

Indianapolis Star

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-05-10

Employer Website From Date

2021-01-01 08:55:47

Employer Website To Date

2021-01-01 08:55:47

Professional Organization Ad From Date

2020-04-17

Professional Organization Advertisement To Date

2020-04-17

Job Search Website From Date

2020-04-08

Job Search Website To Date

2020-04-22

Employee Referral Program From Date

2021-01-01 08:55:47

Employee Referral Program To Date

2021-01-01 08:55:47

Local Ethnic Paper From Date

2021-01-01 08:55:47

Local Ethnic Paper To Date

2021-01-01 08:55:47

Radio/TV Ad From Date

2020-04-15

Radio/TV Ad To Date

2020-04-15

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

BIOCHEMISTRY

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

UNIVERSITY OF SCRANTON

Foreign Worker Education Institution Address 1

800 LINDEN STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

SCRANTON

Foreign Worker Education Institution State/Province

PA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

18510

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Joshua S Mirer

Preparer Title

Attorney

Preparer Email

jmirer@rc.com

Employer Information Declaration Name

Irina Bobrovnikov

Employer Information Declaration Title

Associate Dir, Global Immigration Global Mobility