Fiscal Year

2024

Case Number

A-23135-42676

Case Status

Certified

Received Date

2023-05-26

Decision Date

2024-05-31

Refile

N

Original File Date

2024-01-01 01:32:32

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

KBI Biopharma

Employer Name Slug

kbi-biopharma

Employer Address 1

1101 Hamlin Road

Employer Address 2

Employer City

Durham

Employer City Slug

durham

Employer State

NORTH CAROLINA

Employer State Slug

north-carolina

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

27704

Employer Phone

9842272186

Employer Number of Employees

853

Employer Year Commenced Business

2000

NAICS Code

5417

FW Ownership Interest

N

Employer Contact Name

Jennifer Baker

Employer Contact Address 1

1101 Hamlin Road

Employer Contact Address 2

Employer Contact City

Durham

Employer Contact State/Province

NORTH CAROLINA KBI Biopharma

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

27704

Employer Contact Phone

9842754624

Employer Contact Email

jbaker@kbibiopharma.com

Agent Attorney Name

Derek Maka

Agent Attorney Firm Name

Ogletree, Deakins, Nash, Smoak Stewart, P.C.

Agent Attorney Phone

9197879700

Agent Attorney Address 1

One Boston Place

Agent Attorney Address 2

Suite 3500

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2108

Agent Attorney Email

derek.maka@ogletreedeakins.com

PW Track Number

P10022020840945

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

123760.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-15

PW Expiration Date

2023-06-30

Wage Offer From

139260.00

Wage Offer To

0.00

Average Salary

139260.00

Wage Unit of Pay

Year

Worksite Address 1

47 National Way

Worksite Address 2

Worksite City

Durham

Worksite City Slug

durham

Worksite State

NORTH CAROLINA

Worksite Postal Code

27703

Job Title

Senior Validation Engineer

Job Title Slug

senior-validation-engineer

Minimum Education

Master's

Major Field of Study

Chemical Engineering

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

H.11.

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

Validation Engineer, Equipment Specialist, Engineer, or related role

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Three 3 years of experience with GAMP and 21CFR Part 11 compliance requirements; Laboratory systems with computer controlled functions and cleaning and sterilization process validation; Mechanical equipment engineering and software functional testing; Applying advanced mathematical concepts such as exponents, algorithms, quadratic equations, and permutations; Regulatory guidance documents; Generating concise procedures, protocols, and summary reports; Applying sound validation principles; Kaye Validator; and Equipment control software. Two 2 years of experience with Applying mathematical operations to frequency distribution, variance analysis, and determination of reliability and validity.br br Minimum Education Experience Requirements Masters degree in Chemical Engineering, Industrial Engineering, Biomolecular Engineering, Mechanical Engineering, or related scientific field, and three 3 years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role. The employer will also accept a Bachelors degree in Chemical Engineering, Industrial Engineering, Biomolecular Engineering, Mechanical Engineering, or related scientific field, and five 5 years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role.

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

2023-01-17

SWA Job Order End Date

2023-02-20

Sunday Edition Newspaper

Y

First Newspaper Name

The News Observer

First Advertisement Start Date

2023-01-22

Second Newspaper Ad Name

The News Observer

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-01-29

Employer Website From Date

2023-01-12

Employer Website To Date

2023-02-20

Professional Organization Ad From Date

2024-01-01 01:32:32

Professional Organization Advertisement To Date

2024-01-01 01:32:32

Job Search Website From Date

2024-01-01 01:32:32

Job Search Website To Date

2024-01-01 01:32:32

Employee Referral Program From Date

2024-01-01 01:32:32

Employee Referral Program To Date

2024-01-01 01:32:32

Local Ethnic Paper From Date

2023-01-25

Local Ethnic Paper To Date

2023-01-25

Radio/TV Ad From Date

2023-01-25

Radio/TV Ad To Date

2023-01-25

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

CHEMICAL AND BIOMOLECULAR ENGINEERING

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

UNIVERSITY OF MARYLAND

Foreign Worker Education Institution Address 1

7901 REGENTS DRIVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

COLLEGE PARK

Foreign Worker Education Institution State/Province

MD

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

20742

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Derek Maka

Preparer Title

Attorney

Preparer Email

derek.maka@ogletree.com

Employer Information Declaration Name

Andrea James

Employer Information Declaration Title

HR Coordinator