Fiscal Year

2024

Case Number

A-23011-85917

Case Status

Certified-Expired

Received Date

2023-02-14

Decision Date

2024-03-14

Refile

N

Original File Date

2024-01-01 00:57:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Novel Laboratories Inc.

Employer Name Slug

novel-laboratories-inc

Employer Address 1

400 Campus Drive

Employer Address 2

Employer City

Somerset

Employer City Slug

somerset

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8873

Employer Phone

9086036000

Employer Number of Employees

228

Employer Year Commenced Business

2007

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Prakash Salunke

Employer Contact Address 1

400 Campus Drive

Employer Contact Address 2

Employer Contact City

Somerset

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

8873

Employer Contact Phone

9086036000 6063

Employer Contact Email

prakashsalunke@lupin.com

Agent Attorney Name

Erin Hogan

Agent Attorney Firm Name

Quarles Brady LLP

Agent Attorney Phone

3127155248

Agent Attorney Address 1

300 N. LaSalle Street

Agent Attorney Address 2

Suite 4000

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60654

Agent Attorney Email

Erin.Hogan@quarles.com

PW Track Number

P10022137177987

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

119829.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-19

PW Expiration Date

2023-06-30

Wage Offer From

119829.00

Wage Offer To

0.00

Average Salary

119829.00

Wage Unit of Pay

Year

Worksite Address 1

400 Campus Drive

Worksite Address 2

Worksite City

Somerset

Worksite City Slug

somerset

Worksite State

NEW JERSEY

Worksite Postal Code

8873

Job Title

Computer Systems Validation Engineer

Job Title Slug

computer-systems-validation-engineer

Minimum Education

Master's

Major Field of Study

Chemical Engineering, Pharmaceutical Engineering, or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Chemical Engineering, Pharmaceutical Engineering, or a related 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

24

Accept Alternative Job Title

validation engineering

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Chemical Engineering, Pharmaceutical Engineering, or a related field plus two years or Bachelors degree plus five progressive years of validation engineering experience. Must have at least two years of experience in each of the following 1. Utilizing and applying chemical engineeringpharmaceutical engineering principles in validating Supervisory Control and Data Acquisition SCADA, and Human Machine Interface HMIs for pharmaceutical manufacturing processes; 2. Ensuring manufacturing compliance with FDA regulations, including 21 CFR Parts 11, and 21 CFR Part 210211; 3. Developing and reviewing Process Flow Diagrams, PIDs, system manuals, equipment specifications, and technical reports; 4. Writing and executing validationqualification protocols and analyze critical process parameters and critical quality attributes for Fluid Bed Dryer, Tablet Compression Machines, and Tablet Hardness testers; 5. Generating and executing computer systems validation protocols for production equipment in an FDA regulated environment; 6. Participating in the commissioning, qualification, and validation of Total Organic Content Analyzers, HVAC and Building Automation System, Packaging Lines, Controls and Automation, and Process Equipment; and 7. Being responsible for ensuring data integrity of the laboratory systems including High Pressure Liquid Chromatography, Ultra Performance Liquid Chromatography, UVVis, Particle Size Analyzer, Refractometer, Polarimeter, and Fourier Transformed Infrared Spectroscopy. Will accept any suitable combination of education, training, or experience.

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

2022-09-09

SWA Job Order End Date

2022-10-17

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2022-09-18

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-09-25

Employer Website From Date

2022-09-19

Employer Website To Date

2022-09-30

Professional Organization Ad From Date

2024-01-01 00:57:19

Professional Organization Advertisement To Date

2024-01-01 00:57:19

Job Search Website From Date

2024-01-01 00:57:19

Job Search Website To Date

2024-01-01 00:57:19

Employee Referral Program From Date

2024-01-01 00:57:19

Employee Referral Program To Date

2024-01-01 00:57:19

Local Ethnic Paper From Date

2022-09-21

Local Ethnic Paper To Date

2022-09-21

Radio/TV Ad From Date

2022-10-01

Radio/TV Ad To Date

2022-10-01

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 ENGINEERING

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

LAMAR UNIVERSITY

Foreign Worker Education Institution Address 1

4400 S M L KING JR PKWY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BEAUMONT

Foreign Worker Education Institution State/Province

TX

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

77705

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Erin Hogan

Preparer Title

Attorney

Preparer Email

erin.hogan@quarles.com

Employer Information Declaration Name

Prakash Salunke

Employer Information Declaration Title

Director HR