Fiscal Year

2022

Case Number

A-21012-41229

Case Status

Denied

Received Date

2020-12-30

Decision Date

2022-04-28

Refile

N

Original File Date

2022-01-01 11:21:45

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

HALO PHARMACEUTICAL, INC. DBA CAMBREX WHIPPANY

Employer Name Slug

halo-pharmaceutical-inc-dba-cambrex-whippany

Employer Address 1

30 NORTH JEFFERSON ROAD

Employer Address 2

Employer City

WHIPPANY

Employer City Slug

whippany

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7981

Employer Phone

(973) 428-4378

Employer Number of Employees

250

Employer Year Commenced Business

2006

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

ANITA HOCKWITT

Employer Contact Address 1

30 NORTH JEFFERSON RD

Employer Contact Address 2

Employer Contact City

WHIPPANY

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7981

Employer Contact Phone

(973) 428-4342

Employer Contact Email

ANITA.HOCKWITT@CAMBREX.COM

Agent Attorney Name

SHIRLEY TANG

Agent Attorney Firm Name

COHEN TAUBER SPIEVACK WAGNER P.C.

Agent Attorney Phone

(917) 338-7624

Agent Attorney Address 1

420 LEXINGTON AVENUE

Agent Attorney Address 2

SUITE 2400

Agent Attorney City

NEW YORK

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10170

Agent Attorney Email

STANG@CTSWLAW.COM

PW Track Number

P10020177679280

PW SOC Code

17-2199

PW SOC Title

VALIDATION ENGINEERS

PW Skill Level

Level III

PW Wage

147035.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-10-27

PW Expiration Date

2021-06-30

Wage Offer From

147035.00

Wage Offer To

0.00

Average Salary

147035.00

Wage Unit of Pay

Year

Worksite Address 1

30 N. JEFFERSON ROAD

Worksite Address 2

Worksite City

WHIPPANY

Worksite City Slug

whippany

Worksite State

NEW JERSEY

Worksite Postal Code

7981

Job Title

VALIDATION SPECIALIST

Job Title Slug

validation-specialist

Minimum Education

Master's

Major Field of Study

PHARMACEUTICAL ENGINEERING, PHARMACEUTICAL MANUFACTURING OR RELATED ENGINEERING FIELD.

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

PHARMACEUTICAL ENGINEERING, PHARMACEUTICAL MANUFACTURING OR RELATED ENGINEERING 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

36

Accept Alternative Job Title

HANDSON VALIDATION ROLE IN THE PHARMACEUTICAL ANDOR HOUSEHOLDCONSUMER PRODUCTS INDUSTRY

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

MUST HAVE KNOWLEDGE OFbr br .EQUIPMENT, UTILITY QUALIFICATION AND CALIBRATIONbr .FAT, URS, SAT COMMISSIONING ACTIVITIESbr .PROCESS VALIDATIONbr .CLEANING VALIDATIONbr .CLEAN IN PLACE CIP, CLEAN OUT PLACE COPbr .STERILE MANUFACTURING AND PERFORM QUALIFICATION FOR STERILE MANUFACTING SYSTEMSbr .DEVELOPING SOP, VMP,VPP, IOPQ PROTOCOLSbr .PERFORMING RISK ASSESSMEMT, CAPA INVESTIGATIONbr .PERFORMING STATISTICAL ANALYSIS USING MINITAB SOFTWAREbr br ALTERNATIVELY, THE EMPLOYER WILL ACCEPT A BS OR EQUIVALENT IN THE ABOVE FIELDS OF STUDY AND 5 YEARS OF EXPERIENCE IN THE JOB OFFERED OR IN A HANDS0N VALLDATLON ROLE.br br ADDITIONAL INFORMATION FROM SECTION K. JOB 2, ITEM 9br br PERFORMED CALIBRATION OF DIFFERENT EQUIPMENT AND KEEP TRACK OF CALIBRATION REPORTS; DEVELOPED AND REVIEWED SOP, CHANGE CONTROL DOCUMENT, CAPA; VALIDATED DIFFERENT EQUIPMENT LIKE SURGE TANK, POT WASHER, MELTING AND HOLDING SKID, PREMIX SKID, STORAGE TANK, FIBERGLASS TANK, FINISHING LINES, STEAM TUNNEL, BOILER, LABELER APPLICATOR, ETC; AND VALIDATED CRITICAL UTILITY LIKE WATER SYSTEM, ETC.br DURING HIS EMPLOYMENT, MR. SHAH UTILIZED AND APPLIED HIS KNOWLEDGE OF THE FOLLOWING PROTOCOLS AND SKILLSbr br EQUIPMENT, UTILITY QUALIFICATION AND CALIBRATIONbr FAT, URS, SAT, COMMISSIONING ACTIVITIESbr PROCESS VALIDATIONbr CLEANING VALIDATIONbr CLEAN IN PLACE CIP, CLEAN OUT PLACE COPbr STERILE MANUFACTURING AND PERFORM QUALIFICATION FOR THE STERILE MANUFACTURING SYSTEMS.br DEVELOPING SOP, VMP, VPP, IOPQ PROTOCOLSbr PERFORMING RISK ASSESSMENT, CAPA INVESTIGATIONbr PERFORMING STATISTICAL ANALYSIS USING MINITAB SOFTWAREbr br SUPERVISOR TRUSH AGRAWALbr PHONE# 812 7504300

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

2020-06-29

SWA Job Order End Date

2020-08-01

Sunday Edition Newspaper

Y

First Newspaper Name

THE STAR LEDGER

First Advertisement Start Date

2020-07-19

Second Newspaper Ad Name

THE STAR LEDGER

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-26

Employer Website From Date

2020-06-29

Employer Website To Date

2020-07-13

Professional Organization Ad From Date

2022-01-01 11:21:45

Professional Organization Advertisement To Date

2022-01-01 11:21:45

Job Search Website From Date

2020-07-17

Job Search Website To Date

2020-07-30

Employee Referral Program From Date

2022-01-01 11:21:45

Employee Referral Program To Date

2022-01-01 11:21:45

Local Ethnic Paper From Date

2020-09-03

Local Ethnic Paper To Date

2020-09-03

Radio/TV Ad From Date

2022-01-01 11:21:45

Radio/TV Ad To Date

2022-01-01 11:21:45

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

2012

Foreign Worker Institution of Education

STEVENS INSTITUTE OF TECHNOLOGY

Foreign Worker Education Institution Address 1

CASTLE POINT ON HUDSON

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

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

SHIRLEY TANG

Preparer Title

LAWYER

Preparer Email

STANG@CTSWLAW.COM

Employer Information Declaration Name

ANITA HOCKWITT

Employer Information Declaration Title

HR MANAGER