Prevailing Wage SOC Title :Validation Engineers 172199.02
Prevailing Wage Skill Level:Level IV
Prevailing Wage:130894
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-05-06
Prevailing Wage Expiration Date :2021-08-04
Wage Offer From:130894
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:800 Dwight Way
Worksite Address Line 2:
Worksite City :Berkeley
Worksite State:CALIFORNIA
Worksite Postal Code:94710
Job Title:Specialist Instrumentation Quality and Software Validation
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Chemical Engineering, Life Sciences or Related Field
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:36
Accept Alternate Job Title:Related pharmaceutical industry position.
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:Experience must include two 2 years performing analytical computerized instrument and software validation.br br Must also have any experience with or knowledge of i national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity; ii cGMP, FDA 21 CFR Part 11210211, EU Annex 11, MHRA guidelines; iii risk assessment, gap analysis, change control; and deviation management; iv CDS Chromeleon, Empower, Agilent ECM administration, SDMS Nugenesis, ECM; v working with databases, e.g., SQL Server, Oracle, and data from multiple CSVs; vi qualification of various Analytical Laboratory InstrumentsSoftware, including HPLCs, UPLCs, GCs, Potency Analyzers, Empower, Omnic software, Spreadsheets with a focus on data integrity; vii change control, deviation investigations, and CAPA to ensure compliance; and viii supporting laboratories by writing administration SOPs and acting as an administrator for various software.br br Experience can be concurrent.br br Note Since there is no experience required in H.6, the Kellogg language is not required.
Combination Occupation :N
Offered to Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-07-13
Job Oder End Date:2021-08-16
Sunday Edition Newspaper:Y
First Newspaper Name:San Francisco Chronicle
First Advertisement Start Date:2021-07-18
Second Newspaper Name:San Francisco Chronicle
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-07-25
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-07-13
Employer Website to Date:2021-10-14
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-07-18
Job Search Website to Date:2021-07-30
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-07-22
Local Ethnic Newspaper to Date:2021-07-22
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:CHEMICAL ENGINEERING
Year of Compelted Education:2015
Foreign Worker Istitution of Eduation:LAMAR UNIVERSITY
Foreign Worker Education Instution Address Line 1:4400 S M L KING JR PARKWAY
Foreign Worker Education Institution Address Line 2: