Major Field of Study:Biomedical Engineering, Chemical Engineering, Chemistry, or related.
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:See H.14.
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:From Section C. 19 Rani Therapeutics, LLC FEIN 611677171 is the Employer, and successor in interest to Rani Management Services, Inc FEIN 843605036, a wholly owned subsidiary of Rani Therapeutics, LLC. Note, the beneficiary was moved to Rani Therapeutics, LLC payroll in October 2022. As the successor in interest of Rani Management Services, Inc, Rani Therapeutics, LLC conducted all recruitment efforts under the name of Rani Therapeutics, LLC also known as Rani, as permitted under the regulations.br br Note to clarify Boxes F.2. and F.3. Prevailing Wage Information The SOCONET code assigned by the Department of Labor in the prevailing wage determination is 172112, Industrial Engineers. The determination included an additional note stating the six digit SOC code is assigned with the extension 172112.02 Validation Engineers.br br From H.10B. Identify the job title of the acceptable alternate occupation quality assurance andor engineering experience in the medical device, biopharmaceutical, andor pharmaceutical industry.br br Experience above must include 3 years with the NCMR Process to investigate and resolve nonconformances for Device Design, Device Process and Materials, and supplier nonconformance SCAR. Background owning CAPA investigations, identifying root cause, and implementing corrective actions. Experience above must include 3 years authoring technical documents, including Master Validation Plan MVP, IQ, OQ, and PQ protocols and reports. Experience above must include 3 years performing and approving Test Method Validation TMV. Knowledge of Design Control activities, including Verification and Validation, in accordance with 21 CFR Part 820. Understanding of statistical techniques for data analysis, including Statistical Process Control SPC and Design of Experiment DOE. Experience above must include 3 years developing and implementing statistical sampling plans. Background developing or approving risk management documents in accordance with ISO 14971, including Risk Management Plan, DFMEA, and PFMEA. Background reviewing and approving Manufacturing Process Instructions MPIs, Lot History Records LHRs, components and assembly drawings specifications. Background reviewing and approving protocols for the Installation, Operation, and Performance Qualification of equipment used for manufacturing and bioanalysis. Experience above must include 3 years reviewing and approving Engineering Change Controls through the ECO process.br br None of these skills can be acquired in a reasonable period of onthejob training.
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:2022-09-20
Job Oder End Date:2022-10-25
Sunday Edition Newspaper:Y
First Newspaper Name:The Mercury News
First Advertisement Start Date:2022-09-25
Second Newspaper Name:The Mercury News
Second Advertisement Type:Newspaper
Second Ad Start Date:2022-10-02
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2022-09-22
Employer Website to Date:2022-09-29
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2022-09-22
Job Search Website to Date:2022-09-29
Private Employment Firm from Date:2022-09-12
Pricate Employment Firm to Date:2022-10-03
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:
Local Ethnic Newspaper to Date:
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:CHEMISTRY
Year of Compelted Education:2014
Foreign Worker Istitution of Eduation:CLEVELAND STATE UNIVERSITY
Foreign Worker Education Instution Address Line 1:2121 EUCLID AVE.
Foreign Worker Education Institution Address Line 2: