对应专业:Biomedical Engineering, Chemical Engineering, Chemistry, or related.
所需培训:N
培训时长:
所需培训领域:
前置经验:N
经验时长（月）:
替代领域学历:N
替代专业:
可替代教育及经验组合:N
所需教育层级:
其他可替代教育层级:
认可经验年限:
境外教育背景:Y
可替代职业:Y
可替代职业时长（月）:36
可替代职业名称:See H.14.
是否为正常职业要求:N
是否需要外语:N
特殊技能: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.