- Grifols Shared Services North America, Inc (Clayton, NC)
- …**Location:** Clayton NC **Overview:** The Engineer I - Validation / Engineer II - Validation / Validation Specialist I / Validation Specialist ... studies to meet timelines. * Evaluate and analyze qualification/ validation data collected, while verifying acceptability of...years experience which can include Co-Op or internship **Sr. Specialist I** - Validation - Requires a… more
- Catalent Pharma Solutions (Winchester, KY)
- **Associate Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... manufacturing, and roots in industry-leading Glatt technology. The Associate Validation Specialist position shall provide support for...FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes CV protocols/CV… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance....primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI),… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... If completed by an external company, the computer systems validation (CSV) specialist will be responsible for...and change in timelines. Understanding of FDA requirements for validation . The ability to analyze and interpret data… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist , assists with the validation activities throughout ... validation review and approval through the preparation, execution, data analysis, and report writing for IQ, OQ and...Perform compliance and technical reviews/approvals of protocols and protocol data + Review and approve validation failure… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist , you will ensure equipment, systems, and processes meet regulatory standards ... Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data ...the following years experience for each level: + QA Validation Specialist : 2+ years + Sr QA… more
- Boehringer Ingelheim (Athens, GA)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex ... and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts...and within cross function teams. + Ability to analyze validation and production data to assess compliance… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... controlled temperature unit (CTU) operations. + Ability to perform data review and trend analysis to support validation... data review and trend analysis to support validation conclusions. + Familiarity with laboratory sample handling and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory requirements ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**...carrying out, and reviewing master and completed qualification and validation protocols, summary reports and associated data … more
- SMBC (White Plains, NY)
- …continuous improvement of the model quality and governance. The Sr Model Validation Specialist applies numerical, statistical and qualitative knowledge to ... of the Risk Management Department, the Model Risk & Validation department enhances the Model Risk Management framework for...and model development; and working with large and complex data sets. Ability to apply regulatory requirements outlined in… more