- Fujifilm (College Station, TX)
- …understanding of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Catalent Pharma Solutions (Greenville, NC)
- …analytical/microbiology laboratories, and manufacturing operations. The Computer Systems Validation Lead performs technical and quality functions to ensure ... . + Assist in the implementation for improved site validation activities and the quality systems related...least 2 years in the areas of Equipment/Facilities and Computer Validation as a substitute is required.… more
- IQVIA (Cary, NC)
- …proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and ... actions (CAPA) are followed-up on and implemented. + Manage/oversee quality events updates in the electronic quality ...compliant with 21CFR Part 11. + Expert knowledge of Computer Systems Validation (CSV) in a life… more
- Lilly (Lebanon, IN)
- …- Computer Systems Quality Assurance is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. This ... relevant experience + 1+ years of experience in Automation/QC Labs/IT, Quality , or computer system validation in the pharmaceutical industry **Additional… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... business expectations. **Key Responsibilities:** + Define and maintain a global Computer System Validation (CSV) methodology and policies/procedures in… more
- Belcan (Indianapolis, IN)
- Computer System Validation (CSV) Program Lead Job Number: 352755 Category: -MFG & Supply Chain SBU Description: Job Title: CSV ( Computer System Validation ... 1st #CSVLeadership #PharmaValidation #ComplianceExcellence Overview: We are seeking an experienced CSV ( Computer System Validation ) Program Lead to lead the … more
- Boehringer Ingelheim (Athens, GA)
- … related issues and/or support continuous improvement. + Trains personnel in quality and validation principals + Supports Engineering and departments in ... reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation … more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. +… more
- Lilly (Indianapolis, IN)
- …Systems Quality (GISQ) organization. GISQ is accountable for defining Computer System Validation (CSV) standards and providing thought leadership for ... and related testing and validation + Experience in computer system quality assurance, preferably with AI/ML systems. **Additional Preferences:** + Knowledge… more
- Eastman (Kingsport, TN)
- …more information, visit www.eastman.com. Role Profile Under minimal supervision, the Global Quality Validation Representative based in Kingsport, TN, will take ... use every day. With the purpose of enhancing the quality of life in a material way, Eastman works...Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity… more
- PCI Pharma Services (Rockford, IL)
- …setting, and effective organizing and assigning of work. + Reviews and approves quality validation documents including, but not limited to, statements, plans, ... variables. + High Standard of Report Writing **Preferred:** + Experience with quality validation documents including, but not limited to, statements, plans,… more
- Abbott (Austin, TX)
- …and oversight on product, process, and equipment related changes and implementations ( validation & change control). Specifically, + Provide quality support and ... assessing impact, and resolving unexpected events or issues which occur during validation . + Perform quality oversight & approval of equipment, process,… more
- Colgate-Palmolive (Morristown, TN)
- …& critical utility systems, computer control systems, etc. Ensures site Validation Program appropriately connects to other plant quality systems such as ... the site Validation Program to ensure compliance with Colgate Global Quality and regulatory requirements. Owns the site Strategy to ensure coverage of all… more
- Kelly Services (Deerfield, IL)
- …**Top 3-5 Must Have Non-negotiable Skills Required** 1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical 2. ... will own key tasks, demonstrate solid knowledge of validated systems and computer system validation , require moderate direction, give minimal guidance to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for… more
- PCI Pharma Services (Philadelphia, PA)
- …and shape the future of PCI. Job Title: **Sterilization** **Manager - Validation , Sterility Assurance, and Utilities/Facilities** Department/Group: Quality / ... Team and PCI PHL Customer Programs. Participate in site quality management reviews and reports on Validation ...experience + Statistical and Advanced Mathematical Skills + Advanced Computer Skills: Ability to perform the most complex … more
- Microsoft Corporation (Hillsboro, OR)
- … Computer Science, or related field. + Applied understanding of Computer Architecture and CPU/SoC validation principles, including: Understanding of SoC ... worldwide and we are looking for a **Senior SoC Hardware (Analog/Power) Validation Engineer** to help achieve that mission. Microsoft's mission is to empower… more
- Catalent Pharma Solutions (Madison, WI)
- …has oversight of the validation program, including commissioning and qualification, cleaning validation , and computer system validation as well as the ... **Engineer III - Validation ** **Summary** Catalent Biologics is a fast-growing business...is positioned to drive significant growth for Catalent. The Quality Assurance department is responsible for all aspects of… more
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