- PCI Pharma Services (Bedford, NH)
- …/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, ... CSV Validation Engineer II shall support CSV team in maintaining the systems /software in...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV ** to ensure compliance of computerized systems with regulatory requirements ... providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Kedrion Biopharma (Melville, NY)
- …audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with ... _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play...GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing… more
- NTT DATA North America (MA)
- …readiness. + Ensure all integrations are validated, tested, and deployed in accordance with CSV ( Computer System Validation ) practices. + Support ... and implementation of integration solutions between SAP S/4HANA and external systems including Jaggaer, Fusion, Hyperion, Bank, Lockbox, LIMS, and 3rd-party… more
- Cornerstone onDemand (Billings, MT)
- …in a Technology company that supplies systems to customers who validate computer systems based on regulatory requirements and intended use + Demonstrated ... Validation ) lifecycle for Cornerstone's validated SaaS Learning Management System (LMS), which is deployed to customers in heavily...have ** + Bachelor's or Master's degree in Information Systems , Computer Science, or a related technical… more
- Astrix Technology (Atlanta, GA)
- …Bachelor's in chemistry or related field.Must have 2 years' experience with computer systems validation within the pharmaceutical or chemical ... proposals. Lead Validation Projects and manage the validation lifecycle of computer systems ,...Provide guidance and training to chemical laboratory staff on CSV principles, procedures, and best practices to foster a… more
- PACIV (Indianapolis, IN)
- PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and ... Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). Job Description: The Validation … more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Manager, Computer Systems Validation **City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA- CSV liaison with the ... and Validation organizations to support SaaS enterprise computer systems validation of Gene...QA oversight for the site on global implementation of CSV policy and review System Impact Assessment… more