- Eisai, Inc (NJ)
- …within eTMF system related inspection readiness activities.Must have good understanding of computer systems validation and related processes. Knowledge and ... of eTMF including, but not limited to version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic team at Formation Bio. ... experts in the pharmaceutical industry to develop reliable and scalable ML systems that drive strategic business decisions and improve clinical outcomes.If you are… more
- Merck & Co. (North Wales, PA)
- …- Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and ... initiative teams - Education and Minimum Requirement : BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field… more
- Merck & Co. (North Wales, PA)
- …assigned projects. Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area (TA) standards and following ... strategic initiative teams.Eduactional Qualifications:Must have a master's degree in computer science, Statistics, Applied Mathematics, Life Sciences, Engineering or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Eisai, Inc (Nutley, NJ)
- …with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively ... and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing ... Catalent Pharma Solutions in Harmans, MD is hiring a Senior Engineer, CSV who is responsible for participating in...involved in processing steps related to equipment, facility/utility and computer systems validation . This role… 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 ... goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… 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 ... Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
- NVIDIA (Santa Clara, CA)
- …1999 sparked the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU deep learning ignited ... of technological advancement. As a member of our Mixed Signal Design Validation team, you will lead bring-up activities and characterization of high-speed mixed… more
