- Lilly (Pleasant Prairie, WI)
- …management expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working ... of experience in Computer System Quality Assurance/ Computer System Validation...and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations… more
- Novo Nordisk (Clayton, NC)
- …required + Minimum of four (4) years of experience in computer system validation or quality related discipline experience in pharmaceutical environment ... Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of...+ Understanding of system development lifecycle including validation of computer systems , operation… more
- J&J Family of Companies (Raritan, NJ)
- …Responsibilities:** + Provide preparation, generation and flawless execution of Computer System Validation for GMP Systems and Processes. + Collaborate ... searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to...systems such as electronic Quality Managements Systems (eQMS), Validation Management System ,… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… 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
- PCI Pharma Services (Bedford, NH)
- …team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems -ensuring everything from equipment ... regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system...systems that directly impact patient safety and product quality Join us and be part of building the… more
- Charles River Laboratories (Wayne, PA)
- …protocols]. + Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity. + Collaborate with cross functional ... / assist in the preparation of clear and concise validation deliverables for computerized systems , including ...related field. + _Experience:_ 1-3 years of experience in computer system validation within a… 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
- Regeneron Pharmaceuticals (Armonk, NY)
- …Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for ... Management System Framework, Quality Vault, Computer System Validation (CSV), and...IT team. + Can assign super-users and SMEs for Quality Vault systems and lead operational and… more
- Merck (Rahway, NJ)
- …the EMEA / AP or US region. **Primary Responsibilities:** + Delivery of best-in-class computer systems validation to capital projects. + Drive the adoption ... and coordinate activities across sites. + Ensure compliance with Computer Systems Validation (CSV) and...and Data Integrity to ensure manufacture and supply of quality pharmaceuticals. + Liaise with product teams/technology functions and… more