- Catalent Pharma Solutions (Greenville, NC)
- ** Computer Systems Validation Lead** **Position Summary** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical ... potent handling capabilities, ideal for orphan or targeted drug development. The Computer Systems Validation Lead provides direct computer systems… more
- PCI Pharma Services (Bedford, NH)
- …and database management skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems /software/equipment supporting GMP ... Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations and… 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 ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the… 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 ... will work with lab & process automation, large corporate systems , small biotech systems , across all functions...corporate policies and procedures related to all aspects of computer system validation and applicable local processes… 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 ... risks involved in processing steps related to equipment, facility/utility and computer systems validation . This role will help develop and/or review… more
- Eastman (Kingsport, TN)
- … Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements. ... systems . Responsibilities + Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test protocols, reports, and all… more
- Adecco US, Inc. (Anasco, PR)
- …methods (eg, types, levels, strategies, tools and documentation). Have an understanding of Computer Systems Validation Life Cycle and regulatory requirements ... an understanding of verification and validation processes, including early software or computer systems defect detection and removal, inspection, and testing… more
- Editas Medicine (Cambridge, MA)
- …activities + Experience with Facility/utility qualification activities. + Should have experience with Computer Systems Validation for systems like Veeva, ... with benchtop equipment commissioning and decommissioning processes. + Extensive experience with Computer Systems Validation (CSV) and familiarity with GAMP… more
- Bayer (Berkeley, CA)
- …utilities, facilities, SIP, temperature mapping validation experience is desired; + Computer systems validation experience is desired; + Prior experience ... of risk-based approaches to validation ; + Ability to set validation strategy for complex systems and execute validation plans and to drive them to… more
- Lilly (Indianapolis, IN)
- …owned computer systems used within PRD are compliant with current computer systems validation expectation. This will include coordinating with the ... responsibilities include: + Coach and mentor others in aspects of computer systems validation support, including System Development Lifecycle knowledge,… more
- Kelly Services (Deerfield, IL)
- …the work. The incumbent will own key tasks, demonstrate solid knowledge of validated systems and computer system validation , require moderate direction, give ... **Top 3-5 Must Have Non-negotiable Skills Required** 1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical 2.… more
- Curia (Albuquerque, NM)
- …of five (5) years' relevant experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP ... Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems… more
- Bristol Myers Squibb (Princeton, NJ)
- …as a member of a team. Additionally, you will support the execution of Computer Systems Validation processes. **Desired Candidate Characteristics:** + Prior ... methodologies preferred. + Knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Knowledge of cGXP and 21CFR Part11… more
- Lilly (Indianapolis, IN)
- …operations. . Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... vendors, and other relevant functional areas. **Basic Requirements:** . BS degree in Computer Science, Information Systems or related discipline . 3+ years of… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as ... rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi... Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global… more
- Astellas Pharma (Sanford, NC)
- …SDMS lab systems + Knowledge of manufacturing processes, equipment qualification and computer systems validation (CSV) according to GAMP 5 principles is ... the system administration, maintenance and enhancements to facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape to… more
- Colgate-Palmolive (Morristown, TN)
- …or equipment, water & critical utility systems , computer control systems , etc. Ensures site Validation Program appropriately connects to other plant ... activities, eg drafting/executing/completing equipment or instrument qualification, formula validations, computer system validation , etc.** + **Possess excellent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Specific experience with Veeva Vault products and reporting is a plus + GxP computer systems and validation experience + Knowledge of Quality Systems ... product families, materials, planned and manufactured batches/lots, suppliers/vendors, assets ( computer systems , instruments, equipment), clinical trials, etc.… more
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