- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and ... CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer... support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global… more
- BioAgilytix (Boston, MA)
- …Laboratory Systems Administrator will ensure smooth, compliant, and effective system operation, providing ongoing support and optimization for these ... systems while ensuring compliance with industry regulations and standards. Support and system administration for identified applicationsPerform *and lead… more
- Belcan (Indianapolis, IN)
- Computer System Validation ( CSV )...system requirements. * Provide mentoring and guidance on CSV processes to cross-functional teams. * Support ... Category: -MFG & Supply Chain SBU Description: Job Title: CSV ( Computer System Validation) Location:...including Validation Plans, Security Plans, and Test Plans. * Support the generation of project CSV documents,… more
- Curia (Albuquerque, NM)
- …role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems Engineer III will ... CSV Systems Engineer III in Albuquerque,...functional areas across the organization to maintain and improve computer system validation processes to ensure robust,… more
- Fujifilm (Holly Springs, NC)
- …2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation ( CSV ). This role provides input and determine action ... Maintains the validation status of Manufacturing and IT Computerized Systems + Manages the allocation of contract CSV... CSV processes and practices + Coordinates with Computer System vendors, as needed + Assesses… more
- Lilly (Lebanon, IN)
- …Lebanon. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will ... to enable a successful startup into GMP manufacturing operations. **Position Overview** As a Computer System Validation Engineer, you will play a pivotal role in… more
- Verista (New Brunswick, NJ)
- …+ Conduct risk assessments and implement mitigation strategies for computerized systems . + Oversee documentation lifecycle for CSV activities, ensuring ... to making an impact every day. Company Culture Guidelines & Values: + We empower and support our colleagues + We commit to client success at every turn + We have the… more
- Verista (Boston, MA)
- …Senior CSV Engineer/Analyst Responsibilities: + Provide IT CSV support to implement and validate electronic systems in accordance with corporate ... Company Culture Guidelines & Values: + We empower and support our colleagues + We commit to client success...Protocols, Trace Matrices and Summary Reports associated with validated computer systems + Engage in Quality process… more
- Pfizer (Sanford, NC)
- …support for different validation program efforts, including equipment validation, computer system validation, process validation cleaning validation. These ... validation efforts will help ensure that our equipment, systems , and processes are reproducibly functioning as intended to...or computer science). + Demonstrated experience with computer system validation - life cycle management.… more
- Carrier (Beverly, MA)
- …with business expectations. **Key Responsibilities:** + Define and maintain a global Computer System Validation ( CSV ) methodology and policies/procedures in ... validated systems and recommend level of validation support required. + Lead internal audits of CSV...the latest GxP regulations and industry best practices for Computer System Validation. + Conduct risk assessments… more
- PCI Pharma Services (Bedford, NH)
- …PCI. **JOB SUMMARY** The CSV Validation Engineer II shall support CSV team in maintaining the systems /software in its most current validated state. Shall ... system /software/equipment assessments, user requirements, and specification documents. + Support all CSV -required activities under a Change Control and… more
- Catalent Pharma Solutions (Harmans, MD)
- …in validation projects related to manufacturing equipment, critical computer systems and laboratory documentation to support the commercial GMP manufacturing ... **Senior Engineer, Computer Systems Validation** **Position Summary:** Catalent...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines;… more
- Herbalife (Lake Forest, CA)
- …based on the system functions and the workflow processes. * Support Computer System Validation ( CSV ) activities, as needed. * Deliver training to ... global Quality unit; this includes performing system administrative tasks and day-to-day support functions for Quality Systems , such as, but not limited to,… more
- Herbalife (Torrance, CA)
- …based on the system functions and the workflow processes. + Support Computer System Validation ( CSV ) activities, as needed. + Provide training to ... global Quality unit; this includes performing system administrative tasks and day-to-day support functions for Quality Systems , such as, but not limited to,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. **Summary** Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the... support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global… more
- Lilly (Indianapolis, IN)
- …include: + Coach and mentor others in aspects of computer systems validation support , including System Development Lifecycle knowledge, problem ... remediation efforts. + Influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation ( CSV ) of GMP assets including review… more
- Bristol Myers Squibb (Devens, MA)
- …people. + High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and ... computerized systems , as well as supporting computerized system validation ( CSV ) activities. This position work...& Job Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens Cell Therapy… 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 ... 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
- 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 ... the work. The incumbent will own key tasks, demonstrate solid knowledge of validated systems and computer system validation, require moderate direction, give… more
