- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …policies to Daiichi Sankyo employees and contractors/consultants involved with GxP and Non-GxP computerized system validation and/or usage to assure an ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems … more
- WuXi AppTec (Philadelphia, PA)
- …process streamline, architecture upgrade, recipe delivery, and testing coordination.Follow the Computerized Systems Validation process and Software Lifecycle ... 32 facilities in 9 countries. The Senior IT Project Manager (MES) is responsible for leading multiple software projects...process flow and present it to customers Testing and Validation of MES.Partner with the functional groups within the… more
- Bristol Myers Squibb (Bothell, WA)
- …with Business Owners, Technical Owners and Quality to create, manage, and improve computerized systems validation deliverables for electronic systems ... CSV Senior Engineer / Manager works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is… more
- Amgen (Thousand Oaks, CA)
- …in this meaningful role. **Data Manager - Enterprise Asset Management/ Computerized Maintenance Management System ** **Live** **What you will do** Let's ... data as it relates to Amgen's Enterprise Asset Management (EAM) / Computerized Maintenance Management System (CMMS) application. **Responsibilities include:** +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …policies to Daiichi Sankyo employees and contractors/consultants involved with GxP and Non-GxP computerized system validation and/or usage to assure an ... diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems … more
- ICU Medical (Dublin, OH)
- …equipment functionality and use of automated control systems / computerized systems . Communicate and manage timelines for validation projects to project ... section assigned to: . Equipment . Automated process control systems / Computerized systems . Process &...Knowledge of validation theory and content of validation deliverables/activities o For Automated Systems : PLC,… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …operations automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + ... and aseptic processing validation . + Process and utility systems validation , temperature mapping, manufacturing equipment commissioning and qualification.… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …operations automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + ... of commissioning, qualification and/or validation studies and report to the Engineering Validation Manager at our location in Social Circle, GA. **How you… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …(FUE) qualification, Units operations automation qualification with Honeywell, Delta V, and PCL-based systems , Computerized systems validation , Cleaning ... validation of manufacturing equipment. + Process and utility systems validation , temperature mapping, manufacturing equipment commissioning and… more
- Fresenius Medical Center (Lexington, MA)
- …management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR ... access servers/background of systems + Support with system testing during validation of software toolings...software validation knowledge + Microsoft Windows server systems Management + Relevant experience with Quality system… more
- BeiGene (San Mateo, CA)
- …execution of implementation plans/qualification tests + participate in the authoring of computerized system validation documentation Analyze user enhancement ... experience implementing technical solutions (workflows, objects, security) and validating GxP computerized systems + Strong process improvement skills and… more
- Catalent Pharma Solutions (Manassas, VA)
- …technical specifications with detail explanations of completed design + Experience with computerized systems validation , GXP assessments, and/or change ... **IT Manager , Quality Systems ** **Position Summary:** Catalent...of the Catalent organization to maintain alignment of business system fit, form and function with operational objectives. This… more
- BeiGene (Emeryville, CA)
- …execution of implementation plans/qualification tests + participate in the authoring of computerized system validation documentation Management of system ... quality and regulatory business processes. + Direct hands-on experience implementing GxP computerized systems and maintaining validated state. + Strong process… more
- Fresenius Medical Center (Lawrence, MA)
- …be providing the business support during internal and external audits of computerized systems . PRINCIPAL DUTIES AND RESPONSIBILITIES: + Interpret companywide ... PURPOSE AND SCOPE: The Manager , Software Quality Engineering is responsible for ensuring...external colleagues to influence or plan and execute computer system validation strategies for implementation. + Provide… more
- Amgen (Holly Springs, NC)
- …Assisting with review of validation documents to support equipment and computerized system onboarding. + Create and collaborate on Data Integrity Assessments ... functionality of the labs. + Support Change Control and Validation of Laboratory electronic systems during facility...start up. + Business subject matter expert for laboratory computerized systems + Establish and maintain … more
- University of Kansas (Lawrence, KS)
- …HR/Pay system as needed. + Monitors various interfaces, reviews and resolves system validation reports. Interfaces are internal and external to KU. Knowledge ... working with or leading a team. 4. Experience with validation of System Data (eg, Human Capital...). 2. Experience with implementation or functional testing of computerized systems . 3. Detailed and accurate work… more
- Fresenius Medical Center (Lawrence, MA)
- …manages internal and external regulatory audits/inspections by presenting and defending system validation projects and documentation during audits and FDA ... and/or leads business teams and IT to ensure that computerized quality systems are compliant with FMCNA...Expert. + Provides guidance/direction to external contractors working on system validation projects. + Ensures that all… more
- WuXi AppTec (Philadelphia, PA)
- …streamline, architecture upgrade, recipe delivery, and testing coordination. + Follow the Computerized Systems Validation process and Software Lifecycle ... 32 facilities in 9 countries. The Senior IT Project Manager (MES) is responsible for leading multiple software projects...process flow and present it to customers Testing and Validation of MES. + Partner with the functional groups… more
- Digital Prospectors (Portsmouth, NH)
- …and Responsibilities (but not limited to):** + Manage and plan the work of the computerized system validation project team. + Assess workload and communicate ... to apply lessons learned as we proceed with the system validation as part of Project Lynx....management, and leadership. + Present and defend the computer systems validation program and acceptance criteria to… more
- Bristol Myers Squibb (Phoenix, AZ)
- …deliverables during the design, delivery, commissioning of good manufacturing practices (GMP) computerized systems at the Phoenix site. + Provides support to ... systems as required. Routine support for GMP computerized systems at the Phoenix Site +...document changes/creation as necessary. + Provides advanced training to system end users. + Ensures systems are… more
