- 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
- Unither Pharmaceuticals (Rochester, NY)
- …ensures that all laboratory systems composed of equipment, instruments and computerized systems are properly maintained, qualified, calibrated, secured to be ... efficiencies and all secured data. ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Laboratory Computerized Systems Management Manage all software upgrades and laboratory… more
- Jacobs (Conshohocken, PA)
- …and Qualification o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems o ASTM E2500 Standard Guide for Specification, Design, and ... we're making a difference. As a Commissioning, Qualification, and Validation (CQV) Project Manager , you'll join our...be accountable for establishing appropriate procedures regarding handover of systems from construction to C&Q team as well as… more