- 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
- Takeda Pharmaceuticals (Boston, MA)
- …areas in the pharmaceutical industry and demonstrated knowledge of equipment, software and computerized system validation . + Knowledge of GXP data integrity ... therapies to patients worldwide. Join Takeda as a Senior Manager , Cell Therapy Systems and Validation...site including validation of equipment, software and computerized systems . + Understand development of CSV… more
- Bristol Myers Squibb (Bothell, WA)
- …cross-functional support within the department for quality oversight of qualification and validation activities, primarily around computerized systems and ... productivity. **Knowledge & Skills:** + Knowledge of cGMP regulations, automation / computerized systems standards, FDA, EMA and PMDA guidelines applicable to… 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
- Bristol Myers Squibb (Devens, MA)
- … validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to existing equipment and ... in their personal lives. Read more: careers.bms.com/working-with-us . The Manager , Sr. Validation Engineer I supports the...standalone/enterprise computerized systems with oversight of department management. + Author and… more
- Takeda Pharmaceuticals (Boston, MA)
- …**How you will contribute:** + Assess, qualify and validate equipment, critical systems (utilities), facilities, computerized systems , cleaning and ... best of my knowledge. **Job Description** **Job Title** : Validation Maintenance Manager **Location** : Lexington, MA...represent the respective validation elements to determine validation strategy and system validation … more
- ManpowerGroup (Rocky Mount, NC)
- …Relevant experience refers to validation of instruments including those with computerized systems (eg AA, DNA Sequencer, FT-IR, IC, ICP-MS, Keyence Instant ... role which, under the guidance of a more senior Validation Engineer or Manager , is responsible for...in validation of instruments including those with computerized systems (eg AA,DNA Sequencer, FT-IR, IC,… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …operations automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + ... validation studies for the following major disciplines and report to the Engineering Validation Manager at our location in Social Circle, GA. + Facilities,… 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
- ICU Medical (Austin, TX)
- …general project direction. Responsible for project progress. *Prepares, reviews, and executes computerized system validation protocols per local procedures ... may impact external relationships. *Serve as project coordinator or project manager for validation /qualification aspects of projects. *Delivers communications… more
- CSL Behring (King Of Prussia, PA)
- …+ Ensure IT procedures and tools integrate and align with QAIT and GxP computerized system validation (CSV) requirements. **Education** + Bachelor's degree ... throughout the life cycle stages from procurement, implementation, run, to decommissioning of computerized systems for US region. + Participate in project teams… more
- BeiGene (Emeryville, 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
- Bristol Myers Squibb (Devens, MA)
- …commissioning and qualification, computer systems validation , process validation , and technology transfer. The Digital Quality Manager , Quality ... systems validation (CSV) lifecycle documentation associated with manufacturing site computerized and enterprise systems , including but not limited to … more
- AbbVie (North Chicago, IL)
- …processes & technology usage. + Provide strategic input on the analysis of new computerized systems & software used for clinical trial data collection, quality ... assignment, & development opportunities for staff within responsibility. + Complete the validation of electronic systems , software & programs applied internally… more
- BeiGene (San Mateo, 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
- State of Colorado (Denver, CO)
- …assure access to vaccines and maintain the Colorado Immunization Information System (CIIS), a confidential, population-based, computerized information system ... to transfer automatically into CIIS. + Tracks all data validation activities and results within tacking system ....be invited to schedule an interview with the hiring manager . E-Verify: CDPHE uses e-Verify, an Internet-based system… more
- BioFire Diagnostics, LLC. (Durham, NC)
- … to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies. + Development of employees in ... Position Summary: The QC Microbiology/EM Laboratory Manager provides direct oversight and guidance in the...products are appropriately measured and monitored according to quality system requirements (eg, QSR and ISO9001/ISO13485). This position is… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …Able to interface well with peers and other department heads + Familiar with computerized systems and compliance requirements + Ability to produce high quality ... we do, create and deliver. We are currently searching for a ** Manager , Analytical Development** who will be responsible for managing analytical development… more
- Battelle Memorial Institute (West Jefferson, OH)
- …strategy for managing systems structures, and components. Utilizes site computerized maintenance management system (CMMS) for tracking of maintenance, ... change control/configuration management to include system design descriptions, system and component labeling, verification, and validation . + Evaluates… more