- 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
- 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
- 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
- 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 + ... 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
- 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
- J&J Family of Companies (Columbus, OH)
- …experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required * ... Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across...skills * Knowledge of SDLC Quality Management process and Computerized System Validation / Computerized … 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
- 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
- J&J Family of Companies (Columbus, OH)
- …ITIL frameworks is highly desirable * Knowledge of SDLC Quality Management process and Computerized System Validation principles a plus * Knowledge of Data ... accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with… 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
- Novo Nordisk (Plainsboro, NJ)
- …industry practices on computer validation , and Sarbox regulatory requirements of computerized systems + Moderate knowledge of operating systems , ... and developing IT solutions. In the support role of existing systems , this role provides knowledge, testing, documentation, Service Level management reporting.… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …include all or some aspects of the Quality function. **The Role** + Enforce Computerized System Validation (CSV) guidelines, policies, and procedures for ... experience will be considered. + Pharmaceutical and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and general GxP experience… more
- Atlantic Health System (NJ)
- …preceptor, and/or manager as needed Provides basic orientation and skills validation of newly hired Patient Care Technicians and Unit Representatives. Acts as a ... preceptor, and/or manager as needed Provides basic orientation and skills validation of newly hired Patient Care Technicians and Unit Representatives. Acts as a… 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
- J&J Family of Companies (Harrisburg, PA)
- …GAMP 5, and ITIL frameworks * Knowledge of SDLC Quality Management process and Computerized System Validation principles * HR, org development and/or change ... Senior Manager , Data Governance - 2406186161W **Description** Johnson &...It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial… 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