- 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
- 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
- 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
- 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
- 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
- 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
- Google (Mountain View, CA)
- …+ Support the quality system electronic infrastructure by performing computerized system validations, audit preparedness activities, and improvements to the ... ISO13485 and 21 CFR Part 820 and Quality Management Systems (QMS). Preferred qualifications: + 2 years of experience...quality system . + Perform product qualification and product validation… more
- IDEX (Rutherford, NJ)
- …various types of measuring equipment: basic mechanical instruments, complex programmable vision systems and computerized data collection systems . **EDUCATION ... are, we have something special for you. **POSITION SUMMARY** The Quality Manager is responsible for ensuring our products are manufactured according to established… 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
- Brockton Hospital (West Bridgewater, MA)
- …data related to new hires, terminations, transfers and rate changes + Review month end system accrual report and assist staff in validation + Assist in month end ... direction of the Director, Payroll & Accounts Payable, the Manager will be providing leadership and assistance with the...upgrades + Coordinates month end closing including month end system accruals and validation + Perform compliances… more