- Insmed Incorporated (Bridgewater, NJ)
- …and maintenance. The Manager will also serve as business owner for all computerized systems and will serve an active role in CSV activities including, but ... protocols and reports).Serves as the analytical development business owner for computerized system . As the AD Business owner, responsibilities will include,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry practices on computer validation , and Sarbox regulatory requirements of computerized systems Moderate knowledge of operating systems , relational ... and developing IT solutions. In the support role of existing systems , this role provides knowledge, testing, documentation, Service Level management reporting.… more
- Catalent (St. Petersburg, FL)
- …and could include all or some aspects of the Quality function.The RoleEnforce Computerized System Validation (CSV) guidelines, policies, and procedures for ... relevant experience will be considered.Pharmaceutical and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and general GxP… 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
- 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
- Astrix Technology (Brownsburg, IN)
- Validation Manager Manufacturing Brownsburg, IN, US Pay Rate Low: 120 | Pay Rate High: 140 + Added - 30/05/2024 Apply for Job _Rapidly growing Biotech ... covering equipment, utilities, sterilization, cleaning, aseptic processing, cleanroom qualification, computerized system . + Support change control, investigations,… 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …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
- 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
- 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
- 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
