- Astellas Pharma (Sanford, NC)
- …activities including but not limited to equipment, instruments, utilities, clean rooms, computer systems , and manufacturing process. + Evaluate and approve ... **Specialist, QA Validation (Onsite in Sanford, NC)** Do you want...oversight periodic review and lifecycle management activities for validated systems and computerized systems .Support revalidation as required… more
- Cognizant (Boston, MA)
- …guarantee seamless integration across platforms. + Coordinate Computer System Validation (CSV) activities to ensure alignment with FDA , EMA, MHRA, and ... , you will make an impact by driving the validation and testing strategy for Document Management Systems... validation and testing strategy for Document Management Systems (DMS) and ensuring compliance with global regulatory standards.… more
- Endo International (Rochester, MI)
- …testing of qualified GMP equipment, facilities, utilities, computer systems and sterilization processes. + Ensure validation activities comply ... + Develop and execute protocols (IQ/OQ/PQ) for equipment, utilities, facilities and computer systems (eg, HVAC, water systems , autoclaves, environmental… more
- Catalent Pharma Solutions (Kansas City, MO)
- …. The Quality Engineer II, Validation provides review and approval of all Computer System Validation and Equipment Qualification documents for the Kansas ... equipment design, equipment qualification, process validation , cleaning validation , computer system validation...are engineering sound and in compliance with all + FDA QSR/cGMP, ISO, and Quality Policies of the company… more
- Cognizant (Boston, MA)
- …**As an MES Validation Lead,** you will make an impact by driving Computer System Validation (CSV) initiatives within the Life Sciences domain, ensuring ... business units. **In this role, you will:** * Lead validation strategy and execution for Document Management Systems...systems . * Coordinate CSV activities in alignment with FDA , EMA, MHRA, and other global regulatory requirements. *… more
- Roche (Indianapolis, IN)
- …during audits and inspections. + You will champion compliance by safeguarding system validation and alignment with company procedures, maintaining readiness for ... will review or ensure the creation of deliverables from Test Managers and Validation Leads for GxP-relevant systems , upholding an oversight role while… more
- Genentech (Oceanside, CA)
- …ServiceNow ticketing system . + Any other duties as assigned/required for compliance/ validation of ITOT systems /processes. **Who you are:** + Has business ... pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations...you will have responsibilities for IT OT compliance and Validation ensure compliance for all IT Systems .… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting ... system lifecycle activities and 30% management of master systems data. **Key responsibilities:** + Manage and deliver on...Good Testing Practices and solid grasp of cGMPs and Computer System Validations. + Experience with electronic… more
- PACIV (San Juan, PR)
- …automation solutions servicing the Life Sciences sector, is looking for a Computerized System Validation (CSV) Specialist/Engineer IT Systems , for its Puerto ... Rico office. Job Description: The Computerized System Validation (CSV) Specialist/Engineer will be responsible...Education: Bachelor's degree in Engineering or related science studies ( Computer Systems or Engineering preferred). + Minimum… more
- NTT DATA North America (Highland Heights, KY)
- …Computer Science, or related discipline. Additional certifications in LIMS administration, Computer System Validation (CSV), GAMP 5, or Quality/Regulatory ... FDA 21 CFR Part 11, GxP, GLP, GMP, and ISO guidelines. Oversee system validation activities, risk assessments, and periodic audits. System Enhancements &… more
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