- Lilly (Indianapolis, IN)
- …technical guidance and leadership with non-conformance investigations, construction, equipment and computer systems design and validation , change control ... Engineer - Facility, Utilities, HVAC, and Equipment (FUME) & Computer Systems Quality (CSQ) QA is a...Influence and oversee the Commissioning and Qualification (C&Q) and Computer System Validation ( CSV ) of… more
- Lilly (Indianapolis, IN)
- …Servers, Network and Infrastructure and applications + Support the Process Control Validation Plan, CSV , Quality Documents, SOP's and Audit Readiness + ... a system owner for the electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems + Working experience administering… more
- J&J Family of Companies (Raritan, NJ)
- …in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation ( CSV ) Framework, assuring compliance across the ... action plans and closures. + Support incident management, CAPA and non‑conformance resolution for systems in scope. + Review and approve validation work and sign… more
- Lilly (Indianapolis, IN)
- …efforts, including hypercare support and frontline troubleshooting. + Ensure compliance with Computer System Validation ( CSV ) standards, including 21 CFR ... is ideal for someone who is passionate about technology, systems thinking, and supporting frontline manufacturing teams. **What You'll...or packaging operations. + Working knowledge of cGMP and Computer System Validation ( CSV ) frameworks… more
- Bristol Myers Squibb (Devens, MA)
- …projects, preferably in biologics or cell therapy manufacturing. + Strong understanding of CSV ( computer system validation ), data integrity, and regulatory ... of laboratory informatics systems (eg, LIMS, CDS, SDMS, ELN) and corresponding validation requirements. + Demonstrated experience leading complex IT or digital… more
- J&J Family of Companies (Jacksonville, FL)
- …for computerized systems . Implements new or re-engineered software validation systems / programs. Establishes "live documents" process and remediation ... policies and procedures. They will manage and conduct software validation projects in support of existing computerized systems...change request assessments ( 5%) + Develops and conducts SDLC/ CSV training for IT and Operations. (10%) + Review… more
- Quality Consulting Group (Juncos, PR)
- …Devices + Equipment Commissioning / Qualification + Process Validation 4. Computer System Validation ( CSV ) + Manufacturing, Packaging and Laboratory ... control and may develop those techniques including the measurement systems . + Ensures processes and procedures are in compliance...+ 4 years of relevant experience + Proficient in validation process, CSV , PV + Proficient in… more
- Astrix Technology (Fort Worth, TX)
- …+ Troubleshoot instrument issues and coordinate vendor repairs or service. + Support Computer System Validation /Software Assurance ( CSV /CSA). + Assist with ... documentation systems . + Understanding of data integrity and risk-based validation . + Instrumentation or metrology certifications (ASQ CCT, GAMP) a plus This… more
- J&J Family of Companies (Wilson, NC)
- …, internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** Computer System Validation ( CSV ) **Preferred Skills:** ... Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems , system standards, and...from clients. + Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP… more
- US Tech Solutions (New York, NY)
- …and reliability. **Operational Support & Incident Triage** + Use proprietary internal systems to initiate data ingestion, run validation tests, and ensure ... + Triaging and resolving technical escalations **Education:** + Bachelor's degree in Computer Science, Data Science, Information Systems , Engineering, or a… more