- PACIV (IN)
- PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and ... Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). Job Description: The Validation … more
- Novo Nordisk (Bloomington, IN)
- …+ Draft, review, execute, and approve protocols and summary reports related to Automation System Validation ( CSV ).. + Review and approve changes to ... Engineering Skills: + Act as key Subject Matter Expert (SME) for automation design, systems integration and CSV (Automation Only) + Apply and enhance existing… more
- Novo Nordisk (Bloomington, IN)
- …+ Draft, review, execute, and approve protocols and reports related to Automation System Validation ( CSV ). This includes deviation reporting during execution ... audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for… more
- Lilly (Indianapolis, IN)
- …and mentorship in the execution of change controls, equipment qualification, process validation , computer system quality, deviations, and complaint ... cGMPs, Production Processes, Quality Systems , and FDA regulations + Experience supporting computer systems (eg CSV , CSQ, IDS experience) + Proficiency… more
- Bristol Myers Squibb (Indianapolis, IN)
- …of Cybersecurity, patching and IT Life Cycle Management (LCM)." + Understanding of computer system validation ." **Physical Requirements:** + Standard office ... objectives at the site. The role will ensure the digital systems applications along with CSV for lab and process automation are enabled and maintained to… more
- Lilly (Indianapolis, IN)
- …non-terminal data, data flow mapping, records/data backup, archive and retention, computer system validation , infrastructure qualification, investigation, ... for all forms of data (electronic data, manual data), systems (integrated, stand-alone), areas (production and support areas/processes), processes (manufacturing,… more
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