- Cytiva (Miami, FL)
- …(PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation ( CSV ) protocols and/or Plans and Reports.Assist ... and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into...Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site… more
- Beam Therapeutics (Cambridge, MA)
- …understanding of application lifecycle management and support best practices. Familiarity with Computer Systems Validation ( CSV ) processes, including ... to support Beam's Medical Affairs team by managing application support and system implementations, while also leading small to mid-size IT projects across the… more
- Fujifilm (Holly Springs, NC)
- …smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description What You'll Do Ensures that Computer System Validation is performed to a ... summary reports) Helps to assess the impact of Computer System modifications through the change control...through the change control process Helps to maintain the validation status of DSM Automation Computerized Systems … more
- Quality Consulting Group (Villalba, PR)
- …control of Medical Devices Equipment Commissioning / Qualification Process Validation Computer System Validation ( CSV ) Manufacturing, Packaging and ... Laboratory Equipment Technical experience (Trouble shooting) or any similar experience or background Quality / Process Control / Assurance of Medical Devices Availability for 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all… more
- Syner-G BioPharma Group (San Diego, CA)
- …of automated production systems , with a concentration on computerized equipment and systems validation . Report writing experience for IQ, OQ, PQ, and CSV ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification. Support validation … more
- Katalyst HealthCares and Life Sciences (Lake Bluff, IL)
- …of JIRA, JAMA software and test automation is a plus. Key Words to search in Resume Computer System Validation , 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ... system is in a validated state and take appropriate actions. Perform System Retirement/Decommissioning of systems not in business. Work closely with software… more
- BioSpace (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 with… more
- FITS LLC (Manati, PR)
- …YOU WILL: (The day-to-day on the job) Proficient knowledge of computer system life cycle concepts, change control systems , and FDA regulatory requirements, ... of the science and physics involved in designing, installing, commissioning, and validation /qualification of computerized systems and PLCs as applied to… more
- Cognizant (Muskegon, MI)
- …10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client ... that customer quality expectations are met with respect to CSV and provide guidance to the Client. Systems...MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities… more
- Charles River Laboratories (Memphis, TN)
- …Owner, IT, QA, Departmental Managers, vendors, etc). * Provide guidance and support on Computer System Validation ( CSV ) practices, helping others develop ... and maintaining quality throughout. * Prepare clear and concise validation deliverables for computerized systems , including ...in the writing of SOPs as they pertain to computer system validation and data… more
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