| Urgent opening for validation CSV Engineer in Jacksonville, FL at Jacksonville, Florida, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2299282&uid= From: Kundan Mishra, ATS INC [email protected] Reply to: [email protected] Hello, Greetings, Hope you are safe & healthy. My name is Kundan Mishra. I am a Technical Recruiter with Altitude Technology Solutions (ATS) INC. The purpose of this email is to serve as an invitation to discuss the opportunity below with our customer that I think you or your candidate would be a great fit for. Position: CSV Engineer Location: Jacksonville, FL Required Skills: CSV, SDLC, CCB, IQ, URS, SDS and RTM Job Description Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required. Working knowledge of GAMP5 and SDLC is required. Working knowledge of regulations for electronic records, electronic signatures, and data integrity is required Experience with change management and a strength with technical writing is required. Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations is required. Medical device process validation experience is preferred. Experience in Quality Auditing and notified body inspections is preferred. Experience in Quality Systems process development, support, integration or enhancement is preferred. Experience with training or coaching others is preferred. Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE) is preferred. A minimum of 4 years of experience in a regulated environment is required Desirable Skills: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation department. Implement new or changed programs/policies/procedures related to CSV and support SDLC & software validation policies, procedures and processes for computerized systems. Facilitate change validation as part of the Change Control Board (CCB) as the SQE representative. Lead the Installation Qualification (IQ) of manufacturing lines. Support CSV improvement initiatives in manufacturing. Champion cross-collaboration across functions, sites and operating companies in the area of CSV. Identify and resolve barriers that impede business needs. Collaborate with Franchise Quality in the deployment (design, implementation and post-monitoring) of Quality System initiatives impacting the site that promote the continuous improvement of the Quality System and ensure continuity of the application of globally shared processes and systems at the site level. Support compliance activities by participating in audit readiness, support internal and external audits pertaining to CSV. Serve as the Subject Matter Expert for CSV and manage investigations, responses, and remediation of site-specific CSV audit observations Thanks & Regards Kundan Mishra Sr. Technical Recruiter [email protected] Keywords: access management Florida Urgent opening for validation CSV Engineer in Jacksonville, FL [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2299282&uid= |
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| 03:59 AM 29-Mar-25 |