| Job Description - Validation Engineer - Foster City, CA (Hybrid) at Foster City, California, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2020841&uid= Greetings, I hope this email finds you well. My name is Sparsh Gupta, and I am a Technical Recruiter from Empower Professionals Inc. I came across your profile and wanted to reach out regarding a role Validation Engineer with one of our Clients. Please let me know if you are available in the job market and interested in this role (see job description below) - if so, we can connect and speak further. I would need your updated resume to proceed and can give you a call as soon as I have it. Also please let me know when we can connect on call for a short conversation. Role: Validation Engineer Location: Foster City, CA (Hybrid) Duration: 12+ Months Must have: Computer system validation using GAMP 5 methodology 21 CFR part 11 and Annex 11 Change Control and Impact Assessments Responsibilities: Responsible for authoring and/or revising the following documents related to GxP Systems (specifically GE iFix & Rockwell FactoryTalk View based Environmental Monitoring Systems): User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, Installation, Operational and Performance Qualification protocols. Responsible for execution of authored protocols. Author change management records, create or revise impacted documentation and execute change implementation tasks. Develop decommissioning and data migration strategies for legacy systems and author validation deliverables for decommissioning systems. Collaborate with cross-functional teams in authoring CAPAs and Deviations. Perform periodic system maintenance activities such as, account management, system maintenance, system audit trail review and backup and restore testing, etc. Maintain system specific operational documentation such as SOPs, work instructions, business-enabling documents, training plan as well as contribute to authoring and maintenance of business SOPs. Coordinate with IT stakeholders for maintenance of system infrastructure, security, and vulnerability management. Coordinate with business stakeholders to constantly align with their needs and deliver technical and compliant solutions, as required. Coordinate with software vendors for change deployment, scheduling of system maintenance activities and issue management. Requirements: Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems. System Administration experience is preferred but not required. Must be experienced in computer system validation using GAMP 5 methodology. Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to environmental monitoring systems. Experienced in developing validation methodology for global implementation of systems. Experience with validation methodologies and SDLC best practices. Proficient in current Good Manufacturing Practices (cGMPs) requirements. Nice to Have: Process Control Systems / Environmental Monitoring Systems technical proficiency Data Migration experience Project Management Thanks & Regards Sparsh Gupta Technical Recruiter | Empower Professionals ...................................................................................................................................... [email protected] 100 Franklin Square Drive Suite 104 | Somerset, NJ 08873 www.empowerprofessionals.com linkedin.com/in/sparsh-gupta-b97778271 Certified NJ and NY Minority Business Enterprise (NMSDC) -- Keywords: access management information technology California New Jersey New York Job Description - Validation Engineer - Foster City, CA (Hybrid) [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2020841&uid= |
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| 09:45 PM 17-Dec-24 |