Top 3 Must Have's: In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and Good Documentation Practices (GDP) Good understanding of Windows Desktop OS support tasks (Windows 7 – Windows 10) and ability to set up new systems Hands-on experience in installation and configuration of lab/manufacturing computer systems in a regulated GMP environment Key Responsibilities: Provide direct support to end-users for Tier 1-2 issues Develop understanding of business processes and applicable procedures Support and oversee installation/configuration of regulated lab/manufacturing systems Collaborate with vendor tech support to resolve application issues Manage system administration tasks for QC/Manufacturing instruments Evaluate and test system upgrades/patches in partnership with QA/QE Participate in process re-engineering workshops Perform impact assessments for product capability changes Respond to IT support requests and diagnose software issues Coordinate with manufacturing sites and IT for consistency Develop SOPs for application administration and installation Troubleshoot hardware and perform system imaging Manage AD accounts and network connectivity Support productivity applications and manage IT tickets effectively Monitor system trends and update knowledge articles Communicate project updates and ensure compliance Minimum Qualifications: MA/MS degree with 3+ years of experience in Operations, Manufacturing, IT, or OAT OR BA/BS degree with 5+ years of relevant experience OR High School Degree with 4+ years of relevant experience #J-18808-Ljbffr TechDigital Group
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