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
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