Top 3 Must Have's:
• In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP)
• Good understanding of Windows Desktop OS support tasks (7 - Win 10) and ability to setup brand new systems
• Hands onexperience in Installation and configuration of Lab/Manufacturing computer systems in a regulated GMP environment
This position requires strong workstation support skills with key focuses including, but not limited to:
• Providing direct support to end-users ranging from Tier 1 - 2 type issues
• Continue to develop an understanding of the business processes and all applicable procedures
• In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP)
• Good understanding of Windows Desktop OS support tasks (7 - Win 10) and ability to setup brand new systems
• Install and configure Lab/Manufacturing computer systems in a regulated GMP environment
• Oversee and support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems
• Work with vendor's tech support teams to resolve application errors as need
• Serve as the System Owner/Manager and perform administrative tasks on QC/Manufacturing instruments/systems such as user additions, removal, method/assay updates
• Partner with local QA/QE to evaluate and test new upgrades/patches to Operating Systems/applications and write install instruction for Lab/MFG managed services support personnel
• Participate in process re-engineering workshops with business and IT stakeholders
• Perform impact assessment on changing product capabilities, including impact to integrated (boundary) systems
• Respond to IT support requests to address operational issues with enterprise and quality applications
• Meet with internal clients and stakeholders to diagnose software and middleware issues
• Align with other manufacturing sites and corporate IT to ensure global consistency
• Review/develop SOPs related to administration and installation of applications used in the lab/manufacturing environments
• Troubleshooting and replacement of hardware component and systems
• System imaging software experience and ability to learn new in-house method
• Knowledge of simple AD account management and network connectivity requirements
• Able to trace phone and network patch cables to wall jacks with the aid of network testing devices
• In depth knowledge of Microsoft O365 applications and other productivity applications such as Adobe Acrobat
• Command of IT ticketing system use and effective workload management;
• Proactively monitors and identifies trends and behaviors in systems support and address the findings or escalate to other IT team resources
• Able to follow other specific troubleshooting steps and continuously update and create additional knowledge articles
• Contributing to timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance
Minimum Qualifications
Education, Certifications & Experience
• MA/MS degree with 3+ years of Operations and/or Manufacturing, IT and/or OAT (Operational automation Technology) experience OR
• BA/BS degree with 5+ years of Operations and/or Manufacturing IT and/or OAT (Operational automation Technology) experience OR
• High School Degree with 4+ years of IT Operations and/or Manufacturing IT and/or OAT (Operational automation Technology) experience