Senior, IT GXP Systems Specialist

Essential Functions

• Implement and maintain software supporting GxP laboratory equipment.
• Responsible for daily GxP system operations, maintenance, and support.
• Create and maintain system documentation, specifications, IT administrative and security SOPs and execute test scripts related to GxP systems to support Computer System Validation Systems Validation (CSV).
• Follow IT and Quality processes to maintain systems in a validated state and ensure GxP systems are in compliance with 21 CFR part 11.
• Manage incident tickets, perform troubleshooting and periodic assessments of systems.
• Evaluate and assign appropriate data security, user roles and privileges for data integrity.
• Coincide with system vendors and business partners in various functions to schedule upgrades, maintenance, and support activities.
• Create and maintain service catalog related to IT GxP operations.
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs.

Education & Experience

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field with 4+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required; OR
• High School Diploma or equivalent with 8+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required.
• 1+ years of providing IT support in a GxP environment is preferred.

Knowledge, Skills & Abilities

• Strong understanding of Windows operating systems, networking protocols (TCP/IP, DNS, DHCP), VLANs, wireless access points, IP addresses, group policies, and user/group management security.
• Working knowledge of FDA cGMP and cGLP regulations including 21 CFR Part 11.
• Strong experience in customer service, incident management, and problem management.
• Strong technical, analytical, and business acumen with excellent attention to detail.
• Strong interpersonal and communication skills.
• Strong troubleshooting and problem-solving skills, with the ability to learn and adapt to new technologies and processes quickly.
• Able to manage multiple projects simultaneously while performing day-to-day activities.
• Able to present technical information to management, employees, and other departments.
• Excellent interpersonal, written and verbal communication skills.
• Excellent ability to write, review, edit, and approve technical documentation.
• Able to pivot and work well in complex, fast-paced environments.
• Proven ability to work collaboratively in a matrix organization.