Senior, IT GXP Systems Specialist

Position Summary

The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories, manufacturing and other regulatory operations. In close partnership with R&D, Quality Control, Engineering and Manufacturing functional leads, the position will provide technical leadership for new system deployments, upgrades, and maintenance of GxP systems including networked and non-networked stand-alone equipment at multiple ImmunityBio sites.

Essential Functions

• Responsible for implementing and maintaining 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.
• Coordinate with system vendors and business partners in various functions to schedule upgrades, maintenance, and support activities.
• Flexibility to provide 24 x 7 IT support for operations.
• Create and maintain service catalog related to IT GxP operations.
• Performs 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.
• Ability to manage multiple projects simultaneously while performing day-to-day activities.
• Ability 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.
• Ability to pivot and work well in complex, fast-paced environments.
• Strong leadership and influence skills with demonstrated business partnering approach.
• Proactive and self-motivated team player with exceptional organization, follow-through, time management, and communication skills.
• Proven ability to work collaboratively in a matrix organization.

Working Environment / Physical Environment

• This position will be onsite.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Participate in On-Call rotation for after-hours support and may work outside of established shift hours upon short notice to address any emergencies
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.