Position SummaryThe 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.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
$54.52 (entry-level qualifications) to $60.57 (highly experienced) per hour
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
