Specialist, IT – GxP Technical Support

About the Role

We are seeking a motivated, detail-oriented Specialist, IT – GxP Technical Support to provide first level helpdesk support for GxP-regulated and business-critical systems. This role supports end users while helping maintain a secure, compliant, and audit-ready IT environment. The Specialist works closely with Quality Assurance (QA), Computer System Validation (CSV), Infrastructure, Security, Business System Owners, and vendors to ensure that regulated systems remain secure, compliant, and operational.

Responsibilities

• Provide Tier 1+ support for GxP and non-GxP systems, endpoint devices, business applications, and user access issues.
• Troubleshoot and resolve incidents affecting GxP-regulated applications, laboratory systems, quality systems, manufacturing systems, and supporting infrastructure.
• Manage incidents and service requests through ServiceNow, ensuring accurate documentation, classification, prioritization, escalation, and closure in accordance with SLAs and GxP procedures.
• Perform user provisioning, deprovisioning, and access modifications for GxP systems in accordance with approved access management procedures and segregation of duties expectations.
• Support Identity and Access Management platforms including Okta, Active Directory, and Microsoft Entra ID, including SSO and MFA troubleshooting.
• Assist with onboarding, offboarding, and role changes while ensuring appropriate approvals and audit trail documentation are maintained.
• Support Windows, macOS, mobile devices, Microsoft 365, and endpoint management platforms within regulated and non-regulated environments.
• Escalate GxP incidents to QA, CSV, Infrastructure, Security, System Owners, or vendors as required based on severity, risk, and potential regulatory impact.
• Maintain accurate IT asset inventory records and lifecycle documentation for regulated systems and endpoints.
• Create, update, and maintain SOPs, work instructions, knowledge base articles, and controlled support documentation.
• Support internal and external audits by providing documentation, evidence, ticket history, and system support records as required.

Requirements

• Bachelor’s Degree in Information Technology, Computer Science, Engineering, Life Sciences, or related discipline preferred; equivalent education and experience will be considered.
• 1-3 years of experience supporting IT systems within a pharmaceutical, biotechnology, medical device, or other regulated environment.
• Experience supporting GxP-regulated applications, systems, equipment, or processes.
• Experience supporting Windows 10/11, macOS, Microsoft 365, and enterprise endpoint technologies.
• Experience with user lifecycle management, access provisioning, SSO, MFA, and identity platforms such as Okta, Active Directory, and Microsoft Entra ID.
• Understanding of change management, incident management, deviation management, and CAPA processes within regulated environments.
• Experience supporting laboratory instruments, manufacturing systems, quality systems, or validated software applications is highly desirable.
• Excellent written and verbal communication skills with the ability to interact effectively with technical and non-technical users.
• Demonstrated ability to manage multiple priorities while maintaining a high degree of accuracy, documentation quality, and compliance.
• Strong customer service orientation with a focus on responsiveness, professionalism, and clear communication.
• Ownership and accountability for tickets, tasks, and issues through complete resolution.

Physical Requirements

• Ability to work outside of standard business hours on an occasional basis to support GxP activities, system implementations, upgrades, maintenance activities, audits, inspections, and critical issue resolution.
• Ability to lift, carry, push, and/or pull equipment and materials weighing up to 25 pounds on an occasional basis.
• Ability to wear required personal protective equipment (PPE) and comply with all safety, security, and GxP requirements while working in regulated environments.
• Ability to work in both office and regulated laboratory, manufacturing, and data center environments.

Pay

The expected salary range for this position is $54,000 to $72,000.

Benefits

• Competitive total rewards package including equity participation and 401(k) matching.
• Medical, dental, and vision insurance.
• Life insurance.
• Generous paid vacation and holidays, including global shutdown days between Christmas and New Year’s.
• Wellness resources and employee support programs.
• Bonuses (short-term incentives).
• Certain positions eligible for equity awards (long-term incentives).