GxP Systems Administrator / CSV Lead

We are seeking an experienced Senior GxP Systems Administrator & Validation Specialist to support and manage regulated systems within a life sciences environment. This role is responsible for system administration, computer system validation (CSV), operational support, infrastructure management, and compliance activities to ensure reliable, secure, and compliant business and GxP applications., The ideal candidate will have extensive experience supporting validated systems, managing quality and compliance processes, leading validation activities, and working closely with cross-functional teams in a regulated pharmaceutical or biotechnology environment., * Provide operational and maintenance support for GxP and business applications, including incident management, user access administration, system monitoring, and issue resolution.

• Lead Computer System Validation (CSV) activities, including authoring, reviewing, and executing validation deliverables and protocols throughout the system lifecycle.
• Support audit readiness and maintain compliance with GxP, FDA, and regulatory requirements.
• Manage quality events, including Change Controls, Deviations, CAPAs, and related documentation within Quality Management Systems.
• Execute periodic system maintenance activities, including system assessments, backup and restore testing, disaster recovery validation, and server maintenance.
• Manage infrastructure lifecycle activities, including server upgrades, migrations, decommissioning, and cloud resource optimization.
• Drive security and vulnerability remediation efforts, including patch management and compliance monitoring.
• Support system enhancements, integrations, and migration projects, including on-premises to cloud transitions.
• Facilitate Agile/Scrum activities, including sprint planning, daily stand-ups, task tracking, and project reporting using JIRA and/or Azure DevOps.
• Participate in software quality assurance (SQA) testing and continuous improvement initiatives.
• Develop and maintain operational dashboards, reports, and performance metrics.
• Deliver system training and provide guidance to business stakeholders and end users.
• Collaborate with Quality, IT, Infrastructure, and Business teams to prioritize work and drive operational excellence., * * Are you a US Citizen or GCH? If on Visa please mention the Visa Status
• • Are you ready for background check and drug screen in accordance with the local law and regulations?
• • Please confirm your email address and contact number?
• • Cube Hub payroll is “Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?
• • What is your Expected Pay Range?
• • What is a good time to contact you?
• o Are you ok with following Shift (First Shift)

Do you have experience in Visio?, * Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field.

• 8+ years of experience supporting GxP-regulated systems in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Strong experience with Computer System Validation (CSV), including validation planning, protocol development, execution, and documentation.
• Hands-on experience administering validated GxP applications.
• Experience managing Change Controls, Deviations, CAPAs, and audit support activities.
• Strong knowledge of server administration, backup/restore processes, disaster recovery testing, and infrastructure support.
• Experience with AWS and/or Azure cloud environments.
• Experience with validation and quality systems such as ValGenesis, Veeva QMS, or similar platforms.
• Proficiency with JIRA, Azure DevOps, MS Visio, and related project management tools.
• Excellent communication, documentation, and stakeholder management skills.

Preferred Qualifications

• Experience supporting SAP environments or integrations.
• Experience with automation technologies and process optimization initiatives, including RPA.
• Experience supporting cloud migration and digital transformation projects.
• Knowledge of FDA 21 CFR Part 11, GAMP 5, and GxP compliance requiremenT, * Do you have 8+ years of experience in GxP system administration and Computer System Validation (CSV)?
• Have you authored, reviewed, and executed validation documentation such as Validation Plans, IQ/OQ/PQ, RTM, and Validation Summary Reports?
• Do you have hands-on experience with GxP applications in a pharmaceutical, biotechnology, or medical device environment?
• Have you worked with validation management tools such as ValGenesis, Kneat, or equivalent systems?

$85 - $90 an hour - Full-time, Contract, Pulled from the full job description

• 401(k)
• Health insurance
• Vision insurance
• Dental insurance, * 401(k)
• Dental insurance
• Health insurance
• Vision insurance