GxP Systems and Support Administrator

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $130k - $150k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🖥️ Administration

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 8%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CAI

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

🏭 Manufacturing

Consulting • Healthcare • Manufacturing

CAI is a global company that provides comprehensive engineering and consulting services. Specializing in commissioning and qualification, building commissioning, asset management, quality and compliance, digital transformation, and automation, CAI focuses on helping clients in highly regulated industries such as biotechnology, pharmaceuticals, and healthcare. Their services are designed to enhance operational readiness, increase efficiency, and ensure regulatory compliance, thereby accelerating clients' paths to success. With a vast global presence, CAI serves a variety of sectors, offering expertise in projects ranging from biotech facilities to data centers.

📋 Description

• Administer GxP applications supporting infrastructure, including Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit Digital Validation Applications • Perform user account administration, role-based access control, and periodic access reviews • Manage system configuration, upgrades, and patches using established change control and validation processes • Maintain validated system state through documentation and validation procedures • Deploy and manage project-based instances of Digital Validation applications to support client services • Support Computer Software Assurance activities, including vendor testing package reviews, ad hoc testing, System Acceptance Testing, User Acceptance Testing, and Periodic Reviews • Create, review, and approve validation documentation, SOPs, work instructions, training materials, requirements, and technical documentation • Participate in risk assessments and validation impact assessments for system changes • Execute and document system change controls according to QMS requirements • Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues • Support CAPA investigations through technical analysis and corrective actions • Support internal, supplier, customer, and regulatory audits and inspections • Ensure audit trails, electronic records, and electronic signatures comply with regulatory requirements • Collaborate with vendors to resolve software defects and implement approved upgrades • Manage Tier 1 and Tier 2 technical support for applicable systems • Assist with cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring, and entitlement reviews • Train end users on system functionality and compliance requirements

🎯 Requirements

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or related field, or equivalent experience • 3–5+ years of experience administering IT systems and providing technical support • 2+ years of experience administering GxP-regulated systems in a pharmaceutical, biotechnology, medical device, or related regulated environment • Experience supporting validated computer systems throughout their lifecycle • Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity / Good Documentation Practices (GDP) • Experience collaborating with Information Security & Quality departments to ensure system compliance with internal and regulatory requirements • Experience with change management, investigations, deviations and other Quality-related procedures • Experience with Entra identity management, access controls, SSO & SCIM integrations • Knowledge of backup, recovery, and disaster recovery procedures • Excellent troubleshooting, analytical, and documentation skills • Strong communication skills and ability to work with cross-functional teams • Preferred: Experience administering CMMS, DVT or eQMS platforms in GxP environment • Preferred: Experience in GxP or Quality systems administration within a Professional Services or consulting organization

🏖️ Benefits

• Comprehensive Health Insurance coverage • 24 days of Paid Time Off • Company paid Life Insurance • Company paid Long Term Disability