GxP Systems & Validation Administrator

Caiready; Northern (KY); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

CAI is seeking a GxP Systems and Support Administrator to join the IT & Information Security team. You will manage lifecycle administration of GxP and Quality governed systems within CAI, including eQMS, CMMS and Digital Validation systems.

The role is embedded in the IT & Information Security team with cross-functional reporting to Digital & Quality teams. You will perform validation, change control, testing, and user support across QA, IT, and client services, delivering validated, compliant

Formación

• 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, 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.

Responsabilidades

• Administer GxP applications supporting infrastructure: eQMS, CMMS, 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 & validation processes.
• Maintain validated system state through proper documentation and adherence to validation procedures.
• Deploy & manage project-based instances of Digital Validation applications to support client services.
• Support CSA activities including review of vendor testing, testing execution, System Acceptance Testing and User Acceptance Testing.
• Participate in the creation, review, and approval of 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 in accordance with QMS requirements.
• Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues.
• Support CAPA investigations by providing technical analysis and implementing corrective actions.
• Support internal audits, supplier audits, customer audits, and regulatory 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 & 2 technical support for applicable systems.
• Assist in cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring and entitlement reviews.
• Train end users on system functionality and compliance requirements.

Conocimientos

GxP systems administration

Regulatory compliance

Change management

Identity management

SO/SIM integrations

Educación

Bachelor's degree in IT/CS or related field

Equivalent experience

Herramientas

Entra ID

Descripción del empleo

CAI is seeking a GxP Systems and Support Administrator to join the IT & Information Security team. You will manage lifecycle administration of GxP and Quality governed systems within CAI, including eQMS, CMMS and Digital Validation systems.

The role is embedded in the IT & Information Security team with cross-functional reporting to Digital & Quality teams. You will perform validation, change control, testing, and user support across QA, IT, and client services, delivering validated, compliant