LIMS Administrator - CGMP, Validation & Training Lead

Jobtailor; Illinois; On-site; USD 70,000 - 100,000; Full time

Job summary

Fresenius Kabi in Illinois seeks an experienced LIMS Administrator to configure and maintain the LIMS, develop SOPs, and support global validation. You will coordinate cross-functional training across Microbiology, QA, Chemistry, and IQC, while ensuring compliance with cGMP and user specifications.

Strong English skills and laboratory informatics background are essential. Additional responsibilities include managing user accounts, updating product entries, monitoring network performance, and

Qualifications

• Bachelor of Science with minimum of 3 years of related experience preferred
• One-two years of pharmaceutical laboratory experience required
• Strong background in laboratory informatics and data systems
• Strong computer skills
• Excellent verbal and written communication skills
• Must effectively speak, read, write, and understand English
• Ability to independently understand policies, procedures, training materials, and workplace communications written in English

Responsibilities

• Configure and maintain the Fresenius Kabi LIMS computer system
• Establish and adhere to standard operating procedures and policies
• Support global validation and maintenance of the core system
• Maintain the LIMS and troubleshoot issues to ensure functionality
• Update and create product entries as needed
• Perform administrative functions such as account management
• Monitor network response times
• Support site validation for North America
• Coordinate cross-functional training and collaboration with Microbiology, QA, Chemistry, Stability, I&D, and IQC groups
• Ensure adherence to LIMS User Requirement Specifications and Design Qualification
• Participate in cGMP inspections and other audits as a company representative
• Coordinate document updates with USP, Product Specification, and MOA changes
• Develop, implement, and maintain LIMS Standard Operating Procedures
• Develop LIMS training modules and oversee end-user training
• Assist other Fresenius Kabi sites with implementation efforts
• Act as the site contact for the FK Global LIMS Administrator

Skills

LIMS Administration

Data Systems Management

SOP Development

Troubleshooting

Account Management

Document Coordination

Validation Support

Product Entry Management

Network Monitoring

Pharmaceutical Laboratory Experience

Education

Bachelor of Science

Tools

Fresenius Kabi LIMS

Job description

Fresenius Kabi in Illinois seeks an experienced LIMS Administrator to configure and maintain the LIMS, develop SOPs, and support global validation. You will coordinate cross-functional training across Microbiology, QA, Chemistry, and IQC, while ensuring compliance with cGMP and user specifications.

Strong English skills and laboratory informatics background are essential. Additional responsibilities include managing user accounts, updating product entries, monitoring network performance, and