Empower CDS Administrator/Specialist (RARR Job 5452)

Key Responsibilities:

• Provide technical expertise in Empower and other Chromatography Data Systems (CDS).

• Maintain and support current CDS systems, ensuring system stability and high availability.

• Troubleshoot and resolve end-user issues promptly.

• Administer CDS systems, including server maintenance, user management, and security controls.

• Perform backup, archival, restoration, and periodic system reviews.

• Support deployment, installation, and upgrades of CDS applications.

• Coordinate with multiple instrument vendors during application/instrument setup and instrument qualification.

• Guide and train site SMEs in Empower operations, ensuring smooth implementation and ongoing support.

• Develop, review, and maintain SOPs and compliance documentation for CDS systems.

• Validate laboratory and instrument software, including creation and execution of Master Validation Plans, functional requirements, risk assessments, and validation protocols.

• Ensure data integrity and compliance with 21 CFR Part 11, GxP standards, and other regulatory guidelines.

• Collaborate with cross-functional teams to ensure adherence to IT and business compliance requirements.

Required Skills:

• Strong technical knowledge of Empower CDS and other chromatography data systems.

• Hands-on experience in system administration, user management, and system configuration.

• Proficient in backup/restore operations, server maintenance, and application deployment.

• Experience with instrument qualification and vendor coordination.

• Strong understanding of GxP, 21 CFR Part 11, and compliance requirements.

• Experience in validation processes for lab systems and instruments.

• Excellent troubleshooting, analytical, and communication skills.