QC Data Infrastructure Engineer

Our client is seeking a QC Data Infrastructure Engineer to support quality control laboratory data infrastructure within a GMP-regulated pharmaceutical environment. The role will focus on MODA master data creation and verification, ELN template management, and SDMS administration, while ensuring data integrity and compliance with applicable quality standards.

• Create, configure, and verify MODA master data.

• Manage and maintain ELN templates and related laboratory data structures.

• Support SDMS administration and QC laboratory data systems.

• Perform data administration activities for laboratory IT systems.

• Ensure QC data and system activities comply with GMP requirements and ALCOA+ data integrity principles.

• Support environmental monitoring (EM) and sterility assurance activities within a cGMP environment.

• Collaborate with QC, IT, Quality, Validation, and laboratory teams to maintain reliable and compliant data infrastructure.

• Support data verification, troubleshooting, and system-related investigations as needed.

• Maintain appropriate documentation for system and data administration activities.

Required Qualifications

• Previous MODA data configuration experience is required.

• QC laboratory experience with data administration for laboratory IT systems.

• Pharmaceutical/GMP experience, including environmental monitoring and sterility assurance in a cGMP environment.

• Strong understanding of data integrity and ALCOA+ principles.

• Experience with ELN as a power user or data steward.

• Strong documentation, analytical, and troubleshooting skills.

Preferred Qualifications

• Experience in ATMP or Gene Therapy manufacturing/QC.

• Experience with NuGenesis ELN template configuration.

• Computer System Validation (CSV) experience.