Manager 2 IT-Lonza Moda

Serve as the primary IT Subject Matter Expert (SME) leading the end-to-end implementation, configuration, and operational support of the Lonza MODA Environmental Monitoring (EM) system across regulated pharmaceutical operations.

Configure application workflows, sampling plans, alert/action limits, and microbiology testing methods in MODA.

Oversee and execute instrument interfaces and system integrations connecting MODA with environmental monitoring equipment (e.g., particle counters, air samplers), LIMS, MES, and enterprise quality platforms.

Coordinate cross-functionally with the Lonza vendor team, Quality Assurance (QA), QC Microbiology, and Manufacturing stakeholders.

Ensure rigorous adherence to GxP, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles across the MODA platform lifecycle.

Author, review, and maintain CSV lifecycle documentation (URS, FRS, IQ/OQ/PQ protocols, and Traceability Matrices).

Lead audit trail reviews, electronic signature configurations, security controls, and support regulatory inspections (USFDA, EMA, MHRA).

Deliver Level 2/Level 3 application support, managing incidents, problem resolution, and change requests under ITIL frameworks.

Perform routine maintenance including user access management, backup verifications, and system health checks.

Design and deliver end-user training programs to QC Microbiology and QA staff, maintaining updated SOPs, work instructions, and technical documentation.