Data Integrity QA Lead — MES/BMS & CSV Expert

Lonza Group Ltd.

Stein

Hybrid

Confidential

Full time

8 days ago

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Job summary

Lonza Group Ltd. in Stein, Switzerland seeks a Data Integrity Ambassador to lead DI assessments, drive compliance, and validate computerized systems for MES (MODA) and BMS (DeltaV). The role emphasizes collaboration with global teams to ensure inspection-ready systems throughout their lifecycle.

You will oversee validation activities for equipment, infrastructure, and CAPEX projects, and act as the QA lead for CSV strategies and risk assessments in a highly regulated manufacturing setting.

Qualifications

Proven experience in Quality Assurance within GMP environments.
Hands-on expertise in Computerized System Validation (CSV).
Experience validating MES, BMS and automation systems such as MODA, DeltaV.
Ability to manage deviations, changes and quality risk assessments.

Responsibilities

Serve as the Data Integrity (DI) Ambassador for the Stein site, leading DI assessments and driving compliance initiatives.
Lead CSV activities for MES (MODA) and BMS (DeltaV) including lifecycle management.
Oversee system validation for equipment/infrastructure for routine activities and CAPEX projects.
Act as the QA contact for CSV, guiding validation strategies and document lifecycle management.
Partner with global teams to drive continuous improvement and support audits and deviations.

Skills

QA & GMP

CSV expertise

MES/DeltaV/MODA

Deviation handling

English fluency

Tools

MODA

DeltaV

BMS

Job description

You will oversee validation activities for equipment, infrastructure, and CAPEX projects, and act as the QA lead for CSV strategies and risk assessments in a highly regulated manufacturing setting.

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