Lab Systems Lead (OT/IT) – Data Integrity & CFR 21 Part 11

Lonza Group Ltd.; Porriño; Presencial; EUR 42.000 - 65.000; Jornada completa

Descripción de la vacante

Lonza Group Ltd. in Galicia, Spain seeks an OT/IT professional with 3–5 years of experience in QC laboratory systems. The role focuses on implementing and maintaining laboratory systems, ensuring data integrity and CFR 21 Part 11 compliance, and directing contractors to meet project timelines.

Spanish is native and English is preferred for global collaboration. You will lead IT/OT initiatives, support system upgrades, and ensure validated, compliant environments across manufacturing and QC

Formación

• Proven working knowledge in OT/IT, ideally with experience in QC Systems and OT environments.
• 3–5 years of relevant experience in QC Systems, OT, IT, laboratory systems, or a related area.
• Experience with system administration, troubleshooting, validation, and compliance in a regulated environment.
• Experience with Data Integrity and CFR 21 Part 11.

Responsabilidades

• Lead projects related to the implementation and modification of laboratory systems.
• Support the qualification, implementation, maintenance, and upgrade of laboratory systems.
• Supervise contractors and external service providers, ensuring adequate support and control over schedules and costs.
• Provide technical support and guidance to end users, helping them use systems effectively.
• Ensure Data Integrity, audit trails, authorizations, permissions, and backup processes are maintained.
• Manage Change Requests (CRs) and CAPAs related to laboratory operation systems.
• Troubleshoot system issues and collaborate with manufacturers to resolve problems.
• Act as SME for Data Integrity and CFR 21 Part 11 requirements.
• Contribute to standardization of procedures across laboratory systems.

Conocimientos

OT/IT knowledge

QC Systems experience

Data Integrity

System administration

Troubleshooting

Cross-functional collaboration

Spanish (native)

English (business fluent)

Descripción del empleo

Lonza Group Ltd. in Galicia, Spain seeks an OT/IT professional with 3–5 years of experience in QC laboratory systems. The role focuses on implementing and maintaining laboratory systems, ensuring data integrity and CFR 21 Part 11 compliance, and directing contractors to meet project timelines.

Spanish is native and English is preferred for global collaboration. You will lead IT/OT initiatives, support system upgrades, and ensure validated, compliant environments across manufacturing and QC