Lab Systems Specialist — Data Integrity & CFR 21 Part 11

Lonza; Porriño; Presencial; Confidencial; Jornada completa

Descripción de la vacante

Lonza in Porriño, Spain seeks an experienced professional to lead the implementation and maintenance of laboratory systems within a regulated setting. You will oversee validation, upgrades, and data integrity, ensuring compliance with CFR 21 Part 11 and audit trails.

The role requires coordinating with Lab, Manufacturing, Engineering, Quality, and Maintenance teams and mentoring end users. You will also supervise contractors, manage CRs/CAPAs, and promote an EHS-focused culture, while acting as

Formación

• 3–5 years of experience in QC Systems, OT, IT, laboratory systems, or related areas.
• Experience with laboratory/QC systems, Data Integrity, and CFR 21 Part 11.
• Experience with system administration, troubleshooting, validation, and compliance in regulated environments.
• Strong problem-solving skills and a continuous improvement mindset.
• Excellent collaboration and communication skills.
• Ability to work with Laboratory/Manufacturing, Engineering, Quality and Maintenance teams.
• Native-level Spanish is required; business-fluent English preferred.

Responsabilidades

• Lead projects related to the implementation and modification of laboratory systems.
• Support qualification, implementation, maintenance, and upgrades of laboratory systems.
• Supervise contractors and external service providers, managing schedules, resources, and costs.
• Provide technical support and guidance to end users to use systems effectively.
• Ensure Data Integrity, audit trails, authorizations, permissions, and backups.
• 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.
• Promote a strong EHS and safety culture, supporting risk assessments and CAPA.

Conocimientos

OT/IT knowledge

QC Systems

Data Integrity

CFR 21 Part 11

Regulatory compliance

System administration

Troubleshooting

Cross-functional collaboration

Descripción del empleo

Lonza in Porriño, Spain seeks an experienced professional to lead the implementation and maintenance of laboratory systems within a regulated setting. You will oversee validation, upgrades, and data integrity, ensuring compliance with CFR 21 Part 11 and audit trails.

The role requires coordinating with Lab, Manufacturing, Engineering, Quality, and Maintenance teams and mentoring end users. You will also supervise contractors, manage CRs/CAPAs, and promote an EHS-focused culture, while acting as