Operations Laboratory Systems Specialist (f/m/d)

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

Spain, Porriño

Location. Porriño, Pontevedra.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

What You’ll Do

• 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 is delivered while maintaining control over schedules, resource allocation, and associated 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 and application providers to resolve problems.
• Act as a Subject Matter Expert (SME) for Data Integrity and CFR 21 Part 11 requirements.
• Contribute to the standardization of procedures and practices across laboratory systems.
• Promote a strong EHS and safety culture, supporting risk assessments, investigations, and CAPA implementation.

What We’re Looking For

• 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 in laboratory/QC systems, Data Integrity, and CFR 21 Part 11.
• Experience with system administration, troubleshooting, validation, and compliance in a regulated environment.
• Strong problem-solving skills and a continuous improvement mindset.
• Excellent collaboration and communication skills.
• Ability to work effectively with Laboratory/Manufacturing, Engineering, Quality and Maintenance teams.
• Strong organizational and time-management skills, with the ability to manage multiple priorities.
• We are looking for a proactive, customer-focused individual with a strong sense of ownership, accountability, and a positive attitude towards work and teamwork.
• Native-level Spanish is required.
• Business-fluent English is preferred.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R79614