Overview
In this role you lead and optimize laboratory systems projects, supporting qualification, implementation, maintenance, and upgrades. You will guide end users, ensure data integrity and compliant access, and manage change requests and CAPAs. You collaborate across Laboratory, Engineering, Quality and Maintenance teams to standardize procedures and promote a strong safety culture. This position offers impact by shaping how systems enable compliant science and reliable operations in a integral life sciences context.
Responsabilidades
- Lead projects for 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
- Maintain data integrity, audit trails, authorizations, permissions, and backup processes
- Manage Change Requests (CRs) and CAPAs related to laboratory operation systems
- Troubleshoot system issues and collaborate with manufacturers and providers
- Act as SME for Data Integrity and CFR 21 Part 11
- Contribute to standardization of procedures across laboratory systems
- Promote EHS/safety culture and support risk assessments and CAPA implementation
Requisitos principales
- 3–5 years in QC systems, OT/IT, or related areas
- Experience with laboratory/QC systems, Data Integrity, and CFR 21 Part 11
- System administration, troubleshooting, validation, and compliance in regulated environments
- Strong problem-solving and continuous improvement mindset
- Excellent collaboration and communication skills
- Ability to work with Laboratory/Manufacturing, Engineering, Quality and Maintenance teams
- Strong organizational and time-management skills
- Native-level Spanish; business-fluent English preferred
- collaboration
- communication
- problem-solving
- OT/IT knowledge
- QC systems
- Data Integrity
📌 Operations Laboratory Systems Specialist (Porriño)
🏢 Lonza
📍 Porriño