Experteer Overview

Para presentar una candidatura, simplemente lea la siguiente descripción del puesto y asegúrese de adjuntar los documentos pertinentes.
In this role you lead and optimize laboratory system projects across QC and OT environments, shaping how data flows and is controlled in a regulated setting. You will partner with cross-functional teams to maintain data integrity, ensure compliance, and drive system improvements. You’ll serve as a SME for CFR 21 Part 11 and data integrity, influencing standard practices and risk-focused CAPA activities. This is a chance to contribute to lifesaving work while advancing a career in laboratory IT/OT governance.

Compensaciones / Ventajas
• Lead projects for implementing and modifying laboratory systems
• Support qualification, implementation, maintenance, and upgrades of lab systems
• Supervise contractors and external providers, managing schedules, resources, and costs
• Provide technical support and user guidance to optimize system use
• Maintain Data Integrity, audit trails, authorizations, permissions, and backups




• Manage Change Requests (CRs) and CAPAs for laboratory operation systems
• Troubleshoot system issues and coordinate with manufacturers/providers to resolve them
• Act as SME for Data Integrity and CFR 21 Part 11 requirements
• Contribute to standardization of procedures across lab systems
• Promote strong EHS and safety culture, supporting risk assessments and CAPA implementation

Responsabilidades
• Proven working knowledge in OT/IT with experience in QC Systems and OT environments
• 3-5 years of relevant experience in QC Systems, OT, IT, or related areas
• Experience in laboratory/QC systems, Data Integrity, and CFR 21 Part 11
• Experience with system administration, xghoner troubleshooting, validation, and compliance in a regulated environment
• Strong problem-solving and continuous improvement mindset
• Excellent collaboration and communication skills
• Ability to work with Laboratory/Manufactu

📌 Operations Laboratory Systems Specialist (Porriño)
🏢 Lonza
📍 Porriño