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Operations Laboratory Systems Specialist (f/m/d)

lonza · Porriño

Nuevo
Mid 🇬🇧 English
OT/IT QC Systems Data Integrity CFR 21 Part 11 Change Requests CAPA Validation

Descripcion del puesto

About the role

Lonza, a global life sciences company, is hiring an Operations Laboratory Systems Specialist in Porriño, Pontevedra. The role covers the implementation, maintenance and upgrades of laboratory systems, supervising contractors and providing technical support to end users, while acting as a subject matter expert on data integrity and CFR 21 Part 11.

Key responsibilities

  • Lead projects for implementing and modifying laboratory systems.
  • Support qualification, implementation, maintenance and upgrade of laboratory systems.
  • Supervise contractors and external service providers, keeping schedules, resources and costs under control.
  • Provide technical support and guidance to end users.
  • Ensure Data Integrity, audit trails, authorizations, permissions and backups are maintained.
  • Manage Change Requests (CRs) and CAPAs related to laboratory systems.
  • Troubleshoot system issues and work with manufacturers and application providers to resolve them.
  • Act as SME for Data Integrity and CFR 21 Part 11, and contribute to standardizing procedures across laboratory systems.
  • Promote a strong EHS and safety culture, supporting risk assessments, investigations and CAPA implementation.

Required profile

  • 3-5 years of relevant experience in QC systems, OT, IT, laboratory systems or a related area.
  • Experience with laboratory/QC systems, Data Integrity and CFR 21 Part 11.
  • Experience with system administration, troubleshooting, validation and compliance in a regulated environment.
  • Native-level Spanish is required; business-fluent English is preferred.
  • Strong problem-solving, collaboration, communication, organizational and time-management skills, with a proactive, customer-focused approach.

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Source : ats:workday

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