Qualification, Equipment Validation & CSV Expert

Grunenthal

Industria farmaceutica

21040 Origgio, Lombardia - Italien

Specialista Senior / Project Manager

Experteer Overview

In this role you support Global Operations to enhance manufacturing quality and efficiency across the value chain. You will contribute to plant engineering, automation, and applications while driving digital roadmap initiatives. You’ll apply global engineering standards and deliver scientific engineering solutions to improve operations and KPI performance. You manage validated computerized systems lifecycle and risk, and you serve as a technical partner across ERP/MES domains, collaborating with internal and external customers to drive innovation. This position offers impact in a global, collaborative environment focused on quality and continuous improvement.

Responsabilità

Part of Global Operations multidisciplinary group handling plant engineering, automation and applications
Support digital roadmap implementation and engineering/production projects
Apply global engineering standards and best practices at manufacturing sites
Provide scientific engineering solutions focusing on operations excellence and KPI satisfaction
Manage the validation lifecycle for utilities/equipment/computerized systems (end-to-end)
Support inventory management of plant computerized systems and perform risk assessments with mitigations
Ensure top-level helpdesk support for ERP (SAP), MES, serialization, and other computerized systems
Interact with internal/external customers to drive innovation

Requisiti fondamentali

University degree in Biotechnologies, Engineering, IT or comparable
Minimum 3 years' experience with validation/CSV in Pharma or similar
Experience in a coordination role (project manager, coordinator, team leader) is beneficial
Knowledge of validation techniques (GMP; GAMP; WHO, CFR21…) and risk management
Experience with data management and data integrity concepts
OPEX problem solving knowledge beneficial
Interpersonal understanding, communication skills and leadership attitude
Fluency in business English

interpersonal understanding communication skills leadership attitude validation techniques (GMP, GAMP, WHO, CFR21)CSV in pharma risk management

Descrizione della posizione

In this role you support Global Operations to enhance manufacturing quality and efficiency across the value chain. You will contribute to pl…

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