CSV & Qualification Specialist – Pharma Ops & ERP

Gr?nenthal GmbH; Origgio; On-site; EUR 34,000 - 35,000; Full time

Benefits offered by this job

Performance-based bonus

Equal employment opportunities

Job summary

Grünenthal GmbH in Lombardy is seeking a Manufacturing & Global Operations professional to join our on-site team in Origgio. The role emphasizes validation/CSV, GMP awareness and ERP/MES excellence to support our production and plant engineering activities.

You will engage with internal and external customers, contribute to the digital roadmap, ensure ERP/MES/computerized system validation, and help manage KPI-driven operations while aiming for world-class quality across the value chain.

Qualifications

• University degree in Biotechnology, Engineering or a related scientific field.
• First experience or basic knowledge of validation/CSV in a pharmaceutical or regulated environment.
• Basic understanding of GMP, GAMP, data integrity and risk management principles.
• Knowledge of ERP systems and OPEX/problem-solving methodologies is a plus.
• Good communication and interpersonal skills.

Responsibilities

• Dynamic interaction with internal and external customers to drive innovation.
• Be part of Global Operations multidisciplinary group dealing with plant engineering, automation and applications.
• Support digital roadmap implementation and engineering/production project.
• Application of global engineering standards, best practices to the manufacturing sites.
• Provide scientific engineering solutions to problems in Global Manufacturing with focus on operations excellence and KPI satisfaction.
• Taking care of utilities/equipment/Computerized System Validation lifecycle (e2e).
• Support in managing the inventory of computerized systems of the plant, undertake an evaluation of the risk and propose mitigations.
• Ensure top-level helpdesk of ERP (i.e. SAP), MES, serialisation and/or computerized systems of competence

Skills

Communication skills

Problem-solving

Interpersonal skills

GMP knowledge

Education

University degree in Biotechnology, Engineering or related field

Tools

SAP

MES

Job description

Grünenthal GmbH in Lombardy is seeking a Manufacturing & Global Operations professional to join our on-site team in Origgio. The role emphasizes validation/CSV, GMP awareness and ERP/MES excellence to support our production and plant engineering activities.

You will engage with internal and external customers, contribute to the digital roadmap, ensure ERP/MES/computerized system validation, and help manage KPI-driven operations while aiming for world-class quality across the value chain.