Pharma CSV & Validation Specialist (ERP/MES)

Grünenthal Group; Origgio; On-site; EUR 34,000 - 35,000; Full time

Benefits offered by this job

Performance-based annual bonus

Job summary

Grünenthal Group in Lombardy (Origgio) seeks a dynamic professional for Manufacturing & Global Operations to support plant engineering, automation, and applications within a global, collaborative team.

You will help implement the digital roadmap, apply engineering standards, and drive operations excellence with focus on validated computerized systems, ERP (SAP) and KPI achievement. Fluent English and strong teamwork are required.

Qualifications

• University degree in Biotechnology, Engineering or related field.
• First experience or basic knowledge of validation/CSV in pharma/regulatory environment.
• Basic understanding of GMP, GAMP, data integrity and risk management.
• Knowledge of ERP systems and OPEX methodologies is a plus.
• Good communication and interpersonal skills.
• Fluent in English.

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 projects.
• Apply global engineering standards and best practices at manufacturing sites.
• Provide scientific engineering solutions focusing on operations excellence and KPI satisfaction.
• Take care of utilities/equipment/Computerized System Validation lifecycle (end-to-end).
• Assist in managing the inventory of computerized systems; evaluate risk and propose mitigations.
• Ensure top-level helpdesk for ERP (SAP), MES, and computerized systems of competence.

Skills

Communication skills

Interpersonal skills

Fluent English

GMP basics

GAMP basics

Data integrity

Risk management

ERP systems

OPEX methodologies

Education

University degree in Biotechnology, Engineering or a related scientific field

Tools

ERP systems

SAP

OPEX

Job description

Grünenthal Group in Lombardy (Origgio) seeks a dynamic professional for Manufacturing & Global Operations to support plant engineering, automation, and applications within a global, collaborative team.

You will help implement the digital roadmap, apply engineering standards, and drive operations excellence with focus on validated computerized systems, ERP (SAP) and KPI achievement. Fluent English and strong teamwork are required.