Qualification and Good Engineering Practices Specialist

Gr?nenthal GmbH; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Qualification & Equipment Validation Expert to join their Global Operations team in Milan. In this role, you will tackle challenges involving engineering standards, support digital roadmaps, and ensure operational excellence. The ideal candidate will possess a degree in Biotechnologies or Engineering and have relevant experience in validation and risk management. Join the team to help innovate and enhance product quality in a collaborative environment.

Competenze

• At least 2 years' experience with validation, CSV in Pharma.
• Knowledge of validation techniques (GMP; GAMP; WHO, CFR21).

Mansioni

• Drive innovation through customer interactions.
• Apply global engineering standards in manufacturing.
• Manage utilities and computerized system validation lifecycle.

Conoscenze

Interpersonal understanding

Communication skills

Risk management

Data management

Data integrity

OPEX problem solving techniques

Fluency in business English

Formazione

University degree in Biotechnologies or Engineering

Strumenti

ERP systems (e.g. SAP)

Computerized Systems Validation

Descrizione del lavoro

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Qualification & Equipment Validation Expert

Department : Global Operations & Production

Job ID : 44524

Our people in Manufacturing & Global Operations share two priorities : getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

Each day you'll enjoy a variety of challenges, such as :

• 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

What you'll bring to the table

To make the most of this role and truly thrive, you should have :

• University degree Biotechnologies, Engineering or comparable
• Experienced with validation, CSV in Pharma or comparable (at least 2 years)
• Risk management, data management, data integrity knowledges
• Knowledge of ERP system is beneficial
• Knowledge of validation techniques (GMP; GAMP; WHO, CFR21…)
• OPEX problem solving techniques is beneficial
• Interpersonal understanding and communication skills
• Fluency in business English

Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of € 1.8bn.

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