Qualification & Equipment Validation Expert

Experteer Italy; Origgio; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dynamic individual to join their Global Operations team. In this role, you will engage with internal and external customers to drive innovation while supporting the implementation of digital roadmaps and engineering projects. Your expertise in validation and risk management will be crucial as you apply global engineering standards to enhance manufacturing processes. This exciting opportunity allows you to contribute to the continuous improvement of high-quality products that make a real difference in patients' lives. If you thrive in a collaborative environment and are passionate about operational excellence, this position is perfect for you.

Competenze

• University degree in Biotechnologies or Engineering required.
• Minimum 2 years experience in validation in Pharma.

Mansioni

• Drive innovation through dynamic interaction with customers.
• Support digital roadmap implementation and engineering projects.

Conoscenze

Validation in Pharma

Risk Management

Data Management

Interpersonal Communication

Problem Solving

Formazione

University degree in Biotechnologies

University degree in Engineering

Strumenti

ERP systems (SAP)

Computerized Systems Validation

Descrizione del lavoro

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:

1. Dynamic interaction with internal and external customers to drive innovation
2. Be part of Global Operations multidisciplinary group dealing with plant engineering, automation and applications
3. Support digital roadmap implementation and engineering/production project
4. Application of global engineering standards, best practices to the manufacturing sites
5. Provide scientific engineering solutions to problems in Global Manufacturing with focus on operations excellence and KPI satisfaction
6. Taking care of utilities/equipment/computerized System Validation lifecycle (e2e)
7. Support in managing the inventory of computerized systems of the plant, undertake an evaluation of the risk and propose mitigations
8. 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:

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