Qualification & CSV Specialist

Gr?nenthal GmbH; Varese; Hybrid; EUR 34,000 - 35,000; Full time

Job summary

Grünenthal GmbH is recruiting for a full-time on-site role in Global Operations & Production. The position offers a competitive pay range and a structured path in manufacturing excellence, with a focus on validation, automation, and digital roadmap delivery.

You will engage with internal and external customers, join a multidisciplinary operations team, and contribute to ERP/MES systems support and KPI-driven improvements across the value chain.

Qualifications

• Bachelor or Master in biotech/engineering or related field.
• First experience or basic knowledge of validation/CSV in pharma.
• Understanding GMP, GAMP, data integrity and risk management.
• Familiarity with ERP tools and problem-solving methods.

Responsibilities

• Interact with internal and external customers to drive innovation.
• Work within Global Operations multidisciplinary group on 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.
• Oversee validation lifecycle of utilities/equipment/Computerized Systems (E2E).
• Help manage the plant's computerized system inventory and assess risk with mitigations.
• Ensure top-level helpdesk support for ERP (SAP), MES, and computerized systems.

Skills

GMP basics

GAMP

Data integrity

Risk management

Education

University degree in Biotechnology/Engineering

Tools

ERP systems

SAP

Job description

Department: Global Operations & Production

Job ID: 45507

Pay Range (full-time): EUR 34.000 35.000

Professional|Permanent|Full-time|On-Site

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 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

Our pay ranges are based on an objective, gender-neutral job evaluation system. The final salary offered is determined based on factors like, but not limited to, relevant education, skills, experience, certifications, geographic location, and business or organizational needs. Your compensation package will include a performance-based annual bonus.

Grünenthal offers equal employment opportunities. Recruitment will take place without distinction with regard to religion, gender, sexual orientation, age, origin, disability or other relevant categories.

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned 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 focussing 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 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.