Qualification & CSV Specialist

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

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

• 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

• 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
• Fluent in English

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.