CSV Engineer Biologics 80-100% (m/f/d)

Lonza Group Ltd.; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Performance bonuses

Lifestyle benefits

Visp benefits list

Zusammenfassung

Lonza Group Ltd. is seeking a CSV Engineer (m/f/d) to generate and execute validation of computerized systems on process equipment and facilities at our Visp site in Switzerland. The role focuses on commissioning, validation, and project support across lifecycle stages.

You will coordinate CSV activities, supervise deviations and CAPAs, and present documents during audits. Proficiency in English is required and German is a plus; relocation assistance is available for eligible candidates.

Qualifikationen

• Solid educational foundation in a technical field.
• Significant experience in a regulated environment with CSV.
• Proficiency in English; German language skills advantageous.

Aufgaben

• Prepare commissioning and validation documents for new systems, and supervise conversion, expansion, and new construction projects.
• CSV activities for critical systems in new construction projects and post-debut life-cycle support.
• Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict adherence to protocols.
• Coordinate CSV executions with internal groups and external service providers to ensure seamless integration.
• Present CSV documents during audits and inspections, demonstrating high standards.
• Schedule and report CSV activities, maintaining a flawless progress record.
• Align CSV strategy with QA CSV for Biologics scope.
• Contribute to review and continuous improvement of all CSV documents.

Kenntnisse

CSV validation experience

English proficiency

GxP knowledge

Project coordination

Ausbildung

Bachelor/Master in technical field

Tools

KNEAT

COMOS

DMS

TrackWise

SAP

Jobbeschreibung

Relocation assistance is available for eligible candidates and their families, if needed.

As a CSV Engineer (m/f/d) you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities.

You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as make a contribution to the ongoing optimization of processes, facilities and internal procedures.

This role is primarily based on site. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you’ll get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.
• Our full list of tailored local benefits in Visp can be found on Benefits - Visp

What you will do:

• Prepare commissioning and validation documents for new systems, and supervise conversion, expansion, and new construction projects.
• This includes CSV activities for critical systems in new construction projects and SLC support for all systems post debut.
• Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict adherence to protocols.
• Coordinate CSV executions with internal groups, as well as external service providers and suppliers, to strictly ensure seamless integration.
• Present CSV documents during audits and inspections, showcasing our world-class standards.
• Schedule and report CSV activities, maintaining a flawless record of progress and outcomes.
• Align CSV strategy with QA CSV for all Biologics scope, showcasing our dedication to high standards.
• Contribute to the review and continuous amelioration of all CSV documents, ensuring ongoing optimization and success.

What we are looking for:

• Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field or equivalent experience, showcasing your solid educational foundation.
• Significant experience in a regulated environment with regard to Computerized System Validation (CSV), demonstrating your proven expertise.
• Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise, and SAP is an advantage, improving your ability to compete in our ambitious environment.
• Proficient in English, with German language skills being advantageous, enabling you to collaborate effectively in our diverse team.

About Lonza:

At Lonza, our people are our greatest strength. Spread across 30+ sites and five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity shape what we achieve and how we achieve it. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

Ready to shape the future of life sciences?