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

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Inclusive workplace

Competitive salary

Lifestyle and family benefits

Local Visp benefits

Zusammenfassung

Lonza in Visp, Switzerland is seeking a CSV Engineer (m/f/d) to lead the generation and execution of validation activities for computerized systems on process engineering equipment and facilities.

The role requires working on site to support real-time collaboration and precision in manufacturing medicines. You will coordinate CSV activities, audits, and improvements across projects and plant life cycles, with opportunities to contribute to QA alignment for biologics.

Qualifikationen

• Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
• Solid educational foundation in a technical field (Bachelor/Master/Diploma).
• Knowledge of industry software tools such as KNEAT, COMOS, DMS, TrackWise, SAP is advantageous.

Aufgaben

• Prepare commissioning and validation documents for new systems and supervise conversions, expansions, and new constructions including CSV activities for critical systems.
• Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict protocol adherence.
• Coordinate CSV executions with internal groups and external service providers to ensure seamless integration.
• Present CSV documents during audits and inspections to demonstrate high standards.
• Schedule and report CSV activities, maintaining a clear record of progress.
• Align CSV strategy with QA CSV for Biologics scope and contribute to ongoing optimization of CSV documents.
• Contribute to review and continual improvement of all CSV documents.

Kenntnisse

CSV validation experience

English proficiency

Ausbildung

Bachelor/Master/Diploma in technical field

Tools

KNEAT

COMOS

DMS

TrackWise

SAP

Jobbeschreibung

Switzerland, Visp

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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R78401