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

Lonza; Lavamünd; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Competitive salary

Lifestyle benefits

Zusammenfassung

Lonza is seeking a CSV Engineer (m/f/d) to lead validation of computerized systems on process engineering equipment. The role requires site-based work to ensure high-quality and safe manufacturing of medicines.

You will prepare commissioning and validation docs, supervise deviations, and coordinate with internal/external teams. English proficiency is required; German is a plus. Relocation assistance is available for eligible candidates and families.

Qualifikationen

• Bachelor/Master/Diploma from technical school or university in a technical field or equivalent experience.
• Significant experience in a regulated environment with CSV.
• Knowledge of industry tools such as KNEAT, COMOS, DMS, TrackWise, SAP is an advantage.
• Proficient in English; German language skills are advantageous.

Aufgaben

• Prepare commissioning and validation documents for new systems and supervise conversions and expansions.
• Supervise deviations, changes (GEP and GMP), and CAPAs with strict protocol adherence.
• Coordinate CSV executions with internal groups and external providers.
• Present CSV documents during audits and inspections.
• Schedule and report CSV activities and maintain records.
• Align CSV strategy with QA CSV for Biologics scope and contribute to document improvements.

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