CQV / Qualification and Validation Specialist (f/m/d)

vor 2 Monaten

Visp, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a CQV Specialist (m/f/d) in , you are responsible for the qualification and validation of process engineering equipment and facilities. You are responsible for the professional planning and implementation of qualification and validation activities resulting from projects and system adjustments during the system life cycle. You make a significant contribution to the ongoing optimization of processes, systems and internal procedures. You are jointly responsible for ensuring that the plant personnel and the engineering groups have the necessary technical knowledge.

Key Responsibilities:

Creation of commissioning and qualification documents for new plants, as well as the supervision of conversion, expansion and new construction projects. This is broken down into PQs on new construction projects for critical systems and the SLC support of all systems after going live

Supervision of deviations, changes (GEP and GMP), as well as CAPAs

Coordination of internal groups as well as external service providers and suppliers

Responsible for the presentation of the qualification documents during audits and inspections

Key requirements:

Graduate from a technical school (HF) / university of applied sciences (FH) or university degree or equivalent work experience 

Good experience in a regulated environment GMP with regard to commissioning, qualification and validation, e.g. refrigerators and freezers, clean media and rooms, as well as process engineering equipment

Good knowledge of MS Office is required, knowledge of COMOS (plant engineering software solution), DMS, Kneat, TrackWise and SAP is an advantage

Fluent German (written and spoken) and/or fluent English (written and spoken)

Independent and flexible work with a good communication style, also structured, focused and well-organized work behavior and also open to new ideas, agile and proactive

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R46721

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