Qualification CQV Engineer (m/w/d) (80-100%)

Reposted 2 Days Ago
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Visp, Valais
In-Office
Mid level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
As a CQV Engineer, you will manage system qualifications, support Capex projects, and ensure compliance with GMP standards in the pharmaceutical sector.
Summary Generated by Built In

 

What you will get

  • An agile career and a dynamic work 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. The full list of our local tailored benefits can also be found below.

  • Benefits in Visp: https://bit.ly/3wjkoFi

Today, Lonza is a global leader in life sciences operating across five 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 CQV Engineer in the ADS Platform, Small Molecules you will manage existing systems in terms of qualification and supports investment projects, commissioning, and start-up activities in all aspects. You will also be responsible for the commissioning of current and future investment projects as well as the planning, coordination, execution, and documentation of all project-related qualification activities.

The role is based in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This role involves being onsite full time.

What you will do

  • Asset life cycle management of existing systems with regard to qualification

  • Responsible for system qualification for new constructions, system expansions, and optimization of existing systems prior to GMP production

  • Responsible for coordinating technical change management

  • Support the qualification lead in all matters

  • Support Capex projects and the engineering team throughout various project phases as a member of the project organization

  • Coordinate interfaces and act as a link between engineering, commissioning, and qualification

  • Present and represent qualification during audits and inspections

  • Content review and completion of qualification activities performed

Ihre Hauptaufgaben

  • Asset Life Cycle Management von bestehenden Anlagen in Bezug auf Qualifizierung

  • Verantwortlich für Anlagenqualifizierung bei Neubauten / Anlageerweiterungen / Optimierung bestehender Anlagen vor einer GMP-Produktion

  • Zuständig für die Koordination des technischen Änderungswesens

  • Unterstützung des Qualifizierungsleiters in allen Belangen

  • Unterstützt Capex Projekte und das Engineering team in den verschiedenen Projektphasen als Mitglied der Projektorganisation

  • Koordiniert die Schnittstellen und agiert als Bindeglied zwischen Engineering, Inbetriebnahme / Qualifizierung

  • Vorstellen und vertreten der Qualifizierung während Audits und Inspektionen

  • Inhaltliche Kontrolle und Abschluss der durchgeführten Qualifizierungsarbeiten

What we are looking for

  • BSc or completed technical education in the field of mechanical, plant engineering, EMR or related field with several years of experience in process engineering, production, or a similar field

  • Ideally, good knowledge/experience in GMP

  • Several years of experience in active pharmaceutical ingredient (API) manufacturing in the chemical/pharmaceutical sector under GMP

  • Several years of experience in qualification

  • Enjoyment in creating and maintaining qualification documentation, which requires high standards of accuracy and cleanliness

  • Very good PC skills (MS Office / SAP / DMS / COMOS)

  • Fluent in German and English. Alternatively, you are fluent in one of the two languages and willing to learn the other.

Why Lonza ?

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.

Inclusion is one of Lonza’s four core values, alongside integrity, innovation, and initiative. We understand the value of our differences and the benefits they bring to our company, community, and culture. We also recognize the value of every person’s contribution, regardless of characteristics, preferences, and beliefs – including race, color, ethnicity, sexual orientation, gender identity, and religion.

Top Skills

Comos
Dms
MS Office
SAP
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The Company
HQ: Basel
0 Employees
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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