Associate Director Operation Readiness Lead (m/w/d) (80-100%)

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.

We are hiring for a driven Associate Director Operation Readiness Lead to ensure that new equipment, facilities, and processes meet the regulatory requirements and quality standards. You will be responsible for the preparation, design and execution of all CQV activities, within safety, schedule, quality and functionality in the investment Project.

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

• Responsible for managing and leading a team of engineers, operation and technicians to develop and execute CQV protocols for new equipment, facilities, and processes in compliance with regulatory requirements and quality standards.

• Oversee the execution of qualification and validation activities, such as installation, operational, and performance qualification, and ensure that all documentation and reports are accurate and complete.

• Collaborate with other departments, such as engineering, manufacturing, quality, and regulatory affairs, to ensure that CQV activities are integrated into the project plan and completed on time and within budget

• Calculate resource allocation, cost estimation, and timeline projection for successful CQV execution in assigned portfolio of CAPEX projects, ensuring the completion of all tasks within schedule through daily meetings with team members and resources to highlight and communicate schedule targets, resolve issues, and escalate when necessary.

• Act as subject matter expert (SME) in developing Project Execution Plan and Project Quality Plan and involved committees.

• Develop and implement commissioning, qualification, and validation (CQV) strategies aligned with global standards for CAPEX investments portfolio.

• Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments.

Ihre Hauptaufgaben

• Verantwortlich für die Führung eines Teams aus Ingenieuren, Betriebs- und Technikern zur Entwicklung und Durchführung von CQV-Protokollen für neue Anlagen, Einrichtungen und Prozesse gemäß regulatorischer Anforderungen und Qualitätsstandards.

• Überwachung der Durchführung von Qualifizierungs- und Validierungsaktivitäten wie Installations-, Betriebs- und Leistungsqualifizierung sowie Sicherstellung der Genauigkeit und Vollständigkeit aller Dokumentationen und Berichte.

• Zusammenarbeit mit anderen Abteilungen wie Engineering, Fertigung, Qualitätssicherung und Zulassung, um die Integration der CQV-Aktivitäten in den Projektplan und deren termingerechte und budgetkonforme Fertigstellung zu gewährleisten.

• Berechnung der Ressourcenzuweisung, Kostenschätzung und Zeitplanung für die erfolgreiche CQV-Durchführung im zugewiesenen Portfolio von Investitionsprojekten. Sicherstellung der termingerechten Fertigstellung aller Aufgaben durch tägliche Meetings mit Teammitgliedern und Ressourcen, um Terminziele zu kommunizieren, Probleme zu lösen und bei Bedarf zu eskalieren.

• Fachliche Beratung bei der Entwicklung des Projektdurchführungsplans und des Projektqualitätsplans sowie der beteiligten Gremien.

• Entwicklung und Implementierung von CQV-Strategien (Inbetriebnahme, Qualifizierung und Validierung) gemäß globalen Standards für das Investitionsportfolio.

• Zusammenarbeit mit funktionsübergreifenden Teams zur Identifizierung und Minderung von Risiken im Zusammenhang mit CAPEX-Investitionen.

What we are looking for

• Master Degree or equivalent experience in Pharma, Engineering, or Science

• Proven experience in Pharma / Engineering (GEP/GMP) with an understanding of Small Molecules, Infrastructure and Laboratories business

• Proven experience in Project Management, CQV

• Understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGM

• Strong leadership skills with a global interaction capability.

• Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk.

• Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions.

• Can develop and implement new and standard processes, tools/methodologies in a global context, lead and train/support colleagues.

• 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.