Associate Director, Ge Commissioning
Vor 4 Tagen
We are hiring for a driven Global Engineering CQ Lead Shared Function (Commissioning, Qualification). In this role you will ensure that services and processes meet the regulatory requirements and quality standards.
Join our ambitious team and help deliver world-class engineering projects. This is anoutstanding opportunity to contribute to innovative CQ project in Switzerland
The role is based in Visp, Switzerland. Relocationassistance is available for eligible candidates and their families, if needed. The roles requires to be onsite full time.
Key responsibilities:
Responsible for handling and leading a team of CQ expert.
Oversee the generation of all protocol for several project such as life cycle document.
Commissioning and qualification plan and report.
Oversee the alignment and execution of the IV/IQ static testing across all site projects.
The GE CQ Lead shared function will mainly support all the CQ Portfolio lead but also collaborates with other departments, such as engineering, manufacturing, quality, procurement and regulatory affairs, to ensure that CQ activities are increasing on efficiency regarding Cost and Timeline.
Oversee several remote office which will be located in different strategic location across the globe to increase efficiency and to reduce Cost. ·
Be in charge to assess the capability and capacity of all supplier quality department to ensure delivery of proper documentation in timely manner.
Collaborate with the different CQ Portfolio lead to ensure alignment on the documentation across all VISP project.
Lead CQV activities to ensure compliance with regulatory requirements and industry standards.
Collaborate with the different CQ Portfolio lead to ensure capacity of resources for Document generation and Static qualification activities such as IV/IQ.
Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments.
Provide technical leadership and guidance for CQV activities according to industry standards.
Develop and maintain relationships with key stakeholders for successful project execution.
Key requirements:
Master Degree orequivalentexperienceinPharma, Engineering, or Science
ProvenexperienceinPharma / Engineering (GEP/GMP)
Provenexperiencein Project Management, CQV
Proficient in English, German is an advantage
Understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP.
Understanding of Small Molecules, Infrastructure and Laboratories business
Strong leadershipskills 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.
Experience in calculating project-related resource needs, time, and costs.
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.
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 newideasinlifesciences. In return, we offer thesatisfactionthatcomeswithimproving lives all around the world. Thesatisfactionthatcomeswith making ameaningfuldifference.
Inclusion is one of Lonza's four core values, alongside integrity, innovation, and initiative. We understand thevalueof our differences and the benefits they bring to our company, community, and culture. We also recognize thevalueof every person's contribution, regardless of characteristics, preferences, and beliefs – including race, color, ethnicity, sexual orientation, gender identity, and religion.
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