Associate Director, Ge Commissioning and Qualification
Vor 3 Tagen
**Switzerland, Stein** 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 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 an outstanding opportunity to contribute to innovative CQ projects in Switzerland **Key responsibilities**: - Responsible for handling and leading a team of CQ experts. - Oversee the generation of all protocols for several projects such as life cycle documents. - 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 offices which will be located in different strategic locations across the globe to increase efficiency and to reduce cost. - Be in charge to assess the capability and capacity of all suppliers quality department to ensure delivery of proper documentation in timely manner. - Collaborate with the different CQ Portfolio leads to ensure alignment on the documentation across all VISP projects. - Lead CQV activities to ensure compliance with regulatory requirements and industry standards. - 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 or equivalent experience in Pharma, Engineering, or Science - Proven experience in Pharma / Engineering (GEP/GMP) with an understanding of Fill and Finish Facility Building and processes. - Proven experience in Project Management, CQV - Proficient in English, German is an advantage - 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. **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. Reference: R68574
-
Lead Commissioning
vor 2 Wochen
Stein (AR), Schweiz ITech Consult AG VollzeitLead Commissioning & Qualification Engineer - CQ/GMP/CQV-Lead/Pharmaceutical Project: We are actively seeking a dedicated Lead Commissioning & Qualification Engineer professional to join our client's team. This pivotal role involves overseeing and executing commissioning and qualification processes within a dynamic pharmaceutical environment. Your expertise...
-
Global Commissioning
Vor 3 Tagen
Stein, Schweiz Lonza VollzeitA Career at Lonza **What you’ll get** - An agile career and a dynamic work culture - An inclusive and ethical workplace - Compensation programs that recognize high performance 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...
-
Associate Director
Vor 3 Tagen
Stein, Schweiz Lonza Vollzeit**Switzerland, Stein** **Location**:Stein AG (Switzerland) 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...
-
Associate Director
Vor 2 Tagen
Stein, Schweiz Lonza Vollzeit**Location**:Stein AG (Switzerland) 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...
-
C&Q Coordinator
Vor 7 Tagen
Stein, Schweiz Lonza VollzeitJob Description The CQ Coordinator reports to the Project CQV Manager and is responsible for supporting the planning, execution, and supervision of Commissioning and Qualification field activities. The role ensures compliance with the URS, GMP, Safety and Environmental objectives and all relevant site/local and global procedures. Coordinating the planning...
-
QA Teamlead Qualification and Validation 80-100%
vor 2 Wochen
Stein, Schweiz Lonza VollzeitSwitzerland, SteinToday, 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...
-
QA Specialist
vor 1 Woche
Stein, Schweiz Proclinical VollzeitSafeguard quality, shape compliance, and power the future of aseptic manufacturing. Join one of Proclinical's clients as a Quality Assurance Specialist and help safeguard the integrity of aseptic manufacturing. In this role, you'll drive compliance for equipment and computerized systems, ensuring GMP processes meet the highest standards. As part of major...
-
CQV Field Coordinator
Vor 7 Tagen
Stein, Schweiz Lonza VollzeitA leading pharmaceutical company in Stein, Aargau is seeking a CQ Coordinator for contract employment. This role involves coordinating commissioning and qualification activities, ensuring compliance with safety and quality standards, and managing the commissioning team. The ideal candidate has experience in biopharma engineering, strong analytical and...
-
Junior Qualification and Audit Support Expert
vor 1 Woche
Stein, Schweiz D-ploy VollzeitD-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT...
-
Junior Qualification and Audit Support Expert
vor 1 Woche
Stein, Schweiz D-ploy VollzeitD-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT...