- Participate in GMP risk analysis for the manufacturing processes and Contamination Control Strategy of the facility
- Contribute to the development and implementation of standardized MSAT procedures and processes (e.g. qualification standard and strategy, single use system...)
- Partake in cross-functional teams as MSAT Expert tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale
- Support new product introduction by evaluating/developing 'fit for purpose' processes
- Take care of process monitoring and process control strategy as well as complex data analysis
- Own concepts on site or across the DPS network continuously improving in quality and efficiency in compliance to cGMPs, SOPs, EHS and applicable guidelines
- Lead Performance qualification activities for new equipment, filling line or a facility and support Process Performance Qualification of Biologics License Application projects
- Lead complex product and process related investigations and deviations including complaints actions and resolve technical challenges within area of expertise.
- Maintain processes at Inspection readiness level and to provide the necessary support in any internal or external audits as well as in Back/Front office or in facility tours
- University degree preferably in Biotechnology, Chemistry, Pharmacy, Engineering, Pharmaceutical Technology or equivalent scientific degree / equivalent experience
- Working experience in aseptic drug product manufacturing (clinical product and/or commercial product)
- Proven process and regulatory understanding in Sterile Manufacturing, cGMP and writing SOPs
- IT knowledge in SAP or MES is an asset
- Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor
- Experience in international inspection / audit is an asset
- Fluency in English, German is an asset
-
QA Manager Csv
vor 15 Stunden
Lonza Stein, SchweizSwitzerland, 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 h ...
-
Electrical Instrumentation Lead
vor 2 Tagen
Universal-Job Stein, Schweiz**Beschreibung** · Reports to: CAPEX Lead ADC Dolphin / Technical Project Manager -Support and Review of Design Documents related to their Discipline -Leads and Coordinates Sensor Risk Assessment according Project Standards -Ensures Swiss and Project Standards are kept. -Coordina ...
-
QA Manager 80-100%
vor 15 Stunden
Lonza Stein, SchweizSwitzerland, 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 h ...
-
Linienmechaniker Sterilproduktion 80-100%
vor 3 Stunden
Lonza Stein, SchweizLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentiert ...
-
Operator Abfüllung im 2-Schichtbetrieb 80-100%
vor 11 Stunden
Lonza Stein, SchweizLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentiert ...
-
Instandhaltungsmechaniker 80-100%
vor 11 Stunden
Lonza AG Stein, Schweiz NebenberuflichSwitzerland, Stein · Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche L ...
-
MES Specialist DPS Growth Project 80-100%
vor 11 Stunden
Lonza Stein, SchweizToday, 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 exc ...
-
QA Specialist Compliance
vor 11 Stunden
Lonza Stein, SchweizToday, 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 exc ...
-
Lonza Stein, SchweizToday, 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 exc ...
-
Lonza Stein, SchweizToday, 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 exc ...
-
Lonza Stein, Schweiz PraktikumSHIPStudent Internship in Pharmaceutical Manufacturing for 6 – 12 months · 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 wor ...
-
Cleaning Validation Expert
vor 11 Stunden
Lonza Stein, SchweizCleaning Validation Expert · Location – Stein, Switzerland · 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 togethe ...
-
Process Expert Logistics
vor 1 Tag
Lonza Stein, SchweizToday, 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 exc ...
-
QA Expert Manufacturing Release 80-100%
vor 11 Stunden
Lonza Stein, SchweizSenior QA Expert Manufacturing Release 80-100% · Location – Stein, Switzerland · 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 ...
-
QA Expert Equipment Qualification and Validation, CSV
vor 11 Stunden
Lonza Stein, SchweizToday, 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 exc ...
-
Automation Engineer 80-100%
vor 1 Tag
Lonza Stein, SchweizLocated in our successful CDMO Business Unit currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Automation (Senior) Engineer 80-100% su ...
-
Automation Engineer 80-100%
vor 15 Stunden
Lonza Stein, SchweizToday, 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 exc ...
-
QA Specialist Compliance
vor 1 Woche
Lonza AG Stein, Schweiz GanztagsSwitzerland, Stein · 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 t ...
-
Supply Planner DPS Growth Project 80-100%
vor 2 Tagen
Lonza AG Stein, Schweiz NebenberuflichSwitzerland, Stein · 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 t ...
-
Automation Engineer HVAC-Utilities 80
vor 2 Tagen
Lonza AG Stein, Schweiz NebenberuflichSwitzerland, Stein · 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 t ...
MSAT Expert Drug Product 80 - Stein, Schweiz - Lonza
Beschreibung
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.
Located in our successful CDMO Business Unit currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and apply for the position as MSAT Expert where you will be responsible for successful drug product and manufacturing process transfers as well as implementation at the manufacturing site. Join us to lead projects to improve and expand manufacturing capabilities across our DPS network.
Key Responsibilities:
Key requirements:
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: R57453