Quality Control Associate I Microbiology
Gefunden in: beBee S CH - vor 3 Wochen
About This Role
The main responsibilities for the Quality Control Associate I Microbiology includes execution of all the Microbiology related testing activities at Biogen’s large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include microbiological identification, bacterial endotoxin test (KCA and KTA), detection of microorganisms (BacT/Alert), growth promotion test and microbial enumeration test. In addition, the Quality Control Associate will contribute to the development and execution of QC Microbiology related supporting studies.
The Quality Control Associate I Microbiology must support all activities to ensure that the instrumentation in WIP labs is prepared for each corresponding unit operation to be performed in manufacturing.
The Quality Control Associate I Microbiology should have a background in microbiological analytical methodologies. The Associate must correctly work with cGMP regulated computerized systems which are necessary for the testing workflow as these systems will support the vision of establishing a paper-less lab and ensure the relevant data integrity. The Quality Control Associate I Microbiology supports the Microbiology Team with establishing analytical procedures and protocols related to microbiological analysis.
The Quality organization at the Solothurn site is envisioned to be supported by team members with diverse backgrounds that are capable of cross functional work to support the high throughput design of the facility. Quality staff is focused on incorporating a new operations strategy into the quality management systems, lab systems and business systems. The operational strategy strongly relies on the incorporation of online real-time monitoring, automation of routine testing wherever possible and integrated information technology systems to bring transparency to routine business operations.
What You'll Do
- Support the QC Microbiology team with day-to-day analytical operations including test execution and review activities of routine EM and UM samples, as well as MFG support samples (e.g. Cleaning samples) and in-process and drug-substance samples.
- Support administrative activities including archival of data, protocol/report and procedure drafting, analytical instrument maintenance activities, deviation management.
Who You Are
The ideal candidate should have a microbiological analytical background, familiarity with cGMP-regulated computerized systems, and the ability to work towards establishing a paperless lab. The role supports the Microbiology Team in protocol development and aligns with the site's focus on new operational strategies, real-time monitoring, and automation.
- Experience within Biological Quality Control, Microbiology and analytical function. Experience in pharmaceutical or biotech manufacturing environment is a plus.
- Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.
- Analytical skills in Microbiology.
- Must have a working understanding of modern analytical microbiological modalities to facilitate the execution of analytical quality strategies.
- Demonstrated problem solving skills.
- Demonstrated ability to work autonomously and cross-functionally.
- Strong presentation and organizational skills.
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.).
- Must have proficiencies with the Quality systems and business processes associated with Microbiology testing.
- English (minimum level B1).
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
-
Quality Control Associate I Microbiology
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About This Role** The main responsibilities for the Quality Control Associate I Microbiology includes execution of all the Microbiology related testing activities at Biogen’s large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include microbiological identification, bacterial...
-
Quality Control Associate Ii Microbiology
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About This Role** The main responsibilities for the Quality Control Associate II Microbiology includes execution of all the Microbiology related testing activities at Biogen’s large scale manufacturing facility in Solothurn, Switzerland. Microbiology related analysis at the site will include microbiological identification, bacterial...
-
Senior Associate III, QA Downstream
Gefunden in: Talent CH C2 - vor 1 Woche
Luterbach, Schweiz Biogen VollzeitAbout This Role The Senior Associate III, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland. It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...
-
Senior Associate II, QA Downstream
Gefunden in: Talent CH C2 - Vor 4 Tagen
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...
-
Senior Associate II, QA Downstream
Gefunden in: Talent CH C2 - Vor 2 Tagen
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...
-
Senior Associate II, QA Downstream
Gefunden in: Talent CH C2 - Vor 2 Tagen
Luterbach, Schweiz Biogen VollzeitAbout This Role The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland. It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in...
-
Senior Associate II, QA Downstream
Gefunden in: Talent CH C2 - vor 19 Stunden
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role The Senior Associate II QA is being part of the Quality Compliance and Technical services team. This role is mainly responsible on Facility, Utilities and Equipment (FUE) Qualification and Validation at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/she is also responsible for the...
-
Manufacturing Upstream Associate Iii
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description**: **About This Role** As a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance...
-
Manufacturing Associate II
Gefunden in: beBee S CH - vor 3 Wochen
Luterbach, Schweiz Biogen International GmbH VollzeitAbout This Role As a Senior Manufacturing Associate II, your primary role involves Perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The...
-
Manufacturing Associate II
Gefunden in: beBee S CH - vor 3 Wochen
Luterbach, Schweiz Biogen International GmbH VollzeitAbout This Role As a Senior Manufacturing Associate II, your primary role involves Perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The...
-
Manufacturing associate V
Gefunden in: Talent CH C2 - vor 1 Woche
Luterbach, Schweiz Biogen VollzeitAbout This Role As a Manufacturing associate V you'll perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is...
-
Manufacturing Upstream Associate III
Gefunden in: Talent CH C2 - vor 1 Woche
Luterbach, Schweiz Biogen VollzeitJob Description As a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards....
-
Weigh & Dispense Associate Iii
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description**: **About This Role** Join our innovative team as a Weigh & Dispense Associate III, playing a crucial role in daily operations in a cGMP environment. You will be responsible for executing Weigh & Dispense manufacturing operations, managing material flow, and ensuring compliance to cGMP standards. As a detail-oriented professional with a...
-
Manufacturing Associate IV
Gefunden in: beBee S CH - vor 4 Wochen
Luterbach, Schweiz Biogen International GmbH VollzeitAbout This Role As a Manufacturing Associate IV, you'll perform processing steps and manufacturing support activities in our facilities in Luterbach (Solothurn). You will be the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. Your responsibilities include performing and...
-
Manufacturing Associate IV
Gefunden in: Talent CH C2 - vor 1 Woche
Luterbach, Schweiz Biogen VollzeitAbout This Role As a Manufacturing Associate IV, you'll perform processing steps and manufacturing support activities in our facilities in Luterbach (Solothurn). You will be the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. Your responsibilities include performing and...
-
Manufacturing Upstream Associate Iv
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description**: **About This Role** As a Manufacturing Upstream Associate IV, you'll perform processing steps and upstream manufacturing support activities in our facilities in Luterbach (Solothurn). You will be the _backbone_ of our operations - each person playing a critical role in delivering our therapies to the patients who need them. Your...
-
Manufacturing Supervisor
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description**: **About This Role** In this role, you will lead and oversee a team of Manufacturing Associates, coordinate shift tasks, and ensure a commitment to cGMP compliance and safety procedures. You will play a pivotal role in maintaining updated manufacturing documentation and serve as a system expert, leading technical issue resolution and...
-
DSP Manufacturing Sciences Engineer III
Gefunden in: beBee S CH - vor 3 Wochen
Luterbach, Schweiz Biogen International GmbH VollzeitAbout This Role Join our team as a critical technical expert for Downstream process transfer and process sciences at our Solothurn Drug Substance manufacturing facility. This position provides key technical subject matter expertise to Downstream process transfer & process sciences activities to support technology transfer & operations at the Solothurn Drug...
-
DSP Manufacturing Sciences Engineer III
Gefunden in: beBee jobs CH - vor 1 Woche
Luterbach, Solothurn, Schweiz Biogen International GmbH VollzeitAbout This Role Join our team as a critical technical expert for Downstream process transfer and process sciences at our Solothurn Drug Substance manufacturing facility. This position provides key technical subject matter expertise to Downstream process transfer & process sciences activities to support technology transfer & operations at the Solothurn Drug...
-
Sr. Engineer II, Automation Core Systems
Gefunden in: beBee S CH - vor 2 Wochen
Luterbach, Schweiz Biogen International GmbH VollzeitAbout this role As Sr. Engineer II, Automation Core Systems, you will be responsible for providing engineering and technical leadership in support of Data Systems at the Solothurn site. Responsibilities include collaboration and building partnerships with site stakeholders and customers to ensure service levels and strategic direction align to the...
