QA Technical Authority, Quality Technical Services
Vor 2 Tagen
**Job Description** About This Role**
This position is providing Quality Assurance input and drives activities and projects in compliance with cGMP, regulatory requirements, Quality Management System and change control system. The main responsibility is accomplished by relevant knowledge in Bulk Drug Substance manufacturing processes and the QMS to continually improve all aspects of the Quality Management System and processes. This position will contribute to ensure quality oversight and support for New Product Introduction activities (NPI), equipment and system qualifications and site deviations. This role is expected to be cross-functional between the Luterbach QA, site organization and corporate quality functions, and will also work closely with other business groups as, but not limited to, quality systems, quality control, manufacturing science, and supply chain.
You will have close collaboration with global functions (e.g. BPOs, QSOs and other Biogen sites (such as RTP site) and business groups. As such, the position is expected to have high level knowledge in manufacturing operations, equipment use and business processes within a cGMP Biotech environment as well experiences on manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation, Enterprise Resource Planning and Change Control
**What You'll Do**
- Support deviations/GMP investigations and other quality processes to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs). Support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
- Contribute to the batch disposition process by ensuring that all required documents are accurately and properly completed and ready for batch disposition, including all batch related deviations.
- Support inspection readiness, regulatory requests and Partners communication and requests coordination.
- Support the review metrics for identification of negative trends and drive QMS and qualification/validation improvements.
- Act as local QMS representative (eg. CAPA, Change Control, Deviation etc.) and support the review metrics for identification of negative trends.
- Provide quality oversight of qualification activities (incl. protocols and reports) and change control process to support equipment and system qualification activities including appropriate life cycle management. Revise and approve Standard Operating Procedures, work Instructions and documentation as needed.
- Provide transversal support to QA operational teams upstream and downstream as needed during NPI or projects and/or peak periods.
**Who You Are**
You bring over 10 years of quality assurance and/or operational experience in pharmaceutical or biotech manufacturing, showcasing expertise in electronic operations, team management, and strong knowledge of GxP regulations. You have strong leadership skills, and a background in process design and improvement are essential.
**Qualifications**
- Masters in Science I Engineering in Life Science orTechnical discipline.
- Approximately 10 years or more of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
- Experience in team management is an asset.
- Good experience of process design and improvement. Strong working experience with GxP regulations.
- Electronic Batch Record and elogbook management will be an asset.
- Must have a good understanding with the Quality systems and business processes associated with automation and integration o f testing and production systems.
- Demonstrated and proved ability to work autonomously
- Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Experience in drug substance (or API) and drug product is mandatory.
- Good experience in participating in pharmaceutical technology transfer team.
- Good experience in the qualification of facilities, utilities, equipment and processes.
- Experience in preparing and coordinating regulatory inspections.
- This position may require international travel.
- Dual Language preferred with a preference for German and English level B1.
**Additional Information**
**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 refle
-
QA Sr. Associate Ii
vor 23 Stunden
Luterbach, Schweiz Biogen Vollzeit**Job Description** A** **About 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...
-
Luterbach, Schweiz Biogen VollzeitAbout This Role The Associate II within the Integrated Downstream Quality Operations team is part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn site is...
-
Luterbach, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Associate II, Integrated Downstream Quality Operations, LuterbachClient:BiogenLocation:Job Category:OtherJob Reference:9934de2eb6f1Job Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:About This RoleThe Associate II within the Integrated Downstream Quality Operations team is part of the Quality...
-
Manufacturing Coordinator V
Vor 5 Tagen
Luterbach, Schweiz Biogen VollzeitThe coordinator V is responsible for supporting / enabling manufacturing activities in regard to Compliance, Documentation, Recipe driven operations, Changeover, Tech transfer, and or Training for day-to-day activity. In addition, the Coordinator V is in charge to represent Manufacturing by participating in intra, cross site alignments and cross functional...
-
Sr. Manager, Upstream Process Technology, MSAT
Vor 2 Tagen
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role As Sr. Manager, Upstream Process Technology you will join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. You will lead cross-functional teams to facilitate new product introduction, process transfers,...
-
Sr. Manager, Upstream Process Technology
vor 1 Tag
Luterbach, Schweiz Biogen VollzeitAbout This Role As Sr. Manager, Upstream Process Technology you will join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. You will lead cross-functional teams to facilitate new product introduction, process transfers, validation and...
-
Lab Technician – Sample Management
Vor 5 Tagen
Luterbach, Schweiz Eurofins Humangenetik & Pränatal-Medizin VollzeitFull-timeCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the...
-
Lab Technician – Sample Management
Vor 5 Tagen
Luterbach, Schweiz Eurofins GSC Poland Sp. z o. o. VollzeitLab Technician – Sample Management (EM/UM)49_743999930855931Obowiązki In this position, you will be part of the environmental monitoring (EM) and utility monitoring (UM) team. Your main responsibilities will include, but are not limited to:GMP-compliant, independent and on-time performance of routine sample collection and managementCreating and...
-
Mfg Scientist II
vor 1 Tag
Luterbach, Schweiz Biogen VollzeitAbout This Role The Mfg Scientist II will provide key technical leadership for materials and analytics of clinical and commercial manufacturing campaigns at the Solothurn Drug Substance manufacturing facility. You will be part of the Global Manufacturing Sciences group. You will lead raw material investigation, forensics and analytics in the...
-
Maintenance Reliability Lead
vor 1 Tag
Luterbach, Schweiz TN Switzerland VollzeitAs Maintenance Reliability Lead, you will manage the asset reliability program for the site to maintain highly reliable and compliant equipment and systems. You will partner with Global Engineering, Manufacturing Engineering, Operations, Maintenance, and other functions to establish and maintain a world-class reliability program. You will establish...
-
Operator II, Utilities
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit- Ensure 24/7 shift operations and keep up and running all utilities (Black utilities, Clean Utilities, HVAC) through scada monitoring systems (DeltaV and Siemens Desigo - Operate utilities systems according instructions, procedures - Execute shift tasks according shift lead instructions and operational plan - Execute maintenance / revision work (repairs...
-
Maintenance Reliability Lead
vor 1 Tag
Luterbach, Schweiz Biogen VollzeitAbout This Role As Maintenance Reliability Lead you will manage the asset reliability program for the site to maintain highly reliable and compliant equipment and systems. You will partner with Global Engineering, Manufacturing Engineering, Operations, Maintenance and other functions to establish and maintain a world-class reliability program. You...
-
Qc Microbiology/sml
Vor 2 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About Us**: Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. With a high level of automation and advanced processes, our state-of-the-art plant is at the forefront of modern manufacturing. Join our...
-
Mfg Scientist II, Luterbach
vor 1 Tag
Luterbach, Schweiz TN Switzerland VollzeitThe Mfg Scientist II will provide key technical leadership for materials and analytics of clinical and commercial manufacturing campaigns at the Solothurn Drug Substance manufacturing facility. You will be part of the Global Manufacturing Sciences group.You will lead raw material investigation, forensics and analytics in the Manufacturing Sciences Laboratory...
-
Storekeeper/lagermitarbeiter
vor 2 Stunden
Luterbach, Schweiz Bilfinger Vollzeit**Storekeeper/Lagermitarbeiter** Standort: Luterbach **Principal accountabilities** - Manage CMMS inventory system of technical warehouse - purchasing and receiving goods and spare parts - issuing of inventory based on work order demand **Knowledge and skills** - Good working knowledge of CMMS systems and good maintenance practices - Experience in...
-
Engineer III, Automation, Luterbach
Vor 2 Tagen
Luterbach, Schweiz TN Switzerland VollzeitAs our Engineer III, Automation, your main responsibilities include maintaining and troubleshooting all process control system hardware and software Distributed Control System (DCS), Manufacturing Execution System (MES), Programmable Logic Control (PLC) strategy in Business Execution System (BES) team supporting a platform recipe driven, fully integrated,...
-
Engineer III, Automation
Vor 2 Tagen
Luterbach, Schweiz Biogen VollzeitAbout This Role As our Engineer III, Automation, your main responsibilities include maintaining and troubleshooting all process control system hardware and software Distributed Control System (DCS), Manufacturing Execution System (MES), Programmable Logic Control (PLC) strategy in Business Execution System (BES) team supporting a platform recipe...
-
QC Microbiology/SML
vor 1 Tag
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout Us:Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. With a high level of automation and advanced processes, our state-of-the-art plant is at the forefront of modern manufacturing. Join our dynamic...
-
Manufacturing Associate Iii
Vor 5 Tagen
Luterbach, Schweiz Biogen Vollzeit**Job Description** About This Role** As a Senior Manufacturing Associate III, 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...
-
Manufacturing Engineering Internship
Vor 7 Tagen
Luterbach, Schweiz Biogen VollzeitAbout Us:Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. With a high level of automation and advanced processes, our state-of-the-art plant is at the forefront of modern manufacturing. Join our dynamic team to gain...
