Manufacturing associate V
vor 3 Wochen
About 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 detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.
What You’ll Do
Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation Perform troubleshooting/investigation of equipment and process issues Revises documents as instructed, Capable of equipment and/or process changes Actively participates in training activities, managing their individual training plan. Trains other associates as required. Executes validation protocols Capable of leading shift when supervisor is absent, and actively leads or participates in shift exchanges. Coordinates activities and daily schedules with cross-functional areas And other job duties that may be assigned from time to time
Job Description
Who You Are
You are someone developing a deep passion for doing work that furthers a mission to save lives. You have a high degree of demonstrated learning agility, are energetic, and love a fast-paced work environment where everything you do is incredibly impactful. With many years of related industry experience and exposure to automated systems like Delta V or Syncade, you bring a wealth of knowledge to ensure the highest compliance standards are met.
Required Skills
Bachelor degree in not related field and typically 10+ years Pharma/Biotech years experience Strong understanding of Delta V or Syncade or similar automated systems (potentially able to solve level 1 automation issues) Experience in highly regulated industry Understanding of full Biotech process Languages: English B2 level, German and/or French an asset
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 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. to learn more about our DE&I efforts
-
Manufacturing Associate V
Vor 3 Tagen
Luterbach, Schweiz Biogen Vollzeit**Company Description** About 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...
-
Manufacturing Associate Iii
Vor 3 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 Upstream Associate III
vor 3 Wochen
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....
-
Manufacturing Coordinator V
Vor 3 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...
-
Manufacturing Associate IV
vor 1 Woche
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This RoleAs 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...
-
Manufacturing Associate IV
Vor 5 Tagen
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...
-
Senior Associate II, QA Downstream
vor 2 Wochen
Luterbach, Schweiz Biogen VollzeitAbout 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 Quality...
-
Senior Associate II, QA Downstream
vor 2 Wochen
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...
-
Sr Engineer II, Automation Systems
vor 23 Stunden
Luterbach, Schweiz Biogen VollzeitJob DescriptionAbout This Role As our Senior Engineer II, Automation, you will maintain and troubleshoot all process control system hardware and software, including Programmable Logic Control (PLC), Distributed Control System (DCS), and Manufacturing Execution System (MES) strategies. This support will be for a platform recipe-driven, fully integrated, and...
-
Sr Engineer II, Automation Systems
vor 5 Stunden
Luterbach, Schweiz Biogen VollzeitAbout This Role As our Senior Engineer II, Automation, you will maintain and troubleshoot all process control system hardware and software, including Programmable Logic Control (PLC), Distributed Control System (DCS), and Manufacturing Execution System (MES) strategies. This support will be for a platform recipe-driven, fully integrated, and validated...
-
QA Technical Authority, Quality Technical Services
vor 4 Wochen
Luterbach, Schweiz Biogen Vollzeit**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...
