Automation Quality Engineer
External Posting TitleAutomation Quality EngineerJob DescriptionMAIN PURPOSE:
The QA Automation Engineer is responsible for supporting the setup and structure of the automation and MES systems (Delta V and Syncade)to enable the start-up, commissioning and validation of the new Large Scale Manufacturing facility to be located at the Solothurn, Switzerland capus.
This will include providing the Biogen Quality Management System input on review/approval of automation validation and engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where Quality Assurance needs to approve before implementation and upon completion.
Furthermore, this role may be an active member of automation groups/project teams in which Quality input is needed. These projects could be cross-functional in nature and may involve participation across sites as well.
The QA Automation Engineer will work in/on systems that control key functional, tactical and operational aspects within the Quality Assurance organization at the Biogen Solothurn Facility.
The QA Automation Engineer may participate as a Team member in activities related to interviewing, hiring and training of employees, as well as compliance with training policies.
1. Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) specifically related to automation and MES systems (Delta V, Syncade, etc.)
2. Provide support to multiple areas within the facility and may participate on projects across sites; requiring a good working knowledge of regulatory and Biogen Quality and Process systems as well as working knowledge of key automation/MES systems
3. Work alongside more senior members of the Quality Engineering Team to revise/develop and implement complex Quality systems that can be global in scope
4. Ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)
5. Performs Quality review and approval of change control documents and activities associated with change controlLocationSolothurn, SwitzerlandJob CategoryQualityRequisition Number28548BRQualificationsFor the first year may need to travel up to 50% in support of design, implementation and Factory Acceptance Testing related to the facility start-up activities.
- 5 to 7 years of experience in pharmaceutical or biotech manufacturing environment.
- Maintain knowledge of relevant FDA/EMA regulations and compliance.
- Previous experience within Quality Assurance or related function is preferred.
- Good communication skills in English, verbally and written. Technically orinented role including experience of the validation of laboratory, production equipment automation systems and knowledge of production methodology involved in biopharmaceutical production.
- Self driven, demonstrated ownership and responsibility for work assignments. - - Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization.
- Ability to work with colleagues across the organization.EducationBachelor’s Degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer ScienceAbout BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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