Quality Engineering Manager (for Automation)
External Posting TitleQuality Engineering Manager (for Automation)Job DescriptionMAIN PURPOSE:
The Manager, Quality Automation 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 campus.
The Solothurn campus is intended to operate with a fully integrated electronic batch record.
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.
This role will likely be involved in the creation and implementation of systems which govern the validation and change control of the automation and MES systems being implemented at the Solothurn campus.
The projects in which this role will be involved will be cross-functional in nature and may involve participation across sites as well. Manager, Quality Automation will work in/on systems that control key functional, tactical and operational aspects within the Quality Assurance organization at the Biogen Solothurn Facility.
Manager, Quality Automation will participate as a Team member/leader in activities related to interviewing, hiring and training of employees, as well as compliance with training policies. For 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. Will assist in the initial hiring of the Quality Engineering Automation Team for the Solothurn campus.
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 senior members of the Quality Engineering Team, as well as other stakeholder groups, to revise/develop and implement complex Quality systems that can be global in scope
4. Ensure adherence to internal procedures for facility/equipment and automation 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 Number28548BRQualifications- Maintain knowledge of relevant FDA/EMA regulations and compliance.
- Maintain knowledge of GAMP and applicable automation regulatory knowledge
- Approximately 10 years of experience in pharmaceutical or biotech manufacturing environment.
- Previous experience within Quality Assurance, Validation, Automation/MES or related function strongly preferred.
- Good communication skills in English, verbally and written.
- Technically oriented role including experience of the validation of laboratory, production equipment automation and manufacturing execution systems (MES) 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. Ability to lead, support and motivate a Team including the prioritization
*LI-POT4EducationBachelor’s Degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer ScienceAbout BiogenThrough cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
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. With a strong affiliate presence and a network of distribution partners, Biogen has established a global footprint that allows us to capture the greatest value for the products we develop.
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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