stillingsbetegnelse: Senior QA Specialist to Quality Engineering

jobbeskrivelse:
Biogen discovers, develops and delivers innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Patients worldwide benefit from its leading multiple sclerosis therapies. The new Quality Engineer must have at least 4 years of relevant industry experience with both executions of projects in a GMP compliant manner and support of a running facility with mammalian cell culture and protein purification processes, either from a QA function or a manufacturing supporting role. You will welcome the challenge to work for a highly recognized company like Biogen with strong focus on results achieved through dedicated work and a strong focus on common values and common targets. The job: You will report to the Sr Manager of Quality Engineering, and be part of a skilled team with 13 QE colleagues. The QE team supports both the Large Scale Manufacturing and the Label & Pack facility and we are looking for a person with experience in execution of large projects including validation of process equipment and facilities. Your primary responsibility as Quality engineer will be to provide quality and compliance leadership to support to already ongoing expansion project of our Large Scale Manufacturing facility; you will interact with numerous departments like validation, manufacturing, engineering, maintenance, metrology, facility and automation. As Quality Engineer you are responsible for the Quality support and assessment for change controls, deviations, equipment validations, cleaning validation, automation changes, equipment alarm assessment, metrology and maintenance work order review etc. Quality is the key word in this job and therefore it is natural for you to have an on-going dialogue with your colleagues regarding how we ensure quality and compliance, improve our operations and avoid errors. The work place: Biogen’s European production site in Hillerødoffers a dynamic working environment where more than 600 employees representing more than 18 different nationalities strive for the best results. In Biogen you will get the opportunity to influence your own future through creativity and innovation. The Hillerød site has a pivotal role in the supply of medicine to patients across the globe. The site hosts a large scale facility for manufacturing biologics, an assembly, label and packaging facility, an engineering & facilities organization as well as quality control and quality assurance. Your professional qualifications: •At least 4 years of experience from Pharmaceutical / biotechnology industry •Solid knowledge of GMP •Strong English skills verbally and in understanding •In-depth knowledge and technical understanding of biotech process equipment and validation of those is preferable •Experience with support of a biotech facility Your personal Profile: •Strong scientific analysis and troubleshooting skills and have attention to details •Able to manage several tasks simultaneously as well as enjoy being part of a busy high pace and dynamic environment where the working morale is high •You thrive in an international, multi-cultural environment, where changes are not rare •You are proactive, outgoing, service minded and have a highly enthusiastic behavior •You create good working relationships with your colleague; you are a strong team player •You have good communication skills •You bring a sense of humor and energy to work every day Your formal education: •BA or Master of Science in Engineering, Pharmacy, Chemistry, Biotechnology or equivalent Your compensation: We offer you an attractive salary package, pension and health insurance. In addition we offer you a healthy and non-smoking workplace with focus on the well-being of everyone working here. Information and application: For further information you are welcome to contact Beirholm Search, Hanne Beirholm tel. 39403927 who is responsible for finding the right candidate for this position. This

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark