stillingsbetegnelse: Experienced Cell Culture Validation Engineer

jobbeskrivelse:
Biogen Idec 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. Our new Senior Validation Engineer will have with experience from related Validation/Quality experience and you have strong SIP and CIP knowledge. You will welcome the challenge to work for a highly recognized company like Biogen Idec with strong focus on results achieved through dedicated work and a strong focus on common values and common targets. Your team and you will support a lot of customers in-house as well as outside and it will be your common responsibility to further develop the team spirit. The job: You will report to the Sr. Manager Validation and be part of a skilled team of 9 colleagues. Your primary responsibility as a senior validation engineer will be to design, perform, and summarize validations for new and upgraded bio-pharmaceutical manufacturing equipment, facilities, and clean utilities related to our Cell Culture area. You will serve as a validation specialist being responsible for planning, coordination, and driving validation activities to closure. You will also act as the primary decision maker during resolution of protocol deviations and validation related issues. Besides your responsibilities will be: Compilation and review of equipment documentation packages Investigates deviations to determine the impact on the product quality, system operations, and other compliance systems Presenting validation reports and other relevant documentation during regulatory audits and be able to act and present as an expert within your area of responsibility Partners with Engineering, Manufacturing, and Quality Engineering in deviation handling and changes to equipment, facilities and utilities Oversee and supervise consultants to support the validation workload Lead/participate in cross-site validation process improvement initiatives The work place: Biogen Idec’s European production site in Hillerød offers a dynamic working environment where more than 550 employees representing more than 18 different nationalities and strive for the best results. In Biogen Idec 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: Solid knowledge of GMP In-depth knowledge and technical understanding of cell culture process equipment and associated validation activities Practical experience with temperature mapping equipment In-depth knowledge and technical understanding of sterilization theory and praxis In-depth knowledge and technical understanding of equipment cleaning validation theory and praxis Strong English skills verbally and in understanding Your personal qualifications: Strong scientific analysis and troubleshooting skills Proactive, outgoing and highly enthusiastic behavior 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 Strong team player and flexible with regards to working hours as the site operates 24/7, (the position is a Monday-Friday, day shift position) Your formal education: Either you are M.Sc. in Pharmacy, Engineering, Chemistry or equivalent with 5-6 years of related Validation/Quality experience or You hold a Bachelor in a Science degree in an engineering or scientific discipline with 8-10 years Validation/Quality experience Your compensation: We offer an attractive salary package, pension and health insurance. Furthermore we offer a healthy and non-smoking workplace. Further information and application: Ar

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

Arbejdsgiver telefonnummer: +45 7741 6000

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark