stillingsbetegnelse: Validation Engineer – Chambers

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 Validation Engineer will have related Validation/Quality experience and strong knowledge and technical understanding of temperature controlled chambers. 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. 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. About the job: You will report to the Sr. Validation Manager and be part of a skilled team of 10 colleagues and your primary responsibilities as a validation engineer will be planning, driving and executing Qualification and Validation of temperature controlled chambers (e.g. refrigerators, freezers, incubators, cold rooms and warehouses) and autoclaves at site Hillerød. 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 •Prepares, executes, and finalizes protocols (VPP/VFR, IQ, OQ, and PQ) for validating new and modified temperature controlled chambers and autoclaves. •Presenting validation reports and other relevant documentation during regulatory audits be able to act and present as an expert within your area of responsibility •Partners with Engineering, Manufacturing, and Quality in deviation handling and changes to equipment. •Oversee and supervise contractors on an as need basis 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 and facilities organization as well as quality control and quality assurance. 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 professional qualifications: •Solid knowledge of GMP •Practical experience with temperature/humidity mapping equipment (e.g. Kaye) •In-depth knowledge and technical understanding of chambers and autoclave functionality and associated validation activities •In-depth knowledge and technical understanding of temperature mapping theory and praxis •In-depth knowledge and technical understanding of sterilization 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 work morale is high •Strong team player and flexible with regards to working hours as the site operates 24/7,

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

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