stillingsbetegnelse:
Validation Engineer – Device Assembly, Labelling & Packaging - Biogen

jobbeskrivelse:
Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is the world’s oldest independent biotechnology company. 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 secondary progressive MS, Alzheimer’s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others. With approximately 7,500 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. • Are you a recent graduate within Technical or Pharmaceutical Engineering? • Do you have the right drive and thirst for knowledge? • Would you like to learn all about general validation principles, deviation resolutions, and Device Assembly, Labelling & Packaging processes? If the answer is yes to the above questions this 12 month contract, may be the right career move for you. Job Description: We are currently very busy and therefore we need an additional colleague for 12 months. The team is responsible for validation support to Assembly, Label & Pack. Your main responsibility will to be part of designing, performing and summarise validations for new and upgraded biopharmaceutical assembly, label and packaging equipment. You will also take part in investigating deviations during validation to determine the impact of the product quality, system operations, and other compliance systems and participates actively in various projects and workshops. Responsibilities also include: • Partnering with Engineering, Manufacturing and Quality Engineering to ensure the validated status of the equipment • Provide technical information and support to other disciplines to assure that company products and processes conform to regulatory and industry requirements • Provide guidance on validation requirements when equipment and systems undergo modifications (change control). Prepares and reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology. Your profile: The ideal candidate will hold a degree within Technical Engineering (e.g. Mechanical, Production and Automation) or similar and is ready to kick start the career. You have GMP knowledge, and it will be an advantage, but not a requirement, if you have knowledge of and experience with validation and qualification of equipment. You are technically sound and have a good understanding of production equipment and procedures. You are proficiently using IT tools and a high level of English. As a person you thrive in a multicultural environment where things move fast. You are proactive, responsible, organised and able to take ownership of tasks. Furthermore, you are good at interacting with others and a good team player who thrives on setting a good example. You are flexible in relation to duties and working hours. You must be keen on learning new things, and the first period will of course include thorough training. You must be eager to learn by doing as you will be trained by getting your own tasks – of course with support. Application: Do you have the skills required and the motivation for this position, please apply for this job through the link. Applications must be

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark