stillingsbetegnelse:
Supervisor, Equipment Validation – Large Scale Manufacturing

jobbeskrivelse:
On behalf of Biogen Idec’s Site Hillerød, we are looking for a dynamic and strong team player – with proven experience within Validation and Project & People Management. THE CHALLENGE The Supervisor, Equipment Validation LSM reports to the Sr. Manager Validation GE&F – Principle Accountabilities: •Coordinates Equipment/Cleaning Validation Protocols (development, training, management, tracking) – includes time spent on production floor •Provides input & validation guidance to tech Transfer and project/area efforts, supports global alignment of best practices across sites, attends related meetings for project/area/cross-site initiatives •Writes Validation-related reports and project plans, maintain resources planning and allocation •Assess and approves Trackwise-generated workflows (deviations, core change controls) and automation protocols, attends related meetings •Provides guidance to Jr. Validation Associates as well as contractual staff •Maintains training, develops goals, and tracks progress and performance of team members •Initiates/Reviews/Supports updates to SOP’s and forms THE IDEAL CANDIDATE •Solid GMP knowledge and QA/Manufacturing/Engineering experience, from a similar position – preferably gained from working within one of the following industry segments: Biotech, pharmaceutical or related •8 to 10 years of experience – including 4 years of experience when it comes to Team Lead and Supervisory skills of small to medium sized team •Relevant educational background like e.g. BA or B.Sc. in physical or biological sciences •Experience in Cleaning (CIP), Sterilization (SIP) and Equipment Validation Philosophy •Excellent written and oral communication skills in English •Experience from working cross-functionally as well as working with people from different cultures •Practical knowledge of FDA and EMEA regulations •Experience with regulatory audits •Excellent IT skills PERSONAL SKILLS/KEY WORDS •Have strong drive and high motivation - Possess the ability to work effectively in a collaborative team environment •Ability to work off-hours – should the need arise •Extrovert and outgoing – Excellent communication skills •Team player/Adaptable/Constructive/High energy level •Strong language skills – in English APPLICATION Please forward your application including CV, and other relevant documents to: steen (at) storbjergsearch.dk – REF Supervisor Equipment Validation. For further information please contact: STORBJERG Search & Selection/Steen Storbjerg Nielsen +45 2999 9689. Storbjerg Search & Selection v/Steen Storbjerg Nielsen -------------------------------------------------------------------------------- THE COMPANY About Biogen Idec Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, autoimmune diseases and hemophilia. As a company, Biogen Idec recognizes that cutting-edge science and medicines can change the course of devastating diseases. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Our development pipeline is one of the strongest in the industry and patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. In the coming years, we’re working hard to bring new therapies to market for patients with serious neurodegenerative, non-malignant hematologic and autoimmune diseases. With approximately 7,000 people worldwide, Biogen Idec is truly a global organization. Biogen Idec’s European production site in Hillerød 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. Biogen Idec in Hillerød is an exci

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark