stillingsbetegnelse: Validation scientist

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! The Department CMC Biologics is heading towards commercial manufacturing and the validation team will play a vital part by supporting the organization being in compliance with the consequential higher demands. The daily challenges will be solved in cooperation with the QA department as well as other departments in the company. The Validation team is a small team consisting of 4 scientists and a Validation manager, which will be the direct report for this role. The team is a part of the Engineering department. Tasks and Responsibilities As a Scientist you will be responsible for and have influence in a broad variety of areas. You will be responsible for: • Preparation and maintenance of the overall CMC system for qualification, Cleaning and Validation Master Plans. o You will prepare, update, optimize and standardize procedures related to qualifications and Cleaning Validation. • Acting as quality responsible on equipment projects o Determine qualification effort. o Coordinate and follow-up on quality activities. o Ensure internal procedures are followed and implemented. • Performing qualification and cleaning activities related to equipment and systems o Preparation of VPL/VPR, IQ/OQ/PQ protocols and reporting for qualification and Cleaning Validation. o Performing qualification tests including trouble shooting and handling deviations. • Maintaining overview of qualification status for all equipment used for cGMP activities including plans for periodic review and requalification activities. • Preparing EOS APR, water system trend and overview reports, deviation, change requests and CAPAs as appropriate. • Supporting other departments regarding training, technical advice and establishment of user requirement specifications. • Sharing best practices on qualification/¬validation with our validation team in Seattle. • Participating in customer and agency audits. • Ad Hoc tasks as appropriate. Your Profile The ideal candidate will possess: • A bachelor or master degree within the fields of engineering, pharmacy or equal. • Experience in/knowledge of regulatory requirements for the pharmaceutical industry. • Experience with customer and authority audits. • Have a structured and disciplined approach to planning and problem solving CMC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English. CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience the way the various departments throughout a Contract Manufacturing Organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. CMC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. CMC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. For further information regarding the position, please do not hesitate to contact Validation Manager Thomas Arnt Jensen, telephone +45 2294 2932 We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than 14th of December 2014. About CMC Biologics A/S CMC Biologics (CMC) is a global Contract Manufacturing Organization (CMO) with three biomanufacturing facilities in Europe and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formul

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark