stillingsbetegnelse: Experienced Validation Engineer

jobbeskrivelse:
Job Description As an Engineer III, Validation you will be responsible for preparing, executing, and reporting equipment validation activities for new and modified bio-pharmaceutical manufacturing equipment primarily in our Media Prep, Cell Culture and Harvest areas. In periods support to validation activities related to Utilities and stand-alone/support equipment will become relevant. You are responsible for planning, coordination, and driving validation activities to closure. In addition you will provide validation protocol training and on-the-floor support during validation execution activities. Furthermore you will be responsible for: • Prepare validation project plans and reports. • Investigating validation deviations and non-conformance deviations to determine the impact on the product quality, system operations, and other compliance systems. • Performing final review of validation and engineering reports as well as review of URS, FAT/SAT documents, and commissioning plans and procedures. • Providing SME guidance and assessments on validation impacts and requirements when equipment and systems are subject to modifications or changes. • Reviewing technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology. • Prepare annual regulatory validation summary plans and reports related to equipment and products. • Participate actively in regulatory audits and prepare audit responses. • Participate in cross site meetings as well as drive cross site initiatives. • Participate in miscellaneous project related administrative tasks e.g. update validation metrics and tracking sheets, compile and write status reports and update procedures • Able to manage several tasks simultaneously as well as enjoy being part of a busy and dynamic environment where the working morale is high JIX1 *LI-DEN2 Location Denmark-Hillerod Job Category Quality Requisition Number 25292BR Qualifications Your profile The successful candidate will demonstrate an advanced knowledge of the business as well as a proactive, outgoing and highly enthusiastic behavior to the job. You are used to leading your own projects, have a great sense of responsibility and are used to taking ownership as well as leadership. A high level of persistency, drive and service combined with a strong commitment and attention to detail is crucial to succeed in the job. You must be able to navigate in a multi-cultural environment and must have both good communication and cross cultural skills. The ideal candidate is highly self-motivated, flexible and is able to direct others at both tactical and strategic levels, in a busy high-volume environment. Furthermore it is expected that you have: • 5-8 years’ experience in pharmaceutical or biotech manufacturing environment. • Strong knowledge and experience with cleaning validation (CIP), sterilization validation (SIP), utilities validation (water/steam/gasses). • In-depth knowledge of biopharmaceutical equipment and process technologies and clean utilities as they relate to validation. • Strong cGMP knowledge • Competency in MS Word, MS Excel, MS Power Point and MS Project. • Excellent oral and written communication skills in English. Education The ideal candidate carries minimum a Bachelor of Science Degree in an engineering or scientific discipline combined with 5+ year’s validation experience in an EMEA/FDA regulated environment. Application For further information please feel free to contact Sr. Manager Palle Gregersen +45 2566 3041 or Recruiting Partner Eva Op De Beeck. +45 7221 0860 Apply online. Your application and CV must be in English. Applications will be reviewed on an ongoing basis. About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic cond

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark