Arbejde Validation Engineer unspecified BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud
reference: 4904715
documentId: 4904715
connectionPointId: 7
lastModificationDate: 1542105966766
stillingsbetegnelse: Validation Engineer
jobbeskrivelse:
Biogen in Hillerød is looking for a new colleague for the operations team in the Validation Engineering department.
Job Category
Engineering
Requisition Number
35113BR
Job Description
The Validation Engineering department at Biogen site Hillerod is responsible for the validation of production equipment, cleaning, sterilization, chambers, glasswashers and autoclaves as well as running/executing projects. The department consist of 8 FTE’s and a varying number of contractors all based in Hillerod, sharing the responsibilities.
We have an open position in the operations team, yet based on your experience and profile, you will have opportunities to impact your own area of responsibility.
Primary responsibilities:
• Preparing, coordination, executing, driving and reporting validation activities to closure for equipment in our Drug Substance Production
• On-the-floor support to validation execution activities, and support to manufacturing when needed.
• Participate in miscellaneous projects, both with execution and documentation.
• Investigating validation deviations to determine the impact on the product quality, system operations, and other compliance systems, and supporting general investigations when needed.
• Preparing and performing review of validation and, engineering reports as well as review of URS, FAT/SAT documents, commissioning plans and reports, and operational/validation procedures to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.
• Providing SME guidance and assessments on validation impacts and requirements when equipment and systems are subject to modifications or changes.
• Preparing and reviewing technical reports, risk assessments, annual regulatory validation summary plans and reports related to equipment and products.
• Participate actively in audits and regulatory inspections, prepare audit responses and tracking sheets, compile and write status reports
• Support to manufacturing improvements as needed
Qualifications
The successful candidate will have 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 profound 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.
The Validation Engineer, must be able to navigate in a multi-cultural environment and must have excellent communication skills. You are flexible as manufacturing runs 24/7/365. Work outside normal working hours or during weekends must be expected.
You have experience within several of the following areas:
• Experience in pharmaceutical or biotech manufacturing environment
• Knowledge and experience with cleaning validation (CIP) preferably sterilization validation (SIP), utilities validation (water/steam/gasses)
• Basic engineering knowledge, able to trouble-shoot engineering issues
• Commissioning and automation validation knowledge
• In-depth knowledge of biopharmaceutical equipment and process technologies and clean utilities
• Knowledge of the interaction between equipment and automation
• Competency in MS Word, Excel, Power Point and Project
• Excellent oral and written communication skills in English
Education
The ideal candidate carries a Bachelor / Master Science Degree in an engineering or scientific discipline combined with validation experience in an EMA/FDA regulated environment.
Biogen offer diverse career development opportunities, great working environment and a competitive compensation package.
Application
For further information please feel free to contact Sr Supervisor Connie Jakobsen phone +45 77 41 62 09 or Sr. Manager Jacob Øgaard phone +45 25 66 30 76
Please uopload your application and CV as soon as possible as we will screen apllications on a continuous basis.
Employment Category
Full-Time Regular
Experience Level
Entry Level
numberOfPosts: 1
jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421
abstractJV_contact_0: Please apply using one of the specified channels
positionTypeCode: directhire
contractTypeCodes_0: fulltime
Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS
source: DK-STAR
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