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Senior CSV Engineer 100% M/F

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Bewertung abgegeben
18.01.2023 100% Festanstellung
Emergent BioSolutions Berna GmbH

Emergent BioSolutions is dedicated to a simple mission: protecting and improving lives. As a global specialty pharmaceutical company, Emergent provides healthcare providers and governments with specialized products to address medical needs and emerging health threats.

 At Emergent BioSolutions Berna GmbH, the manufacturing site in Thörishaus near Bern, travel vaccines are produced and exported all over the world. Around 130 employees work in the areas of manufacturing, quality assurance and control, supply chain and regulatory affairs. Emergent Berna is therefore a significant pillar in the global Emergent network.

 To complement and strengthen our team in CQV we are looking for a

Senior CSV Engineer 100% M/F

Your tasks include

  • Plans, coordinates, and executes assigned projects by effectively using Project Management methodologies
  • Reviews and approve CSV-related system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols)
  • Perform hands-on field work for equipment, aseptic processing, steam sterilization, cleaning validation, and process validation and their associated control systems
  • Uses proven monitoring and problem-solving techniques such as SPC and DMAIC
  • Provides customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader within the Commissioning and Qualification department
  • Act as a coach and mentor to other members of EFV and project teams to drive continuous improvement, knowledge transfer, and professional growth of self as well as colleagues
  • Has wide-ranging experience, using professional concepts and company objectives to resolve complex issues in more efficient ways than lower levels.
  • Drives the complete execution of assigned projects in a manner that drives high engagement from project team members.

What you bring to the table

  • A minimum of 5 years of experience in a biopharmaceutical or related environment in the area of system qualification or validation
  • BS/MSc in IT or equivalent with a strong track record in Biotech-Industry,
  • Project/Program Management
  • Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, the candidate is expected to be able to guide the site to top-quartile operational safety, efficiency, and compliance for these technologies
  • Ability to think and act both strategically and tactically
  • Highly effective verbal and written communicator at all levels of the organization
  • Demonstrated ability to effectively prioritize and coordinate activities
  • Proficiency in Microsoft Office applications and validation-specific software programs
  • Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity
  • Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.
  • Subject Matter Expertise in Computer Systems Validation
  • Languages: German and English, oral and written

Do you want to join our mission in a motivated team? Please submit your application under the following link: https://careers.emergentbiosolutions.com/job/Bern-Senior-Computer-System-Validation-Engineer/982375500/

Adresse

Emergent BioSolutions Berna GmbH
Herr Daniel Mauron
Director Human Resources
+41 31 8885225
Write an email

Website https://www.emergentbiosolutions.com/