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353554 MSD AH Danube Biotech GmbH

Validation and Qualification Engineer(m/w/x)

Krems an der Donau
from 50,000 / year
Full-timeWith Home OfficeExperienced
Apply now

Developing sterilization processes and qualifying production equipment for biopharmaceutical vaccines and immunotherapies. Experience in GMP production and equipment/process validation required. Collaboration across diverse teams.

Requirements

  • Bachelor, Master or Engineering degree in Biotechnology, Process Engineering, (bio)chemistry, (micro)biology, or similar
  • Ability to track qualification/requalification activities
  • Adequate communication at all organizational levels
  • Experience in GMP production company
  • Experience in equipment qualification and process validation
  • Strong knowledge and hands-on experience of (bio) process technology
  • Strong knowledge and hands-on experience of microbiology
  • Strong knowledge and hands-on experience of aseptic processing
  • Strong knowledge and hands-on experience of equipment design
  • Practical experience in risk management tools application
  • Excellent communication and organizational capacity
  • Experience in change management
  • Ability to manage deviations and CAPAs
  • Experience in continuous improvement tools and methodologies
  • Very good knowledge of MS-Office applications
  • Very good knowledge of German (verbal and written)
  • Very good knowledge of English (verbal and written)

Tasks

  • Lead qualification and validation activities
  • Prepare qualification plans, protocols, and reports
  • Develop procedures based on internal and external standards
  • Plan and execute equipment and system qualifications with stakeholders
  • Plan and execute cleaning and process validation with stakeholders
  • Develop sterilization process cycles
  • Qualify sterilization processes (thermal, chemical, physical)
  • Re-qualify sterilization processes (thermal, chemical, physical)
  • Participate in equipment, system, and process risk analysis
  • Moderate equipment, system, and process risk analysis
  • Perform Computerized Systems Validation (CSV) with IT and Process Automation
  • Support improvement projects for qualification and validation
  • Solve problems in qualification and validation activities
  • Support change, deviation, and CAPA management
  • Train staff in equipment qualification, risk assessments, and validation
  • Ensure compliance with company safety guidelines
  • Identify and address unsafe situations

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • German – Business Fluent
  • English – Business Fluent

Tools & Technologies

  • Risk Management Tools
  • Continuous Improvement Tools
  • MS-Office

Benefits

Additional Allowances

  • Outstanding social benefits
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