Senior Validation Specialist

3 weken geleden


Geleen, Limburg, Nederland Lonza Voltijd

At Lonza, we are seeking a talented Senior Validation Specialist to join our team. This role is a great opportunity to work in a dynamic environment where you will be responsible for reviewing and approving documentation, overseeing qualification/validation/verification of QC analytical methods, and validating manufacturing, cleaning, disinfection, and shipping processes.


Key Responsibilities:



  • Oversee method and process verification/qualification/validation deliverables
  • Review and approve process FMEA for the assessment of process parameters
  • Ensure the correct application of validation requirements
  • Understand cGMPs, GAMP, ICH Q7A, and validation practices (IQ/OQ/PQ) and their application in practice
  • Contribute to the long-term strategic development of the validation program and related plans and projects related to method, process, cleaning, and disinfection, and shipping validation
  • Own QA-related quality system deliverables (CAPA, Change Control) and use project management skills to coordinate related activities, drive timely results for successful milestone completion, and limit compliance risks

Requirements:



  • B.Sc/M.Sc. in Biology/Biomedical science, Life Science, or other job-related discipline
  • Dutch working permit
  • English language skills, fluent
  • GMP experience
  • Relevant experience, at least 3 years in Quality control/Validation/Manufacturing Science and Technology
  • Flexibility in getting the job done with appropriate quality level
  • Problem-solving ability with a holistic approach

Lonza offers a great working environment where you can develop your skills and expertise in a dynamic industry. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.


About Lonza:


Lonza is a global leader in life sciences operating across three continents. We work in science to improve lives, and we achieve this by bringing talented people together to develop innovative solutions. At Lonza, we respect and protect our people and our environment, and we strive to make a positive impact on the world.


How to Apply:


For more information about this opportunity and to apply, please visit our website.



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