Senior Process Engineer Leader

7 days ago


Copenhagen, Copenhagen, Denmark CBSbutler Full time
Job Overview

CBSbutler is currently seeking a highly experienced Process Engineer to join their team. As a key member of the operations department, you will be responsible for overseeing technical transfer activities, ensuring compliance with GMP requirements, and developing standardized procedures.

This is an excellent opportunity for a skilled engineer to utilize their expertise in fill finish manufacturing, sterilization, and aseptic processing to drive business process improvements and contribute to the development of best practices.

Key Responsibilities
  • Author and review essential GMP documentation, including Master Batch Records, change controls, protocols, reports, qualifications, and regulatory submissions.
  • Interpret and apply GMP requirements and current regulations, developing standardized procedures in collaboration with Operations, Quality, and External Partners.
  • Ensure External Partners maintain inspection readiness for routine audits and inspections related to new product introductions or transfers, coordinating efforts with Operations, Quality, and Regulatory teams.
Requirements
  • A minimum of 3-5 years of experience in fill finish manufacturing.
  • A Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or a related science or engineering field.
  • Hands-on experience with membrane in-gel water cleaning processes and statistics, including Proactive Process Analysis and Continuous Process Verification.


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