Manufacturing Process Specialist

4 days ago


Copenhagen, Copenhagen, Denmark CBSbutler Full time

At CBSbutler, we're seeking an experienced Process Engineer with a background in Pharma and knowledge of fill finish packaging and solvents media preparation to oversee technical transfer activities.

  • Responsibilities:
  • Authoring and reviewing essential GMP documentation, including Master Batch Records, change controls, protocols, reports, qualifications, and regulatory submissions.
  • Interpreting and applying GMP requirements and current regulations, developing standardized procedures in collaboration with Operations, Quality, and External Partners.
  • Ensuring 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.

We're looking for someone with 3-5 years of experience in fill finish manufacturing, a Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, and hands-on experience with membrane in-gel water cleaning processes.

Seniority level

Mid-Senior level

Employment type

Contract



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