Senior Process Engineer

4 days ago


Copenhagen, Copenhagen, Denmark CBSbutler Full time

My client is currently looking for an experienced Process Engineer with a background in Pharma and knowledge fill finish packaging and solvents media preparation.

Description

  • Oversee technical transfer activities by authoring and reviewing 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.
  • Contribute to the development and implementation of best practices and business process strategies through active participation and knowledge sharing.

Requirements

  • Must have fill finish manufacturing experience for this role (Minimum 3-5 years)
  • Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
  • Experience in Fill Finish activities – (Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
  • Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
  • Hands-on experience with membrane in-gel water cleaning processes
Seniority level

Mid-Senior level

Employment type

Contract

Job function

Manufacturing and Supply Chain

Industries

Pharmaceutical Manufacturing, Chemical Manufacturing, and Medical Equipment Manufacturing

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