Aseptic Filling Engineers

Location: Denmark (On-site)
Contract: Freelance / Consultant
Duration: Long-term project

Overview

We are supporting a major pharmaceutical manufacturing project in Denmark and are looking for experienced CQV and Validation professionals with strong aseptic filling experience.

This role will focus on the qualification and validation of critical sterile manufacturing equipment and processes within a GMP-regulated environment. Candidates should have hands-on experience with aseptic filling operations and associated sterilisation and bio-decontamination systems.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for aseptic manufacturing equipment.
• Develop and review qualification protocols and reports (IQ, OQ, PQ).
• Support FAT, SAT, commissioning, and startup activities.
• Qualify and validate equipment including:
  • Aseptic filling lines
  • Washing machines
  • Autoclaves
  • VHP/BHP decontamination systems
  • Sterilisation chambers
  • Isolators and RABS
• Ensure compliance with GMP and regulatory requirements.
• Collaborate with engineering, manufacturing, quality, and project teams.
• Support deviation investigations, risk assessments, and change controls where required.

Requirements

• Previous experience within sterile pharmaceutical manufacturing.
• Strong background in aseptic filling / fill-finish operations.
• Experience qualifying equipment such as autoclaves, washers, isolators, VHP/BHP systems, and filling lines.
• Proven knowledge of IQ/OQ/PQ execution.
• Familiarity with GMP, Annex 1, and sterile manufacturing regulations.
• Experience on large capital projects, facility expansions, or greenfield/brownfield projects is highly advantageous.
• Fluent English required.

Ideal Background

We are particularly interested in professionals who have worked as:

• CQV Engineer
• Senior CQV Engineer
• Validation Engineer
• Process Validation Engineer
• Sterility Assurance Engineer
• Aseptic Process Engineer
• Fill Finish Engineer
• Technical Services / MSAT Engineer
• Qualification Specialist