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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.Â
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.Â
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.