Filling Expert
đź“Ť Brussels Area, Belgium
About Nalys
Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. For over 15 years, we’ve partnered with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.
Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.
The Role & Responsibilities
As a Filling Expert (SME), you will play a key role in the development of a new multi-product sterile manufacturing facility (syringes & cartridges) for one of our pharmaceutical partners in the Brussels area. You will act as the owner-side expert during the Basic Design phase, ensuring that the filling process design meets regulatory expectations, operational needs, and technical excellence.
Your responsibilities will include:
* Translating product and format strategies into clear, executable design deliverables for two filling lines (syringes and cartridges)
* Defining and reviewing the User Requirement Specifications (URS), layouts, and Room Data Sheets (RDS) inputs
* Ensuring compliance with GMP Annex 1, including zoning, environmental monitoring (EM), and contamination control strategy (CCS)
* Leading or participating in design reviews (Design Basis, Concept, Basic Design Freeze).
* Managing interface definitions and coordinating with component preparation, inspection, and packaging teams
* Providing inputs for utility and HVAC loads, and supporting the development of the availability model based on cleaning and changeover times
* Outlining validation strategies (FAT/SAT/IOQ split) and supporting vendor pre-selection for key equipment (e.g., peristaltic pumps, isolators)
* Collaborating closely with QA, Validation, HSE, and Operations teams to ensure seamless integration and readiness.
Skills & Qualifications
* You hold a degree in Engineering, Life Sciences, or a related technical field
* You have proven experience in sterile fill-finish operations, particularly with syringes and cartridges
* You have hands-on experience with isolator technology and aseptic processing
* You are familiar with GMP Annex 1 requirements and have contributed to EM and CCS strategies
* You have a strong understanding of filling line architecture, including de-nesting/nesting, checkweighing, stopper/cap feeding, and reject systems
* You are detail-oriented and proactive in identifying design risks and ensuring robust layouts from the start
* You are fluent in English (written and spoken); French is a plus
* You thrive in cross-functional environments and are comfortable working with engineering partners, QA, validation, and operations.
The Recruitment Process
By applying for the Filling SME position, you will go through the following steps:
* Olivia Braszko, Talent Acquisition Specialist, will review your application and schedule an initial screening
* You will meet with our Technical Director, Alexandre Ivankovich for a technical assessment
* A final interview will be held with our Business Unit Director, Jimmy Rousseaux.
If you're passionate about sterile manufacturing and want to contribute to a cutting-edge pharmaceutical project, we’d love to hear from you!