Filling Expert

Filling Expert 📍 Brussels Area, BelgiumAbout NalysNalys 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 & ResponsibilitiesAs 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) inputsEnsuring 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 teamsProviding inputs for utility and HVAC loads, and supporting the development of the availability model based on cleaning and changeover timesOutlining 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 & QualificationsYou hold a degree in Engineering, Life Sciences, or a related technical fieldYou have proven experience in sterile fill-finish operations, particularly with syringes and cartridgesYou have hands-on experience with isolator technology and aseptic processingYou are familiar with GMP Annex 1 requirements and have contributed to EM and CCS strategiesYou have a strong understanding of filling line architecture, including de-nesting/nesting, checkweighing, stopper/cap feeding, and reject systemsYou are detail-oriented and proactive in identifying design risks and ensuring robust layouts from the startYou are fluent in English (written and spoken); French is a plusYou thrive in cross-functional environments and are comfortable working with engineering partners, QA, validation, and operations.The Recruitment ProcessBy 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 screeningYou will meet with our Technical Director, Alexandre Ivankovich for a technical assessmentA 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!