Wash & Sterilization SME – Pharmaceutical Engineering
đź“Ť Brussels Area, Belgium (Hybrid)
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 top-tier 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
As a Wash & Sterilization Expert, you will play a key role in the design and implementation of a new multi-product aseptic production facility (syringes & cartridges).
You will act as the owner-side expert during the Basic Design phase, ensuring that all washing and sterilization processes meet GMP and HSE standards while supporting efficient and compliant operations.
This is a strategic role where your expertise will directly influence equipment selection, process design, and validation strategies for critical systems such as autoclaves, utensil washers, and CIP/SIP interfaces.
Your Responsibilities
* Define strategies and technical requirements for:
* Parts/component washing and preparation
* Steam sterilization processes
* CIP/SIP boundaries and rinse quality (PW/WFI)
* Lead the selection and sizing of:
* Utensil washers, COP/SOP systems, and autoclaves
* Develop cycle concepts, load maps, and turnaround time strategies
* Ensure zoning and segregation of clean/dirty flows to protect Grade A/B areas
* Define utility connections (clean steam, WFI/PW, compressed air) and heat-load inputs
* Contribute to transfer strategies to filling/isolators and material handling interfaces
* Author and review key design documents:
* URS, PFDs/P&IDs, equipment lists, utility load lists, and tie-in matrices
* Provide inputs to room data sheets (RDS) including finishes, drainage, air changes, and pressure cascades
* Collaborate closely with QA, Validation, HSE, and Operations to ensure GMP Annex 1 readiness.
Your Profile
* You have proven experience in aseptic processing, particularly in washer/autoclave cycle development and qualification
* You’ve successfully reduced turnaround times without compromising sterility assurance
* You are proactive and detail-oriented, with a strong understanding of GMP and cleanroom zoning
* You are fluent in English (written and spoken); French is a plus
* You thrive in cross-functional environments and are comfortable leading technical discussions with engineering partners and internal stakeholders
* You are committed to delivering zero late changes at execution due to missing assumptions environment.
The Recruitment Process
Here are the different steps you will go through by applying for the position of "Wash & Sterelization Expert" :
* Screening Call with Olivia Braszko, Talent Acquisition Specialist at Nalys
* Technical Interview with Alexandre Ivankovich, Technical Director
* Final Interview with Jimmy Rousseaux, Business Unit Director.
💬 If you're passionate about aseptic manufacturing and want to shape the future of pharmaceutical production, we’d love to hear from you!