Single Use Development Engineer

Aseptic Technologies; Gembloers; Presencial; EUR 60.000 - 85.000; Jornada completa

Descripción de la vacante

Aseptic Technologies in Belgium is seeking a Senior Engineer to lead Single-Use system design from initial client meeting to commercial production. You will translate requirements into technical specifications and guide development with R&D, Quality, and Production teams.

You will design architectures using CAD, source components, manage the development lifecycle, and ensure GMP-compliant cleanroom assembly. Fluency in French and English is required.

Formación

• Master’s degree in a relevant engineering field is required.
• 3–5 years in product design, R&D, or development engineering, preferably in SUS or biopharma.
• Fluent in French and English, written and spoken.

Responsabilidades

• Lead technical workshops and client meetings to capture requirements and translate them into regulatory-compliant specifications.
• Design assembly architectures using 2D/3D CAD and select components with qualified suppliers.
• Coordinate the development lifecycle from prototype to commercial production and interface with R&D, Quality, Production, Supply Chain, and Commercial teams.
• Prepare technical files, drawings, and manufacturing procedures; support cleanroom assembly feasibility and quality.

Conocimientos

French (Fluent)

English (Fluent)

Single-Use assembly components knowl

Educación

Master’s degree in Bioengineering, Materials Science, Mechanical Engineering, Biomedical Engineering, or equivalent

Herramientas

CAD software

Descripción del empleo

Are you passionate about the biopharmaceutical sector and looking to be at the heart of product innovation? Do you excel in Single-Use System design and enjoy leading a project from the initial client meeting all the way through to commercial production?

Your Mission

Reporting directly to the Head of Operations - SUS, you will play a key role at the intersection of technical innovation, customer satisfaction, and operational excellence. Working in close collaboration with the Commercial, Quality, and Production teams, you will serve as the technical pillar for the development and continuous improvement of our clients' Single-Use assemblies.

Your Responsibilities

• Engineering & Client Relations: Lead technical workshops and meetings with clients to understand their processes and operational constraints. Translate their requirements into precise, realistic technical specifications that comply with regulatory standards.
• Design & Technical Sourcing: Design assembly architectures using 2D/3D modeling software. Source, qualify, and select optimal components (tubing, connectors, sterile couplings, bags, packaging). Evaluate the physicochemical and functional compatibility of sourced components with clients' fluids and processes.
• Project Management & Cross-Functional Coordination: Coordinate the development lifecycle from the conceptual/prototype phase through to commercial industrialization. Ensure a seamless, continuous interface with both internal stakeholders (R&D, Quality, Production, Supply Chain, Commercial) and external partners (suppliers, clients).
• Production Transfer & Technical Documentation: Prepare all technical files, including finished product specifications, 2D/3D assembly drawings, ERP part master records, and manufacturing/assembly procedures. Provide ongoing technical support to production teams to guarantee cleanroom assembly feasibility and quality.

Your Profile

• Education: Master’s degree / Engineering degree (Bioengineering, Materials Science, Mechanical Engineering, Biomedical Engineering, or equivalent advanced degree).
• Experience: Minimum 3 to 5 years of experience in product design, R&D, or development engineering, ideally gained in the Single-Use technology sector, the biopharmaceutical industry, or cell and gene therapy.
• Languages: Fluent in French and English.
• Technical Skills: Solid mastery of Single-Use assembly components and their specifics (regulatory standards, sterilization, integrity); proficiency in CAD / 2D or 3D design software; good knowledge of associated manufacturing processes and strict quality standards (GMP environment, cleanrooms, ISO, USP, EP).
• Soft Skills:

• Excellent communication & client orientation: Ability to convey complex technical details clearly and negotiate them with diverse stakeholders.
• Project management & influential leadership: Ability to manage multiple priorities and build alignment across cross-functional teams.
• Analytical mindset & rigor: Methodical, structured, and problem-solving oriented.
• Entrepreneurial spirit: Ability to devise and implement innovative solutions, independently challenging the status quo.

Why Join Us?

• A strategic role: You will have a direct impact on company performance and customer satisfaction.
• A stimulating environment: Join an innovative, human-scale organization within a fast-growing group and industry.
• Career development: Continuous growth and opportunities within the SKAN group.

Join us and take part in an exciting journey!