Process Engineer H/F/X

Description de l'entreprise

Notre mission? Accompagner les petites et moyennes entreprises, ainsi que les startups du secteur des sciences de la vie et des écosystèmes Tech, dans le développement de leur stratégie RH et dans la mise en place de processus de gestion, d'administration et de développement de leurs R.H.. La gestion de la paie, le recrutement, le coaching, les reportings, l'organisation administrative ou encore les formations sont des éléments essentiels à une bonne politique RH. Nous vous accompagnons pas à pas dans toutes vos démarches et vos besoins en renforçant la culture d'entreprise et en soutenant leurs valeurs, tout en préservant une qualité de vie au travail. Que ce soit pour une aide ponctuelle ou de manière récurrente, nous répondrons présents!

Description de la fonction

Company Overview Are you looking for your next professional challenge? How about being a part of building a new company from the ground up? At White Raven, we have just started business. While we may be a small company, we have big ambitions. Over the last year, we have set up a fully operating pharmaceutical production unit and we are now ramping up its capacity. We believe in purpose, agile mindset, and technology. Purpose: If you're concerned about the final purpose of your job, how about saving lives? Our focus at White Raven is to serve biotech companies, small companies that are currently on the verge of developing new treatments or improving existing treatments. This sector is highly competitive and amazingly complex. Outstanding new technologies are being invented at a very fast pace, allowing for the development of new treatments that go further every year, including cancer treatments and rare diseases. Agile mindset: At White Raven, we are currently a small team of highly skilled experts in our area of expertise. We believe in an agile approach to build exceptional business processes, bring value to our customers, learn, and evolve quickly. We want to work with dynamic and talented individuals who share our mindset. We implement agile processes (Scrum) for daily work and fast and efficient decision-making. Technology: We strongly believe that mastering technology is key to becoming a reference in our area of expertise. That is why we are investing in a state-of-the-art, fully automated production line built around the Cytiva SA25 robotic isolator. That is also why we are building a fully digitalized, end-to-end paperless process (eBMR, Odoo ERP, Scilife QMS), a strong competitive advantage compared with industry standards that remain very paper-based. To make this happen, we are actively looking for a Process Engineer based in Liège (BE) to play a pivotal role in the development of our sterile manufacturing processes. Roles and Responsibilities You will:

Own the design, optimization and continuous improvement of sterile fill and finish processes (formulation, filtration, aseptic filling, visual inspection).

Lead the technical management of New Product Introduction (NPI) and technical transfer for new customer projects, in coordination with the Project Manager and Manufacturing.

Develop validation and transfer strategies; lead process design and technical (process) validation activities.

Work directly with customers on process-related topics throughout their projects.

Author and approve process documents: URS, process validation protocols and reports, work instructions, Master Batch Records.

Lead Quality Risk Management (QRM) and process risk assessments (pFMEA, HACCP) and contribute to the Contamination Control Strategy.

Support the manufacture of clinical batches from a process engineering perspective.

Apply statistical tools (process capability studies, Minitab) to monitor and optimize process performance; lead deviation investigations using structured methodologies (5 Whys, Ishikawa, FMEA).

Ideal Candidate Profile We are looking for an experienced process engineer who combines strong technical ownership, documentation rigor, and a hands-on attitude in a regulated GMP environment.

Education: Master's degree or Engineer in Bio-engineering, Chemical Engineering, Industrial Pharmacy, Biotechnology, or related technical field.

Experience: 10 years in the pharmaceutical industry, including 5 years as a Process Engineer.

Skills: Strong knowledge of fill and finish activities and aseptic processing. Technical management of New Product Introduction (NPI) and technical transfer. Process design, process optimization and validation / transfer strategy development. Quality Risk Management (QRM) and risk assessments (pFMEA or equivalent). Statistical tools for process analysis. Experience working directly with customers. Solid knowledge of EU GMP Annex 1. Experience in biotechnologies / cytotoxic products is a plus.

Digital proficiency: A first experience with any ERP, MES or eQMS system.

AI and automation mindset: Open to working with AI-assisted tools and automated systems; curious about how emerging technologies can accelerate documentation, data analysis, and process improvement.

Language skills: English required (read technical documentation, write reports); French is a plus.

Soft skills: Technical leadership and autonomy; rigor and reliability in execution; team spirit and clear communication with operators, technicians, QA, and engineers.

What We Offer At White Raven, we embrace the vibrant, energizing spirit of a start-up work environment. Our culture fosters creativity, innovation, and collaboration, as we value every team member's ideas and contributions. We believe in maintaining a balanced and stimulating environment that supports learning, ownership, and rapid evolution. This position is a rare opportunity to take technical ownership of process engineering in a cutting-edge technology environment (robotic isolator, single use, end-to-end digitalization, AI-assisted tools), with direct impact on New Product Introduction and customer project delivery. We cherish our diverse and inclusive atmosphere and we ensure every individual feels welcome, comfortable, and empowered to perform at their best. In essence, we combine the agility, passion, and curiosity of a start-up with the ambition to make significant contributions to the industry. How to Apply Interested in joining our team? We would love to hear from you! Application Process:

Apply online: Submit your application through our dedicated portal : https://whiteraven.bio/jobs/process-engineer-13

Required documents: CV and cover letter

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

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