Process Engineer

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.

Role Summary

As a Process Engineer, you will join the Process Engineering team and report directly to the COO. You will own the full process lifecycle, from process design and qualification to clinical and GMP batch execution and post-batch data analysis, within our Grade C cleanroom and Cytiva SA25 robotic isolator environment.

This is a senior role for an experienced engineer who will take technical ownership of New Product Introduction, process design, technical validation, and continuous improvement of our aseptic fill and finish 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 autom