Senior Process Engineer – Fill & Finish | Belgium
Location: Belgium
Industry: Pharmaceutical / Biotech
Contract: Consulting mission (freelance / consultancy)
Start: ASAP | Duration: 4 months
About the Role
Elitium Consult is seeking a Senior Process Engineer to support the introduction of new pharmaceutical products within a state-of-the-art aseptic manufacturing environment.
This is a high-impact role focused on:
Fill & Finish operations
New Product Introduction (NPI)
Technology Transfer
Process Validation
You will act as the key technical interface for clients and collaborate closely with Manufacturing, QA, and Supply Chain teams.
Key Responsibilities
• Lead sterile Fill & Finish process engineering activities
• Drive NPI and technology transfer projects
• Define and execute validation strategies (PPQ, process validation)
• Optimize aseptic processes (formulation, filtration, filling, inspection)
• Write and review URS, protocols, reports, batch records, WIs
• Lead QRM activities (pFMEA, HACCP, contamination control)
• Support clinical & commercial manufacturing campaigns
• Perform statistical process analysis (Minitab or equivalent)
• Act as technical interface with clients across projects
Profile Required
Master's degree (Engineering / Bioengineering / Pharma / Chemical Engineering)
10+ years in pharmaceutical industry
Strong expertise in:
• Aseptic Fill & Finish
• Sterile manufacturing
• NPI & Technology Transfer
• Process Validation
• EU GMP / Annex 1
• QRM (pFMEA, HACCP)
Experience with Minitab / statistical tools
ERP / MES / eQMS exposure
Fluent English (French is a plus)
Nice to Have
• Biotech manufacturing experience
• Cytotoxic products exposure
• Single-use & isolator systems knowledge
Why Join?
Join a cutting-edge aseptic manufacturing environment and contribute to the successful launch of innovative pharmaceutical products in a highly technical, client-facing role.
Interested?
Send your CV to:
or connect with me directly on LinkedIn.
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