CMC Process Technical Writer Pharmaceuticals Belgium

Location: On-site - Belgium, Near Brussels

Start Date: ASAP

Duration: Initial 6-9 months

Availability: Up to 5 days/week (flexible)

Languages: Fluent in English and French

A leading biotech company is seeking a freelance Technical Writer to support documentation activities related to the launch of a new clinical manufacturing facility focused on gene therapy. This role sits within the process engineering team, which is responsible for the implementation and qualification of manufacturing processes and equipment.

Key Responsibilities:

• Draft and manage high-quality GMP-compliant documents including:
• Standard Operating Procedures (SOPs)
• Batch records
• Process descriptions
• Risk assessments
• Protocols and reports
• Collaborate with subject matter experts across production, quality, compliance, and engineering to gather and structure technical content
• Coordinate document reviews, approvals, and version control using internal documentation systems
• Support GMP readiness and contribute to the successful introduction of new manufacturing capabilities

Ideal Profile:

• 5+ years of industry experience in a biotech, pharmaceutical, or clinical manufacturing environment
• Strong technical background in process engineering
• Previous experience with GMP documentation and regulatory standards
• Excellent technical writing skills in both French and English
• Proficient with tools like Microsoft Office and electronic document management systems
• Self-directed, organized, and comfortable working in a fast-paced environment

This is an exciting opportunity for someone with a solid engineering foundation and a passion for translating complex technical processes into clear, compliant documentation.