Biotech Documentation Specialist
This is an exciting opportunity for a skilled technical writer to join our team and support documentation activities related to the launch of a new clinical manufacturing facility focused on gene therapy.
The role sits within the process engineering team, which is responsible for the implementation and qualification of manufacturing processes and equipment. Key Responsibilities include:
* Drafting and managing high-quality GMP-compliant documents including Standard Operating Procedures (SOPs), Batch records, Process descriptions, Risk assessments, Protocols and reports.
* Collaborating with subject matter experts across production, quality, compliance, and engineering to gather and structure technical content.
* Coordinating document reviews, approvals, and version control using internal documentation systems.
Requirements:
* 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.
A key benefit of this role is the opportunity to work in a fast-paced environment and contribute to the successful introduction of new manufacturing capabilities. If you have a solid engineering foundation and a passion for translating complex technical processes into clear, compliant documentation, then this could be the ideal role for you.