Technical Writer

Are you passionate about creating clear, accurate, and compliant documentation in a GMP-regulated environment? We are looking for a Technical Writer to join our Technology Transfer team.

In this role, you will play a key part in the successful introduction of new pharmaceutical products and processes by developing and maintaining critical manufacturing documentation. You will work closely with cross-functional teams to translate complex production processes into high-quality batch records, procedures, and operational documents that support safe and compliant manufacturing operations.

• Create and maintain Master Batch Records (MBRs) and Batch Records for new products and manufacturing processes.
• Update existing manufacturing documentation as part of change controls, CAPAs, and continuous improvement initiatives.
• Develop, manage, and improve document templates used within GMP manufacturing operations.
• Collaborate with subject matter experts and project teams to gather technical information and translate it into clear, compliant documentation.
• Coordinate document reviews, approvals, and implementation activities.
• Train production operators on new or revised batch records.
• Support Technology Transfer projects by documenting new processes and ensuring sustainable knowledge transfer.
• Create and maintain Standard Operating Procedures (SOPs) within the Technology Transfer department.

• MBO degree or equivalent qualification.
• Preferably 2 to 3 years of experience in the pharmaceutical, biotech, or related regulated industry.
• Experience with Microsoft Office, particularly Microsoft Word.
• Strong written and verbal communication skills in both Dutch and English.
• Understanding of pharmaceutical manufacturing processes such as formulation, fill-finish, and preferably lyophilization.
• Knowledge of GMP requirements and documentation practices.

• Detail-oriented and quality focused.
• Well organized and able to manage multiple documentation activities simultaneously.
• Results-driven and accountable.
• A collaborative team player with strong customer focus.
• Comfortable working with technical information and digital tools.
• Continuously seeking opportunities to improve processes and documentation quality.