Technical Writer
Marketing & Communications, IT
General information
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.
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
- Being part of a company that is geared towards helping people live happier and healthier lives.
- A competitive salary that matches your responsibilities and experience.
- A 13th month salary
- 30 leave days.
- Company contribution to a pension package and health insurance.

