Technical Writer

HAL Allergy Group; Leiden; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

30 leave days

Pension contribution

Health insurance

Job summary

HAL Allergy Group in Leiden is seeking a Technical Writer to join the Technology Transfer team. You will translate complex manufacturing processes into high-quality batch records, SOPs, and operational documents that support safe, compliant production.

You will collaborate with SMEs, support change controls, CAPAs, and continuous improvement, and train operators on new batch records, ensuring effective knowledge transfer across projects in a GMP setting.

Qualifications

• 2–3 years of experience in pharmaceutical/biotech regulated industry.
• Experience with Microsoft Word and MS Office.
• Strong written and spoken English and Dutch communication.
• Understanding of pharmaceutical manufacturing processes (formulation, fill-finish, lyophilization).
• Knowledge of GMP requirements and documentation practices.

Responsibilities

• Create and maintain Master Batch Records (MBRs) and Batch Records for new products and processes.
• Update manufacturing documentation as part of change controls, CAPAs, and continuous improvement.
• Develop, manage, and improve document templates for GMP operations.
• Collaborate with subject matter experts to translate technical information into compliant docs.
• 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 knowledge transfer.
• Create and maintain SOPs within the Technology Transfer department.

Skills

Documentation

Communication

GMP knowledge

Pharma processes

Tools

Microsoft Word

Job description

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.

You have

• 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.

Who are we looking for?

• 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.

Our offer

• 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.
• 30 leave days.
• Company contribution to a pension package and health insurance.

HAL Allergy, for those who seek pharmaceutical innovation

HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity!

HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.