Scientific Writer — GMP Documentation Specialist | Aseptic Fill & Finish - Mission

Recrutis is supporting one of its clients, a major pharmaceutical manufacturing site in the canton of Schaffhausen, in the search for a Scientific Writer — GMP Documentation Specialist, based on site.

Why this role

• A documentation role anchored in a concrete industrial milestone: the start-up of a new filling line and the associated manufacturing areas
• Real technical substance — translating equipment functionality, operational concepts, process flows and supplier information into operating instructions that people actually use on the floor
• Direct exposure to EU GMP Annex 1 expectations, contamination control and cleanroom operations on an aseptic site
• Cross-functional position, interfacing daily with Engineering, Manufacturing, Quality and Compliance
• Long-term assignment with full autonomy on site

Key information

• Location: canton of Schaffhausen, Switzerland — 100% on site
• Contract: long-term consulting assignment, reinforcing the existing documentation team
• Start: as soon as possible — assignment running until end of July 2027
• Languages: strong written communication skills in English and German (knockout)

Scope

• Author, revise and maintain GMP documents, including SOPs and Work Instructions
• Ensure documents are clear, inspection-ready, user-friendly and aligned with applicable GMP requirements, internal quality standards and Annex 1 expectations
• Coordinate document review and approval workflows with Engineering, Manufacturing, Quality, Compliance and other subject matter experts
• Support document lifecycle activities: periodic reviews, change control impact assessments and document updates
• Support the documentation required for new manufacturing areas, equipment and filling-line technologies
• Translate equipment functionality, operational concepts, process flows and supplier information into practical operating instructions
• Produce documentation for equipment operation, cleaning, setup, line clearance, material handling, interventions and routine manufacturing support activities
• Maintain document trackers and readiness overviews for documentation deliverables linked to operational readiness

Profile — Required criteria (knockout)

• Experience in aseptic manufacturing, fill & finish, clinical manufacturing or sterile production environments
• Demonstrated experience authoring or maintaining GMP documentation: SOPs, Work Instructions, forms or training materials
• Strong written communication skills in both English and German
• Good understanding of GMP principles, document control and regulated manufacturing operations
• Understanding of EU GMP Annex 1 expectations, contamination control and cleanroom operations
• Structured, reliable and detail-oriented working style, with the ability to manage several documentation workstreams in parallel
• Availability to work 100% on site in the canton of Schaffhausen

Strong assets — Differentiators

• Previous involvement in a new line or facility start-up programme
• Experience with document management systems and change control tools
• Ability to translate technical complexity into practical, floor-level instructions
• Continuous improvement mindset and demonstrated ownership on documentation deliverables

Process — Confidential recruitment process. Response within 48 hours for applications meeting required criteria. Active mandate, priority review.

Keywords: scientific writer, technical writer, GMP documentation, SOP authoring, work instructions, document control, aseptic manufacturing, fill and finish, sterile production, EU GMP Annex 1, contamination control, cleanroom, filling line start-up, operational readiness, Schaffhausen, Switzerland

Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences