Technical Writer Engineer

Le poste :

The Technical Writer owns the complete technical documentation of a new continuous control machine used for in-process control in pharmaceutical production: design specifications (PDS, FDS, HDS, SDS), user manual and maintenance protocols,… all written in English.

You do not wait for information to reach you: you go and get it from the development team, build a full understanding of the machine and its process, and structure each document in line with the documentation already in place for our other machines.

Duties & Responsibilities

- Write, structure and maintain the complete documentation set: Product (PDS), Functional (FDS), Hardware (HDS) and Software (SDS) Design Specifications, user manual, maintenance protocols and related documents.
- Proactively collect information at the source: interview the developers (software, electronics, mechanics, automation), attend design reviews and tests, and challenge incomplete or ambiguous input.
- Build an end-to-end understanding of the machine and its process before writing.
- Apply the structure, templates and terminology used for the company's other machines, keeping the documentation consistent across the product range.
- Create or coordinate supporting visuals: diagrams, flow charts, screenshots.
- Manage the document lifecycle: drafts, reviews, approval, versioning and updates following design changes.
- Support GMP / GAMP 5 documentation expectations and customer qualification activities by creating test protocols (FAT/SAT/ IQ / OQ).

Profil :

- Technical background (Engineering, industrial sciences, electromechanics, process).
- Experience writing technical documentation for machines, equipment or software; experience in the pharmaceutical or another regulated industry is a strong asset.
- Good understanding of multidisciplinary systems combining mechanics, electronics, automation and software.
- Knowledge of GMP / GAMP 5 documentation practices and equipment qualification (IQ / OQ) is an asset.
- Familiarity with document management or PLM systems is a plus.

- Proactive and autonomous: comfortable approaching developers, asking questions and digging until the information is complete.
- Able to turn complex technical input into clear, unambiguous text adapted to each audience (technicians, operators, customer quality teams).
- Structured and rigorous, with genuine attention to detail and consistency.
- Excellent written English – all documentation is produced in English; working knowledge of French and English for daily spoken collaboration.
- Proficient with MS Word (styles, templates, long structured documents) and diagramming tools (e.g. Draw.io).

A propos de nous :

We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life.