CSV Documentation Expert (Production & Cleaning Equipment)

Independently manage the creation, revision, and maintenance of all user documentation (operational handbooks, user instructions, procedures) for new equipment on both the production side and the cleaning side , ensuring full compliance with CSV/GAMP5 requirements and cGMP regulations (FDA, EMA).

• Draft Operational Handbooks for new equipment in accordance with CSV principles (accuracy, traceability, version control).
• Manage the document lifecycle : creation, review, approval, archiving, and obsolescence.
• Align documentation with validation plans and data integrity requirements (ALCOA+).
• Collaborate with Engineering, Automation, QA, and Validation teams to gather technical and regulatory inputs.
• Train operators on the correct use of manuals and adherence to documented procedures.
• Write operational handbooks for production equipment (e.g., bioreactors, filling lines, mixers, process skids).
• Clearly and compliantly describe operator-machine interactions, including HMI/SCADA interfaces.
• Integrate instructions for handling process alarms , setup, shutdown, and preliminary cleaning (if not dedicated).
• Write operational handbooks for cleaning equipment (e.g., CIP/SIP systems, parts washers, drying tunnels, automated detergency systems).
• Document cleaning cycles, critical parameters (time, temperature, detergent concentration, flow rate), and post-cleaning verifications.
• Ensure documentation supports cleaning validation from both a documentary and CSV perspective.
• At least 5 years of proven experience in similar roles (Technical Writer, CSV Specialist, Documentation Specialist) in GMP environments.
• In-depth knowledge of regulations: GAMP5 , 21 CFR Part 11 , EU Annex 11 , Data Integrity .
• Experience writing User Requirement Specifications (URS) , SOPs , and user manuals for complex machinery.
• Ability to read and interpret P&IDs, flow diagrams, and control logic (without necessarily being a programmer).
• Excellent technical English (documents often written in English).
• High attention to detail, methodical approach, compliance mindset, and clarity in writing.

Preferred qualifications

• CSV certifications (e.g., ISPE GAMP).
• Experience with both production and cleaning equipment in the same role.
• Knowledge of Document Management Systems (DMS) such as Veeva, Documentum, MasterControl.